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Recalls affecting Hawaii

Data last updated: September 8, 2026 at 1:13 PM UTC

16,268 recalls found

Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

▸Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

B. Braun — 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

▸Full report
Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

American Regent, Inc. — Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

▸Full report
Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

▸Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced August 31, 2026

Kofinas — Garlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

▸Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenUndeclaredAnnounced August 31, 2026

Little Temptations — Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

▸Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced August 29, 2026

Everything Sprouts — Robust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
NewestOldest
High riskLow riskAll
Wording
Class IHigh risk
FoodBacteria/virusRecalled May 5, 2026

Southern Style Nuts Gourmet Hunter Mix 23 oz plastic jar UPC 085839073319 and 36 oz plastic jar UPC 085839071483. 23 oz 6 jars per case case and 96 jars per display. 36 oz 6 jars per case

Potential presence of Salmonella

ALL 50 STATES
▸Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0831-2026
Lot/product code:
BEST BY 01/28/27 BEST BY 02/05/27 BEST BY 02/12/27 BEST BY 02/17/27 BEST BY 03/03/27 BEST BY 03/14/27 BEST BY 02/05/27 BEST BY 26/FEB/2027 BEST BY 13/MAR/2027 BEST BY 02/APR/2027
Recalling firm:
JOHN B SANFILIPPO & SONS INC
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusRecalled May 5, 2026

Squirrel Brand Town & Country Mix 16 oz can UPC 07223805251 and 7.5 oz can UPC 07223805450. 16 oz 12 cans per case. 7.5 oz 6 cans per case

Potential presence of Salmonella

ALL 50 STATES
▸Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0834-2026
Lot/product code:
BEST BY 05/01/27 BEST BY 05/25/27 BEST BY 05/28/27 BEST BY 02/10/27
Recalling firm:
JOHN B SANFILIPPO & SONS INC
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusRecalled May 5, 2026

Squirrel Brand Travelers Mix 16 oz can UPC 07223899166, 12 cans per case

Potential presence of Salmonella

ALL 50 STATES
▸Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0833-2026
Lot/product code:
BEST BY 04/30/27 BEST BY 05/28/27 BEST BY 06/24/27
Recalling firm:
JOHN B SANFILIPPO & SONS INC
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled May 4, 2026

Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10.

Failed Impurities/Degradation Specifications

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0539-2026
Lot/product code:
Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.
Recalling firm:
Sagent Pharmaceuticals
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B; 2) CARDIAC SURGERY, Medline Kit/SKU DYNJ911589A; 3) CAROTID ENDARTECOMY, Medline Kit/SKU DYNJ36211D; 4) CHLA ECMO / CARDIAC PACK, Medline Kit/SKU DYNJ87973; 5) CHLA ECMO / CARDIAC PACK, Medline Kit/SKU DYNJ87973A; 6) CV PART 1 AND 2, Medline Kit/SKU DYNJ908879; 7) CV PART 1 AND 2, Medline Kit/SKU DYNJ908879C; 8) FEM POP CDS, Medline Kit/SKU CDS983670K; 9) LAP BASIN TRAY, Medline Kit/SKU DYNJ50908B; 10) OPEN HEART LTX CATHETERS KIT, Medline Kit/SKU DYNJ0049032A; 11) OPEN HEART PACK, Medline Kit/SKU DYNJ80549C; 12) OPEN HEART PACK, Medline Kit/SKU DYNJ80549D; 13) RR-ADULT ECMO PACK, Medline Kit/SKU DYNJ69742B; 14) TAVR, Medline Kit/SKU DYNJ906509C.

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98994
Lot/product code:
Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 23JBM539; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 23IBF088; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 23FBM203; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22JBK233; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22JBB115; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22IBO304; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22HBR331; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22FBM460; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22DBS093; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22CBJ072; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22BBX288; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 21LBU240; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 21JBP452; Medline Kit Number/SKU DYNJ911589A: UDI/DI 10198459646102 (each), 40198459646103 (case), Lot Number 26CBD487; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case), Lot Number 24EBB811; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case), Lot Number 24ABV035; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case), Lot Number 23LBG394; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case), Lot Number 23KBA664; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case), Lot Number 23HBC987; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case), Lot Number 23GBQ638; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case), Lot Number 23EBM118; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case), Lot Number 23DBB008; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case), Lot Number 22KBR412; Medline Kit Number/SKU DYNJ87973: UDI/DI 10198459085031 (each), 40198459085032 (case), Lot Number 24HMH646; Medline Kit Number/SKU DYNJ87973A: UDI/DI 10198459159633 (each), 40198459159634 (case), Lot Number 24JMG070; Medline Kit Number/SKU DYNJ908879: UDI/DI 10195327203429 (each), 40195327203420 (case), Lot Number 22HBX489; Medline Kit Number/SKU DYNJ908879C: UDI/DI 10195327690885 (each), 40195327690886 (case), Lot Number 24KBD462; Medline Kit Number/SKU DYNJ908879C: UDI/DI 10195327690885 (each), 40195327690886 (case), Lot Number 24IBQ955; Medline Kit Number/SKU DYNJ908879C: UDI/DI 10195327690885 (each), 40195327690886 (case), Lot Number 24GBA028; Medline Kit Number/SKU DYNJ908879C: UDI/DI 10195327690885 (each), 40195327690886 (case), Lot Number 24FBI615; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 26BBJ555; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 26BBB853; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 25LBA306; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 25IBD419; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 25HBM069; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 25GBT806; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 25GBB405; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 25DBE889; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 25CBT575; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 25ABT789; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 25ABJ907; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 24LBI235; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 24KBQ247; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 24JBT379; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 24IBT329; M… (truncated, 9891 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYNC1816, 15 Fr; 2. DYND10350, 15 Fr.

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98994
Lot/product code:
1. DYNC1816, UDI/DI 10080196990627 (each), 40080196990628 (case); 2. DYND10350, UDI/DI 10080196028665 (each), 40080196028666 (case). ALL LOTS
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 14 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR14C

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98994
Lot/product code:
UDI/DI 10197344148998 (each), 20197344148995 (case); ALL LOTS
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL, Medline Kit Number/SKU DYNJ68302

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98994
Lot/product code:
UDI/DI 10193489820478 (each), 40193489820479 (case), Lot Numbers: 24CBL413, 24ABX694, 23JBY172, 23IBI716, 23DBG873, 23BBR326, 23ABH376, 22KBS634, 22JBS743, 22FBT429, 22BBZ842, 22BBK836, 21BBG579, 21ABO658.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall documents for a full list of products)

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98994
Lot/product code:
Medline Kit Number/SKU CDS983773G: UDI/DI 10193489344240 (each), 40193489344241 (case), Lot Number 21ABD933; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22IBJ338; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22EBL456; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22EBL231; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22BBW955; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22ABC123; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21IBM442; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21IBI539; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21FBT730; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21EBA066; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21CBW872; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Number 23HBV936; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Number 23HBL135; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Number 23HBH924; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Number 23GBT133; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Number 23GBD523; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Number 23ABM749; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Number 22JBH775; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24EDB118; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24DDC044; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24BDB774; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24ADB944; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24ADA835; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24ADA564; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 23KDB417; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 21KDB767; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 21IDC416; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24BDB595; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24ADB653; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 22DDA063; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 23JBQ990; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 23GBS121; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 22HBB007; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 22FBC016; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 22BBE079; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 22ABJ835; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 21IBG139; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 21BBA612; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 21ABU423; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 21ABP812; Medline Kit Number/SKU DYNJ905177B: UDI/DI 10193489940497 (each), 40193489940498 (case), Lot Number 21LMG772; Medline Kit Number/SKU DYNJ905177B: UDI/DI 10193489940497 (each), 40193489940498 (case), Lot Number 21LMF805; Medline Kit Number/SKU DYNJ905177B: UDI/DI 10193489940497 (each), 40193489940498 (case), Lot Number 21KMD456; Medline Kit Number/SKU DYNJ905177B: UDI/DI 10193489940497 (each), 40193489940498 (case), Lot Number 21KMC752; Medline Kit Number/SKU DYNJ905177B: UDI/DI 10193489940497 (each), 40193489940498 (case), Lot Number 21KMA494; Medline Ki… (truncated, 591332 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B; 2) CARDIAC SURGERY, Medline Kit/SKU DYNJ911589A; 3) CAROTID ENDARTECOMY, Medline Kit/SKU DYNJ36211D; 4) CHLA ECMO / CARDIAC PACK, Medline Kit/SKU DYNJ87973; 5) CHLA ECMO / CARDIAC PACK, Medline Kit/SKU DYNJ87973A; 6) CV PART 1 AND 2, Medline Kit/SKU DYNJ908879; 7) CV PART 1 AND 2, Medline Kit/SKU DYNJ908879C; 8) FEM POP CDS, Medline Kit/SKU CDS983670K; 9) LAP BASIN TRAY, Medline Kit/SKU DYNJ50908B; 10) OPEN HEART LTX CATHETERS KIT, Medline Kit/SKU DYNJ0049032A; 11) OPEN HEART PACK, Medline Kit/SKU DYNJ80549C; 12) OPEN HEART PACK, Medline Kit/SKU DYNJ80549D; 13) RR-ADULT ECMO PACK, Medline Kit/SKU DYNJ69742B; 14) TAVR, Medline Kit/SKU DYNJ906509C.

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98994
Lot/product code:
Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 23JBM539; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 23IBF088; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 23FBM203; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22JBK233; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22JBB115; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22IBO304; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22HBR331; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22FBM460; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22DBS093; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22CBJ072; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22BBX288; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 21LBU240; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 21JBP452; Medline Kit Number/SKU DYNJ911589A: UDI/DI 10198459646102 (each), 40198459646103 (case), Lot Number 26CBD487; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case), Lot Number 24EBB811; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case), Lot Number 24ABV035; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case), Lot Number 23LBG394; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case), Lot Number 23KBA664; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case), Lot Number 23HBC987; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case), Lot Number 23GBQ638; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case), Lot Number 23EBM118; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case), Lot Number 23DBB008; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case), Lot Number 22KBR412; Medline Kit Number/SKU DYNJ87973: UDI/DI 10198459085031 (each), 40198459085032 (case), Lot Number 24HMH646; Medline Kit Number/SKU DYNJ87973A: UDI/DI 10198459159633 (each), 40198459159634 (case), Lot Number 24JMG070; Medline Kit Number/SKU DYNJ908879: UDI/DI 10195327203429 (each), 40195327203420 (case), Lot Number 22HBX489; Medline Kit Number/SKU DYNJ908879C: UDI/DI 10195327690885 (each), 40195327690886 (case), Lot Number 24KBD462; Medline Kit Number/SKU DYNJ908879C: UDI/DI 10195327690885 (each), 40195327690886 (case), Lot Number 24IBQ955; Medline Kit Number/SKU DYNJ908879C: UDI/DI 10195327690885 (each), 40195327690886 (case), Lot Number 24GBA028; Medline Kit Number/SKU DYNJ908879C: UDI/DI 10195327690885 (each), 40195327690886 (case), Lot Number 24FBI615; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 26BBJ555; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 26BBB853; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 25LBA306; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 25IBD419; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 25HBM069; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 25GBT806; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 25GBB405; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 25DBE889; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 25CBT575; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 25ABT789; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 25ABJ907; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 24LBI235; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 24KBQ247; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 24JBT379; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 24IBT329; M… (truncated, 9891 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D & C, VPH LITHOTOMY MINOR, TRMC- PERI GYN PACK, RICH MINOR LITHOTOMY, etc. (see recall documents for a full list of products)

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98994
Lot/product code:
Medline Kit Number/SKU DYNJ83242B: UDI/DI 10198459157028 (each), 40198459157029 (case), Lot Number 25HBR321; Medline Kit Number/SKU DYNJ83242B: UDI/DI 10198459157028 (each), 40198459157029 (case), Lot Number 25GBD202; Medline Kit Number/SKU DYNJ83242B: UDI/DI 10198459157028 (each), 40198459157029 (case), Lot Number 25FBK813; Medline Kit Number/SKU DYNJ83242B: UDI/DI 10198459157028 (each), 40198459157029 (case), Lot Number 25EBG207; Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each), 40195327193455 (case), Lot Number 23FBK499; Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each), 40195327193455 (case), Lot Number 23EBV071; Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each), 40195327193455 (case), Lot Number 22KBK089; Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each), 40195327193455 (case), Lot Number 22IBV707; Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each), 40195327193455 (case), Lot Number 22HBC310; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 26DMG168; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 26CMD637; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 25KMC849; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 25JMA672; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 25DMC189; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 25CMH655; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 25CMC735; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 24KMA168; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 24IMD969; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 24GMF018; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 24EMA387; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 23LBR964; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 23KBR832; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 23JBE549; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21LME546; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21KMG048; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21JMH240; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21IMC541; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21GMD231; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21DME148; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21CMC690; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 25HBB990; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 25FBO533; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 25EBA604; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 25CBB580; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 25ABE166; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 24IBR571; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 24HBU707; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 24HBA096; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 24DBC284; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 24CBF095; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 24BBA310; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 24ABM210; Medline Kit Number/SKU DYNJ58848A: UDI/DI 10193489750089 (each), 40193489750080 (case), Lot Number 21DBB421; Medline Kit Number/SKU DYNJ58848A: UDI/DI 10193489750089 (each), 40193489750080 (case), Lot Number 21BBO116; Medline Kit Number/SKU DYNJ41314: UDI/DI 10884389909201 (each), 40884389909202 (case), Lot Number 21GBR980; Medlin… (truncated, 62445 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D & C, VPH LITHOTOMY MINOR, TRMC- PERI GYN PACK, RICH MINOR LITHOTOMY, etc. (see recall documents for a full list of products)

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98994
Lot/product code:
Medline Kit Number/SKU DYNJ83242B: UDI/DI 10198459157028 (each), 40198459157029 (case), Lot Number 25HBR321; Medline Kit Number/SKU DYNJ83242B: UDI/DI 10198459157028 (each), 40198459157029 (case), Lot Number 25GBD202; Medline Kit Number/SKU DYNJ83242B: UDI/DI 10198459157028 (each), 40198459157029 (case), Lot Number 25FBK813; Medline Kit Number/SKU DYNJ83242B: UDI/DI 10198459157028 (each), 40198459157029 (case), Lot Number 25EBG207; Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each), 40195327193455 (case), Lot Number 23FBK499; Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each), 40195327193455 (case), Lot Number 23EBV071; Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each), 40195327193455 (case), Lot Number 22KBK089; Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each), 40195327193455 (case), Lot Number 22IBV707; Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each), 40195327193455 (case), Lot Number 22HBC310; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 26DMG168; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 26CMD637; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 25KMC849; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 25JMA672; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 25DMC189; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 25CMH655; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 25CMC735; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 24KMA168; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 24IMD969; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 24GMF018; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 24EMA387; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 23LBR964; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 23KBR832; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 23JBE549; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21LME546; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21KMG048; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21JMH240; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21IMC541; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21GMD231; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21DME148; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21CMC690; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 25HBB990; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 25FBO533; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 25EBA604; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 25CBB580; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 25ABE166; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 24IBR571; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 24HBU707; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 24HBA096; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 24DBC284; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 24CBF095; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 24BBA310; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 24ABM210; Medline Kit Number/SKU DYNJ58848A: UDI/DI 10193489750089 (each), 40193489750080 (case), Lot Number 21DBB421; Medline Kit Number/SKU DYNJ58848A: UDI/DI 10193489750089 (each), 40193489750080 (case), Lot Number 21BBO116; Medline Kit Number/SKU DYNJ41314: UDI/DI 10884389909201 (each), 40884389909202 (case), Lot Number 21GBR980; Medlin… (truncated, 62445 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Medical Procedure Kits labeled as: ADULT TRACHEOSTOMY TUBE INSERT, ASC T&A, CONWAY T&A SINUS, EAR PACK, etc. (see the recall documents for the full list of products)

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98994
Lot/product code:
Medline Kit Number/SKU MNS12180: UDI/DI 10653160327134 (each), 40653160327135 (case), Lot Number 22FBM309; Medline Kit Number/SKU MNS12180: UDI/DI 10653160327134 (each), 40653160327135 (case), Lot Number 22DBJ094; Medline Kit Number/SKU MNS12180: UDI/DI 10653160327134 (each), 40653160327135 (case), Lot Number 22OBH091; Medline Kit Number/SKU MNS12180: UDI/DI 10653160327134 (each), 40653160327135 (case), Lot Number 21HBC428; Medline Kit Number/SKU DYNJ67109B: UDI/DI 10195327207083 (each), 40195327207084 (case), Lot Number 24ABC426; Medline Kit Number/SKU DYNJ67109B: UDI/DI 10195327207083 (each), 40195327207084 (case), Lot Number 23JBM836; Medline Kit Number/SKU DYNJ67109B: UDI/DI 10195327207083 (each), 40195327207084 (case), Lot Number 23HBS357; Medline Kit Number/SKU DYNJ67109B: UDI/DI 10195327207083 (each), 40195327207084 (case), Lot Number 22KBS784; Medline Kit Number/SKU DYNJ67109B: UDI/DI 10195327207083 (each), 40195327207084 (case), Lot Number 22IBV574; Medline Kit Number/SKU DYNJ67109D: UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 26ABH211; Medline Kit Number/SKU DYNJ67109D: UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 25GBS702; Medline Kit Number/SKU DYNJ67109D: UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 25EBT418; Medline Kit Number/SKU DYNJ67109D: UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 24LBP073; Medline Kit Number/SKU DYNJ67109D: UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 24JBI868; Medline Kit Number/SKU DYNJ67109D: UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 24HBW417; Medline Kit Number/SKU DYNJ67109D: UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 24EBV861; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 26CMK753; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 26BMF647; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 26BMB840; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25KMD227; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25JMB620; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25HME486; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25GMA169; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25EME427; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25CMG490; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25BMC915; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25AMD126; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24KMJ170; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24KMA267; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24IMH206; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24HMI841; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24HMA214; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24FMH462; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24EMJ672; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24EME216; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24DMK415; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24CMA079; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24BMG449; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24BMC569; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 23LME699; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 23JMD593; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 23HMI241; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 23HMB780; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 23GMD384; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 23EMB734; Medline Kit Number/SKU PHS41719A: UDI/DI … (truncated, 291828 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND18350

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98994
Lot/product code:
UDI/DI 10080196996759 (each), 40080196996750 (case); ALL LOTS
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 16 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR16C

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98994
Lot/product code:
UDI/DI 10197344149001 (each), 20197344149008 (case); ALL LOTS
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Medical Procedure Kits labeled as: TONSIL PACK CATH, Medline Kit Number/SKU DYNJ65199A

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98994
Lot/product code:
UDI/DI 10195327119751 (each), 40195327119752 (case), Lot Numbers: 23HMI132, 23HMA956 23GMA525, 23DMF610, 23AMH680, 22CBF155.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Number/SKU DYNJ47625B; 2) GYN VAGINAL, Medline Kit Number/SKU DYNJ912219; 3) KIT MAJ VAG SET UP, Medline Kit Number/SKU DYNJ907033B; 4) MINOR VAG PACK, Medline Kit Number/SKU DYNJ68663B; 5) OB DELIVERY PACK, Medline Kit Number/SKU DYNJ14099F; 6) OB DELIVERY PACK, Medline Kit Number/SKU DYNJ14099G; 7) OB PACK, Medline Kit Number/SKU DYNJ03387B; 8) OB PACK, Medline Kit Number/SKU DYNJ03387C; 9) OB PACK, Medline Kit Number/SKU DYNJ53543B; 10) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645D; 11) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645F; 12) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645G; 13) VAGINAL DELIVERY PACK, Medline Kit Number/SKU DYNJ04454K; 14) VAGINAL DELIVERY PACK, Medline Kit Number/SKU DYNJ04454L; 15) VAGINAL PACK, Medline Kit Number/SKU DYNJ01830G.

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98994
Lot/product code:
Medline Kit Number/SKU DYNJ47625B, UDI/DI 10889942182589 (each), 40889942182580 (case), Lot Number 21LBI584; Medline Kit Number/SKU DYNJ912219, UDI/DI 10198459676048 (each), 40198459676049 (case), Lot Number 26BBQ085; Medline Kit Number/SKU DYNJ907033B, UDI/DI 10195327205980 (each), 40195327205981 (case), Lot Number 23BBK437; Medline Kit Number/SKU DYNJ907033B, UDI/DI 10195327205980 (each), 40195327205981 (case), Lot Number 22LBP927; Medline Kit Number/SKU DYNJ907033B, UDI/DI 10195327205980 (each), 40195327205981 (case), Lot Number 22KBA970; Medline Kit Number/SKU DYNJ907033B, UDI/DI 10195327205980 (each), 40195327205981 (case), Lot Number 22JBH943; Medline Kit Number/SKU DYNJ907033B, UDI/DI 10195327205980 (each), 40195327205981 (case), Lot Number 22HBR879; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 25ABD038; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 24IBP599; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 24HBT938; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 24GBB724; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 24DBK110; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 24ABN322; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 23LBB050; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 23KBB963; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 23HBG577; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 23GBV662; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 23FBC135; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 23EBI988; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 23EMG547; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 23DME985; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 23BMA262; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 23AMC310; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 22LMG249; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 22JMG781; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 22HME796; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 22FBW026; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 22DBS732; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 22OBD819; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 22BBR963; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 21JBP278; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 21IBJ988; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 21HBF040; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 21GBE751; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 21DBJ299; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 21CBS171; Medline Kit Number/SKU DYNJ14099F.UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 21BBO974; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 21ABH741; Medline Kit Number/SKU DYNJ14099G, UDI/DI 10195327446635 (each), 40195327446636 (case), Lot Number 24IMB312; Medline Kit Number/SKU DYNJ14099G, UDI/DI 10195327446635 (each), 40195327446636 (case), Lot Number 24HMA611; Medline Kit Number/SKU DYNJ14099G, UDI/DI 10195327446635 (each), 40195327446636 (case), Lot Number 24FMA120; Medline Kit Number/SKU DYNJ14099G, UDI/DI 10195327446635 (each), 40195327446636 (case), Lot Number 24DMG080; Medline Kit Number/SKU DYNJ14099G, UDI/DI 10195327446635 (each), 40195327446636 (case), Lot Number 24CMJ181; Medline Kit Number/SKU DYNJ14099G, UDI/DI 10195327446635 (each), 40195327446636 (case), Lot Number 24CMI617; Medline Kit Number/SKU DYNJ14099G, UDI/DI 10195327446635 (each), 40195327446636 (case), Lot Number 24BMH160; Medline Kit Number/SKU DYNJ14099G, UDI/DI 1019… (truncated, 14302 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/SKU EDUC1044

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98994
Lot/product code:
UDI/DI 10195327449476 (each), 40195327449477 (case), Lot Number 23HDA449
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Medical Procedure Kits labeled as: DR FERNANDEZ, Medline kit number/SKU DYNJ68808

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98994
Lot/product code:
UDI/DI 10193489843187 (each), 40193489843188 (case), Lot Numbers: 21LBT965, 21IBU081, 21GBN159, 21DBC976.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C PACK, D&C HYSTER PACK, FLWR GYN PACK, FS LAP TUBAL LIGATION, HILLSDALE D&C / HYSTEROSCOPY, LAVH NEW BRAUNFELS,TVH PACK, etc (see recall documents for a full list of affected products)

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98994
Lot/product code:
Medline Kit Number/SKU DYNJ61063A: UDI/DI 10193489640458 (each), 40193489640459 (case), Lot Number 21KBV571; Medline Kit Number/SKU DYNJ61063B: UDI/DI 10195327193478 (each), 40195327193479 (case), Lot Number 23EBU351; Medline Kit Number/SKU DYNJ61063B: UDI/DI 10195327193478 (each), 40195327193479 (case), Lot Number 23DBQ190; Medline Kit Number/SKU DYNJ61063B: UDI/DI 10195327193478 (each), 40195327193479 (case), Lot Number 23BBE364; Medline Kit Number/SKU DYNJ61063B: UDI/DI 10195327193478 (each), 40195327193479 (case), Lot Number 22IBW094; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 26CMK666; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 26BMG709; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 26AMI644; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25KMD133; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25JMA568; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25IMF717; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25HMJ595; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25FMH149; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25EME964; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25DMG466; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25CMH227; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25CMC736; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25BMB744; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 24LMB964; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 24JMB516; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 24JMA159; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 24EMI862; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 24DMG741; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 24CBP782; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 24CMI475; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 24BBU531; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 24BBB690; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 23LBH349; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 23JBP275; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 23IBU481; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 23GBW750; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 23GBB691; Medline Kit Number/SKU DYNJ50874C: UDI/DI 10195327024963 (each), 40195327024964 (case), Lot Number 22ABS574; Medline Kit Number/SKU DYNJ50874C: UDI/DI 10195327024963 (each), 40195327024964 (case), Lot Number 22ABI415; Medline Kit Number/SKU DYNJ50874C: UDI/DI 10195327024963 (each), 40195327024964 (case), Lot Number 21KBN568; Medline Kit Number/SKU DYNJ50874D: UDI/DI 10195327165383 (each), 40195327165384 (case), Lot Number 24CBV299; Medline Kit Number/SKU DYNJ50874D: UDI/DI 10195327165383 (each), 40195327165384 (case), Lot Number 24BBQ334; Medline Kit Number/SKU DYNJ50874D: UDI/DI 10195327165383 (each), 40195327165384 (case), Lot Number 24ABY235; Medline Kit Number/SKU DYNJ50874D: UDI/DI 10195327165383 (each), 40195327165384 (case), Lot Number 23KBJ941; Medline Kit Number/SKU DYNJ50874D: UDI/DI 10195327165383 (each), 40195327165384 (case), Lot Number 23IBS067; Medline Kit Number/SKU DYNJ50874D: UDI/DI 10195327165383 (each), 40195327165384 (case), Lot Number 23GBP406; Medline Kit Number/SKU DYNJ50874D: UDI/DI 10195327165383 (each), 40195327165384 (case), Lot Number 23FBQ543; Medline Kit Number/SKU DYNJ50874D: UDI/DI 10195327165383 (each), 40195327165384 (case), Lot Number 23EBS415; Medline Kit Number/SKU DYNJ50874D: UDI/DI 10195327165383 (each), 40195327165384 (case), Lot Number 23CBS427; Medline Kit Number/SKU DYNJ50874D: UDI/DI 10195327165383 (each), 40195327165384 (case), Lot Number 23ABJ828; Medli… (truncated, 86341 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTEROSCOPY, CW LAP GYN, DEACONESS PELVIC LAP PACK, FLOYD LAP GYN, GYN LAP PACK, GYN LAPAROSCOPY, GYN MINOR PACK, etc. (see the recall documents for a full list of affected products)

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98994
Lot/product code:
Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 24GMJ742; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 24FMC978; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 24CMA556; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 24BMI027; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 24AMF247; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 24AMA807; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 23IMF051; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 23HMG141; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 23EMF259; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 23DMA689; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 23CMF097; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 23CMC699; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 22LME333; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 22KMB390; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 22HMC449; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 22GMD678; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 22FMG214; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 22DME100; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 22CME928; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 22BMG698; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 22AMD289; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 21KMD167; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 21JMF926; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 21IMD987; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 21GME755; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 21FBF900; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 21CBF873; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 21ABE015; Medline Kit Number/SKU DYNJ905924D: UDI/DI 10198459256400 (each), 40198459256401 (case), Lot Number 26DME629; Medline Kit Number/SKU DYNJ905924D: UDI/DI 10198459256400 (each), 40198459256401 (case), Lot Number 25LMG110; Medline Kit Number/SKU DYNJ905924D: UDI/DI 10198459256400 (each), 40198459256401 (case), Lot Number 25LMB085; Medline Kit Number/SKU DYNJ905924D: UDI/DI 10198459256400 (each), 40198459256401 (case), Lot Number 25IMH993; Medline Kit Number/SKU DYNJ905924D: UDI/DI 10198459256400 (each), 40198459256401 (case), Lot Number 25EMC711; Medline Kit Number/SKU DYNJ905924D: UDI/DI 10198459256400 (each), 40198459256401 (case), Lot Number 25DMH514; Medline Kit Number/SKU DYNJ905924D: UDI/DI 10198459256400 (each), 40198459256401 (case), Lot Number 25CMD890; Medline Kit Number/SKU DYNJ905924D: UDI/DI 10198459256400 (each), 40198459256401 (case), Lot Number 25CMB602; Medline Kit Number/SKU DYNJ905924C: UDI/DI 10198459076527 (each), 40198459076528 (case), Lot Number 24KMH725; Medline Kit Number/SKU DYNJ905924C: UDI/DI 10198459076527 (each), 40198459076528 (case), Lot Number 24IMG083; Medline Kit Number/SKU DYNJ906047A: UDI/DI 10195327009014 (each), 40195327009015 (case), Lot Number 23ABJ617; Medline Kit Number/SKU DYNJ906047C: UDI/DI 10198459287473 (each), 40198459287474 (case), Lot Number 26DBN259; Medline Kit Number/SKU DYNJ906047C: UDI/DI 10198459287473 (each), 40198459287474 (case), Lot Number 26CBD812; Medline Kit Number/SKU DYNJ906047C: UDI/DI 10198459287473 (each), 40198459287474 (case), Lot Number 25GBK346; Medline Kit Number/SKU DYNJ906047C: UDI/DI 10198459287473 (each), 40198459287474 (case), Lot Number 25DBT775; Medline Kit Number/SKU DYNJ906047C: UDI/DI 10198459287473 (each), 40198459287474 (case), Lot Number 25DBA222; Medline Kit Number/SKU DYNJ901133A: UDI/DI 10888277949683 (each), 40888… (truncated, 76565 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Number/SKU DYNJ47625B; 2) GYN VAGINAL, Medline Kit Number/SKU DYNJ912219; 3) KIT MAJ VAG SET UP, Medline Kit Number/SKU DYNJ907033B; 4) MINOR VAG PACK, Medline Kit Number/SKU DYNJ68663B; 5) OB DELIVERY PACK, Medline Kit Number/SKU DYNJ14099F; 6) OB DELIVERY PACK, Medline Kit Number/SKU DYNJ14099G; 7) OB PACK, Medline Kit Number/SKU DYNJ03387B; 8) OB PACK, Medline Kit Number/SKU DYNJ03387C; 9) OB PACK, Medline Kit Number/SKU DYNJ53543B; 10) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645D; 11) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645F; 12) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645G; 13) VAGINAL DELIVERY PACK, Medline Kit Number/SKU DYNJ04454K; 14) VAGINAL DELIVERY PACK, Medline Kit Number/SKU DYNJ04454L; 15) VAGINAL PACK, Medline Kit Number/SKU DYNJ01830G.

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98994
Lot/product code:
Medline Kit Number/SKU DYNJ47625B, UDI/DI 10889942182589 (each), 40889942182580 (case), Lot Number 21LBI584; Medline Kit Number/SKU DYNJ912219, UDI/DI 10198459676048 (each), 40198459676049 (case), Lot Number 26BBQ085; Medline Kit Number/SKU DYNJ907033B, UDI/DI 10195327205980 (each), 40195327205981 (case), Lot Number 23BBK437; Medline Kit Number/SKU DYNJ907033B, UDI/DI 10195327205980 (each), 40195327205981 (case), Lot Number 22LBP927; Medline Kit Number/SKU DYNJ907033B, UDI/DI 10195327205980 (each), 40195327205981 (case), Lot Number 22KBA970; Medline Kit Number/SKU DYNJ907033B, UDI/DI 10195327205980 (each), 40195327205981 (case), Lot Number 22JBH943; Medline Kit Number/SKU DYNJ907033B, UDI/DI 10195327205980 (each), 40195327205981 (case), Lot Number 22HBR879; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 25ABD038; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 24IBP599; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 24HBT938; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 24GBB724; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 24DBK110; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 24ABN322; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 23LBB050; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 23KBB963; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 23HBG577; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 23GBV662; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 23FBC135; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 23EBI988; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 23EMG547; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 23DME985; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 23BMA262; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 23AMC310; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 22LMG249; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 22JMG781; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 22HME796; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 22FBW026; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 22DBS732; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 22OBD819; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 22BBR963; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 21JBP278; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 21IBJ988; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 21HBF040; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 21GBE751; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 21DBJ299; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 21CBS171; Medline Kit Number/SKU DYNJ14099F.UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 21BBO974; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 21ABH741; Medline Kit Number/SKU DYNJ14099G, UDI/DI 10195327446635 (each), 40195327446636 (case), Lot Number 24IMB312; Medline Kit Number/SKU DYNJ14099G, UDI/DI 10195327446635 (each), 40195327446636 (case), Lot Number 24HMA611; Medline Kit Number/SKU DYNJ14099G, UDI/DI 10195327446635 (each), 40195327446636 (case), Lot Number 24FMA120; Medline Kit Number/SKU DYNJ14099G, UDI/DI 10195327446635 (each), 40195327446636 (case), Lot Number 24DMG080; Medline Kit Number/SKU DYNJ14099G, UDI/DI 10195327446635 (each), 40195327446636 (case), Lot Number 24CMJ181; Medline Kit Number/SKU DYNJ14099G, UDI/DI 10195327446635 (each), 40195327446636 (case), Lot Number 24CMI617; Medline Kit Number/SKU DYNJ14099G, UDI/DI 10195327446635 (each), 40195327446636 (case), Lot Number 24BMH160; Medline Kit Number/SKU DYNJ14099G, UDI/DI 1019… (truncated, 14302 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline Kit Number/SKU DYNJ44926G; 2) VP SHUNT CDS, Medline Kit Number/SKU CDS983800J; 3) VP SHUNT CDS, Medline Kit Number/SKU CDS983800K.

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98994
Lot/product code:
Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 24EBH848; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 24DBK995; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 23JBP023; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 23HBR067; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 23FBM330; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 23EBK061; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 22JBG042; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 22GBH864; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 22DBT571; Medline Kit Number/SKU CDS983800J: UDI/DI 10195327684662 (each), 40195327684663 (case), Lot Number 25DMJ438; Medline Kit Number/SKU CDS983800J: UDI/DI 10195327684662 (each), 40195327684663 (case), Lot Number 25CMH178; Medline Kit Number/SKU CDS983800J: UDI/DI 10195327684662 (each), 40195327684663 (case), Lot Number 24IME720; Medline Kit Number/SKU CDS983800J: UDI/DI 10195327684662 (each), 40195327684663 (case), Lot Number 24HMG912; Medline Kit Number/SKU CDS983800K: UDI/DI 10198459518973 (each), 40198459518974 (case), Lot Number 26CMC503; Medline Kit Number/SKU CDS983800K: UDI/DI 10198459518973 (each), 40198459518974 (case), Lot Number 26AMB047; Medline Kit Number/SKU CDS983800K: UDI/DI 10198459518973 (each), 40198459518974 (case), Lot Number 25JME109.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483A; 2) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483B; 3) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483C; 4) CV DRAPING/BASIN 2PART PACK, Medline Kit Number/SKU DYNJ89414; 5) CVG BASIN PACK SC, Medline Kit Number/SKU DYNJ38052G; 6) T/A BASIN SET, Medline Kit Number/SKU DYNJ47941F; 7) VALVE BASIN PACK SC, Medline Kit Number/SKU DYNJ38054G.

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98994
Lot/product code:
Medline Kit Number/SKU DYNJ908483A: UDI/DI 10195327191887, (each) 40195327191888, (case), Lot Number 22HMA818; Medline Kit Number/SKU DYNJ908483A: UDI/DI 10195327191887, (each) 40195327191888, (case), Lot Number 22GMG188; Medline Kit Number/SKU DYNJ908483B: UDI/DI 10195327287764, (each) 40195327287765, (case), Lot Number 23FMB021; Medline Kit Number/SKU DYNJ908483B: UDI/DI 10195327287764, (each) 40195327287765, (case), Lot Number 23CMB395; Medline Kit Number/SKU DYNJ908483B: UDI/DI 10195327287764, (each) 40195327287765, (case), Lot Number 23BMF105; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 25BMG115; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24KMG981; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24KMG043; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24KME988; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24JMC883; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24HMG291; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24GMG957; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24GMC708; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24EMD960; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24EMD976; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24CMC199; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 23LMH271; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 23LMC861; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 23JMI184; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 23JMC583; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 23IMH859; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 23HME147; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 23HMB823; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 23GMD479; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 23FMH321; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 23FME722; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24EMC843; Medline Kit Number/SKU DYNJ89414: UDI/DI 10198459272127, (each) 40198459272128, (case), Lot Number 26CME546; Medline Kit Number/SKU DYNJ89414: UDI/DI 10198459272127, (each) 40198459272128, (case), Lot Number 26AMD910; Medline Kit Number/SKU DYNJ89414: UDI/DI 10198459272127, (each) 40198459272128, (case), Lot Number 25KMF065; Medline Kit Number/SKU DYNJ89414: UDI/DI 10198459272127, (each) 40198459272128, (case), Lot Number 25IMI592; Medline Kit Number/SKU DYNJ89414: UDI/DI 10198459272127, (each) 40198459272128, (case), Lot Number 25HMB017A; Medline Kit Number/SKU DYNJ89414: UDI/DI 10198459272127, (each) 40198459272128, (case), Lot Number 25HMB017; Medline Kit Number/SKU DYNJ89414: UDI/DI 10198459272127, (each) 40198459272128, (case), Lot Number 25GMK081; Medline Kit Number/SKU DYNJ89414: UDI/DI 10198459272127, (each) 40198459272128, (case), Lot Number 25DMI874; Medline Kit Number/SKU DYNJ89414: UDI/DI 10198459272127, (each) 40198459272128, (case), Lot Number 25BME130; Medline Kit Number/SKU DYNJ38052G: UDI/DI 10195327100131, (each) 40195327100132, (case), Lot Number 24CBE682; Medline Kit Number/SKU DYNJ38052G: UDI/DI 10195327100131, (each) 40195327100132, (case), Lot Number 23LBN771; Medline Kit Number/SKU DYNJ38052G: UDI/DI 10195327100131, (each) 40195327100132, (case), Lot Number 23LBJ194; Medline Kit Number/SKU DYNJ38052G: UDI/DI 10195327100131, (each) 40195327100132, (case), Lot Number 23KBO599; Medline Kit Number/SKU DYNJ38052G: UDI/DI 10195327100131, (each) 40195327100132, (case), Lot Number 23FBO284; Medline Kit Number/SKU DYNJ38052G: UDI/DI 10195327100131, (each) 40195327100132, (case), Lot Number 23EBM695; Medline Kit Number/SKU DYNJ38052G: UDI/DI 10195327100131, (each) 40195327100132, (case), Lot Number 22IBP839; Medline Kit Number/SKU DYNJ38052G: UDI/DI 10195327100131, (each) 40195327100132, (case), Lot Number 22GBU984; Medline Kit Number/SKU DYNJ38052G: UDI/DI 1019532710… (truncated, 6737 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline Kit Number/SKU DYNJ44926G; 2) VP SHUNT CDS, Medline Kit Number/SKU CDS983800J; 3) VP SHUNT CDS, Medline Kit Number/SKU CDS983800K.

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98994
Lot/product code:
Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 24EBH848; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 24DBK995; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 23JBP023; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 23HBR067; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 23FBM330; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 23EBK061; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 22JBG042; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 22GBH864; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 22DBT571; Medline Kit Number/SKU CDS983800J: UDI/DI 10195327684662 (each), 40195327684663 (case), Lot Number 25DMJ438; Medline Kit Number/SKU CDS983800J: UDI/DI 10195327684662 (each), 40195327684663 (case), Lot Number 25CMH178; Medline Kit Number/SKU CDS983800J: UDI/DI 10195327684662 (each), 40195327684663 (case), Lot Number 24IME720; Medline Kit Number/SKU CDS983800J: UDI/DI 10195327684662 (each), 40195327684663 (case), Lot Number 24HMG912; Medline Kit Number/SKU CDS983800K: UDI/DI 10198459518973 (each), 40198459518974 (case), Lot Number 26CMC503; Medline Kit Number/SKU CDS983800K: UDI/DI 10198459518973 (each), 40198459518974 (case), Lot Number 26AMB047; Medline Kit Number/SKU CDS983800K: UDI/DI 10198459518973 (each), 40198459518974 (case), Lot Number 25JME109.
Recalling firm:
Medline Industries, LP
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