BIGNOPE
Ko-fi

Recalls affecting Northern Mariana Islands

Data last updated: September 10, 2026 at 1:16 PM UTC

15,877 recalls found
NewOld
High RiskLow Risk
AllClear

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/virusSalmonellaAnnounced 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/virusE. coliAnnounced 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)
UnclassifiedAllergenMilkUndeclaredAnnounced 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)
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)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced 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/virusSalmonellaAnnounced 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)
Wording
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: PELVIC LAP PACK, Medline Kit Number/ SKU DYNJ53820B

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 10195327548261 (each), 40195327548262 (case). Lot Numbers: 25LBI062, 25HBR967, 24JBK618, 24BBQ860.
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: 1) D AND C PACK, Medline Kit Number/SKU DYNJ53973C; 2) PK CUST CV A&B CABRINI CO, Medline Kit Number/SKU DYNJ60583C.

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 Product Number/SKU DYNJ53973C: UDI/DI 10195327008864 (each), 40195327008865 (case), Lot Number 21KME435; Medline Product Number/SKU DYNJ53973C: UDI/DI 10195327008864 (each), 40195327008865 (case), Lot Number 21JMC247; Medline Product Number/SKU DYNJ53973C: UDI/DI 10195327008864 (each), 40195327008865 (case), Lot Number 21JMB678; Medline Product Number/SKU DYNJ53973C: UDI/DI 10195327008864 (each), 40195327008865 (case), Lot Number 21IMH919; Medline Product Number/SKU DYNJ60583C: UDI/DI 10195327605582 (each), 40195327605583 (case), Lot Number 24CBO389; Medline Product Number/SKU DYNJ60583C: UDI/DI 10195327605582 (each), 40195327605583 (case), Lot Number 24ABR872.
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 Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYND13508 - 08 Fr; 2. DYND13510 - 10 Fr; 3. DYND13512 - 12 Fr; 4. DYND13514 - 14 Fr; 5. DYND13515 - 15 Fr; 6. DYND13516 - 16 Fr; 7. DYND13518 - 18 Fr; 8. DYND13520 - 20 Fr; 9. DYND13522 - 22 Fr; 10. DYND13614 - 14 Fr; 11. DYND13616 - 16 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. DYND13508, UDI/DI 10080196031139 (each), 20080196031136 (case); 2. DYND13510, UDI/DI 10080196726462 (each), 40080196726463 (case); 3. DYND13512, UDI/DI 10080196031177 (each), 40080196031178 (case); 4. DYND13514, UDI/DI 10080196726219 (each), 40080196726210 (case); 5. DYND13515, UDI/DI 10080196031214 (each), 40080196031215 (case); 6. DYND13516, UDI/DI 10080196031221 (each), 40080196031222 (case); 7. DYND13518, UDI/DI 10080196031245 (each), 40080196031246 (case); 8. DYND13520, UDI/DI 10080196031252 (each), 40080196031253 (case); 9. DYND13522, UDI/DI 10080196061259 (each), 40080196061250 (case); 10. DYND13614, UDI/DI 10080196031276 (each), 30080196031270 (case); 11. DYND13616, UDI/DI 10888277720879 (each), 20888277720876 (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 BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the 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 BIOB686: UDI/DI 10193489684025 (each), 40193489684026 (case), Lot Number 22CMD618; Medline Kit Number/SKU DYNJ83242: UDI/DI 10195327242398 (each), 40195327242399 (case), Lot Number 23BBK690; Medline Kit Number/SKU DYNJ83242: UDI/DI 10195327242398 (each), 40195327242399 (case), Lot Number 23ABK356; Medline Kit Number/SKU DYNJ83242: UDI/DI 10195327242398 (each), 40195327242399 (case), Lot Number 23ABG037; Medline Kit Number/SKU DYNJ83242: UDI/DI 10195327242398 (each), 40195327242399 (case), Lot Number 22IBL708; Medline Kit Number/SKU DYNJ83242A: UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 24GBK706; Medline Kit Number/SKU DYNJ83242A: UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 24GBH415; Medline Kit Number/SKU DYNJ83242A: UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 24FBQ282; Medline Kit Number/SKU DYNJ83242A: UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 24FBC513; Medline Kit Number/SKU DYNJ83242A: UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 23KBK097; Medline Kit Number/SKU DYNJ83242A: UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 23DBF286; Medline Kit Number/SKU DYNJ83242A: UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 23CBI425; Medline Kit Number/SKU DYNJ83242C: UDI/DI 10198459575655 (each), 40198459575656 (case), Lot Number 26DBE336; Medline Kit Number/SKU DYNJ67486A: UDI/DI 10193489888768 (each), 40193489888769 (case), Lot Number 22ABR834; Medline Kit Number/SKU DYNJ67486A: UDI/DI 10193489888768 (each), 40193489888769 (case), Lot Number 21HBL801; Medline Kit Number/SKU DYNJ67486A: UDI/DI 10193489888768 (each), 40193489888769 (case), Lot Number 21FBK710; Medline Kit Number/SKU DYNJ14052D: UDI/DI 10888277538689 (each), 40888277538680 (case), Lot Number 24ABS522; Medline Kit Number/SKU DYNJ14052D: UDI/DI 10888277538689 (each), 40888277538680 (case), Lot Number 23HBB533; Medline Kit Number/SKU DYNJ14052D: UDI/DI 10888277538689 (each), 40888277538680 (case), Lot Number 23BBD374; Medline Kit Number/SKU DYNJ14052D: UDI/DI 10888277538689 (each), 40888277538680 (case), Lot Number 22HBN112; Medline Kit Number/SKU DYNJ14052D: UDI/DI 10888277538689 (each), 40888277538680 (case), Lot Number 22OBA524; Medline Kit Number/SKU DYNJ14052D: UDI/DI 10888277538689 (each), 40888277538680 (case), Lot Number 21JBN396; Medline Kit Number/SKU DYNJ14052D: UDI/DI 10888277538689 (each), 40888277538680 (case), Lot Number 21ABG632; Medline Kit Number/SKU DYNJ14052F: UDI/DI 10195327659646 (each), 40195327659647 (case), Lot Number 25CBE701; Medline Kit Number/SKU DYNJ14052F: UDI/DI 10195327659646 (each), 40195327659647 (case), Lot Number 24HBD087; Medline Kit Number/SKU DYNJ14052F: UDI/DI 10195327659646 (each), 40195327659647 (case), Lot Number 24GBW446; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 23JBH039; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 23GBK315; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 23FBF483; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 23EBC641; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 23CBF936; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 23ABJ282; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 22HBL398; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 22GBI901; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 22FBB507; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 21LBT981; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 21KBR323; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 21JBB953; Medline Kit Number/SKU DYNJ14053F: UDI/DI 10195327557324 (each), 40195327557325 (case), Lot Number 24BBF579; Medline Kit Number/SKU DYNJ14053F: UDI/DI 10195327557324 (each), 40195327557325 (case), Lot Number 24ABF455; Medline Kit Number/SKU DYNJ14053F: UDI/DI 10195327557324 (each), 40195327557325 (case), Lot Number 23KBJ248; Medline Kit Number/SKU DYNJ14053G: UDI/DI 10195327659691 (each), 40195327659692 (case), Lot Number 25HBQ577; Medline Kit Number/SKU DYNJ14053G: UDI/DI 10195327659691 (each), 40195327659692 (case), Lot Number 25FBR065; Medline Kit Number/SKU DYNJ14053G: UDI/DI 10195327659691 (each), 40195327659692 (case), Lot Number 25BBO494; Medline Kit Number/SKU DYNJ14053G: UDI/DI 10195327659691 (each), 401953276596… (truncated, 259986 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: 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: 1) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU DYKMBNDL117C; 2) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978; 3) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978F.

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 DYKMBNDL117C: UDI/DI 10195327371104 (each), 40195327371105 (case), Lot Number 23DLA834; Medline Kit Number/SKU DYNJ908978: UDI/DI 10195327231132 (each), 40195327231133 (case), Lot Number 23BMC463; Medline Kit Number/SKU DYNJ908978: UDI/DI 10195327231132 (each), 40195327231133 (case), Lot Number 23AMA685; Medline Kit Number/SKU DYNJ908978: UDI/DI 10195327231132 (each), 40195327231133 (case), Lot Number 23AMB905; Medline Kit Number/SKU DYNJ908978: UDI/DI 10195327231132 (each), 40195327231133 (case), Lot Number 22LMG466; Medline Kit Number/SKU DYNJ908978: UDI/DI 10195327231132 (each), 40195327231133 (case), Lot Number 22LMB983; Medline Kit Number/SKU DYNJ908978F: UDI/DI 10198459228803 (each), 40198459228804 (case), Lot Number 25JBD225; Medline Kit Number/SKU DYNJ908978F: UDI/DI 10198459228803 (each), 40198459228804 (case), Lot Number 25HBW236.
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: LAPAROSCOPY COMBINED - NO NDL, Medline Kit Number/SKU DYNJ37378A

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 10889942113583 (each), 40889942113584 (case); Lot Numbers: DYNJ37378A, DYNJ37378A, DYNJ37378A.
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: 1) CHEST EXPLORATION ECMO, Medline Kit Number/SKU DYNJ63789A; 2) CORONARY/ARTERY BYPASS TRAY, Medline Kit Number/SKU DYNJ17321G; 3) D&C/CYSTO, Medline Kit Number/SKU DYNJ909989B; 4) DDD LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ53214; 5) DIAGNOSTIC LAPAROSCOPY, Medline Kit Number/SKU DYNJ903390K; 6) GENERAL LAPAROSCOPY, Medline Kit Number/SKU DYNJ902700C; 7) GENERAL LAPAROSCOPY, Medline Kit Number/SKU DYNJ902700D; 8) GENERAL LAPAROSCOPY, Medline Kit Number/SKU DYNJ902700F; 9) GENERAL-CVOR MINOR, Medline Kit Number/SKU DYNJ64324A; 10) GYN LAP, Medline Kit Number/SKU DYNJT7061; 11) GYN LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ53631F; 12) GYN MINOR PACK, Medline Kit Number/SKU DYNJ85910; 13) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU DYKMBNDL117A; 14) LAP, Medline Kit Number/SKU DYNJ904585B; 15) LAP, Medline Kit Number/SKU DYNJ904585C; 16) LAP CHOLE CDS, Medline Kit Number/SKU CDS983255R; 17) LAP CHOLE CDS, Medline Kit Number/SKU CDS983255S; 18) LAP CHOLE CDS, Medline Kit Number/SKU CDS983255T; 19) LAPAROSCOPY, Medline Kit Number/SKU DYNJ89908; 20) LAPAROSCOPY, Medline Kit Number/SKU DYNJ910517; 21) LAPAROSCOPY, Medline Kit Number/SKU DYNJ910517A; 22) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ06958I; 23) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ06958J; 24) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ53992C; 25) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ53992D; 26) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ53992F; 27) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ53992G; 28) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ53992I; 29) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ67160; 30) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ84211; 31) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJHS0235C; 32) LAPAROSCOPY PACK VICTORY, Medline Kit Number/SKU DYNJ81148; 33) LAPAROSCOPY PK, Medline Kit Number/SKU DYNJ14073B; 34) LAPAROSCOPY PK, Medline Kit Number/SKU DYNJ61404A; 35) LAPAROSCOPY PK, Medline Kit Number/SKU DYNJ61404B; 36) LAPAROSCOPY PK, Medline Kit Number/SKU DYNJ61404C; 37) LAPAROSCOPY PK, Medline Kit Number/SKU DYNJ61404D; 38) LAPAROSCOPY/GYN PACK, Medline Kit Number/SKU DYNJ0384702U; 39) PACK LAPAROSCOPY, Medline Kit Number/SKU DYNJ0553254O; 40) PROCEDURE PACK DR BILIMORI, Medline Kit Number/SKU DYNJ908046A; 41) PROCEDURE PACK DR BILIMORI, Medline Kit Number/SKU DYNJ908046B; 42) PROCEDURE PACK DR BILIMORI, Medline Kit Number/SKU DYNJ908046C; 43) PROCEDURE PACK DR BILIMORI, Medline Kit Number/SKU DYNJ908046D; 44) PROCEDURE PACK DR BILIMORI, Medline Kit Number/SKU DYNJ908046F; 45) PROLAPSE PACK, Medline Kit Number/SKU DYNJ85390; 46) RICH CYSTO, Medline Kit Number/SKU DYNJ902183I; 47) RR-PEDS CHEST BLEEDER/ECMO PK, Medline Kit Number/SKU DYNJ66263B; 48) RR-PEDS CHEST BLEEDER/ECMO PK, Medline Kit Number/SKU DYNJ66263C; 49) SMJ LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ25763J; 50) WCH GENERAL LAPAROSCOPY, Medline Kit Number/SKU DYNJ902700G.

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:
DYNJ63789A: UDI/DI 10198459149771 (each), 40198459149772 (case), Lot Number 26BBD116; DYNJ63789A: UDI/DI 10198459149771 (each), 40198459149772 (case), Lot Number 26ABL500; DYNJ63789A: UDI/DI 10198459149771 (each), 40198459149772 (case), Lot Number 25FBH410; DYNJ63789A: UDI/DI 10198459149771 (each), 40198459149772 (case), Lot Number 25EBQ051; DYNJ63789A: UDI/DI 10198459149771 (each), 40198459149772 (case), Lot Number 25DBS969; DYNJ63789A: UDI/DI 10198459149771 (each), 40198459149772 (case), Lot Number 24LBQ812; DYNJ63789A: UDI/DI 10198459149771 (each), 40198459149772 (case), Lot Number 24LBF658; DYNJ63789A: UDI/DI 10198459149771 (each), 40198459149772 (case), Lot Number 24JBM406; DYNJ17321G: UDI/DI 10193489323863 (each), 40193489323864 (case), Lot Number 23GBM492; DYNJ17321G: UDI/DI 10193489323863 (each), 40193489323864 (case), Lot Number 22IBV269; DYNJ17321G: UDI/DI 10193489323863 (each), 40193489323864 (case), Lot Number 22HBV981; DYNJ17321G: UDI/DI 10193489323863 (each), 40193489323864 (case), Lot Number 22HBF916; DYNJ909989B: UDI/DI 10198459322686 (each), 40198459322687 (case), Lot Number 25GBW197; DYNJ909989B: UDI/DI 10198459322686 (each), 40198459322687 (case), Lot Number 25GBD634; DYNJ909989B: UDI/DI 10198459322686 (each), 40198459322687 (case), Lot Number 25FBB533; DYNJ909989B: UDI/DI 10198459322686 (each), 40198459322687 (case), Lot Number 25EBC752; DYNJ53214: UDI/DI 10889942388301 (each), 40889942388302 (case), Lot Number 21HMG546; DYNJ53214: UDI/DI 10889942388301 (each), 40889942388302 (case), Lot Number 21HMC179; DYNJ903390K: UDI/DI 10198459522826 (each), 40198459522827 (case), Lot Number 26ABQ562; DYNJ903390K: UDI/DI 10198459522826 (each), 40198459522827 (case), Lot Number 25JBB643; DYNJ902700C: UDI/DI 10889942253876 (each), 40889942253877 (case), Lot Number 21EBL762; DYNJ902700D: UDI/DI 10193489906066 (each), 40193489906067 (case), Lot Number 23GBH673; DYNJ902700D: UDI/DI 10193489906066 (each), 40193489906067 (case), Lot Number 23GBH781; DYNJ902700D: UDI/DI 10193489906066 (each), 40193489906067 (case), Lot Number 23DBI173; DYNJ902700D: UDI/DI 10193489906066 (each), 40193489906067 (case), Lot Number 23DBJ926; DYNJ902700D: UDI/DI 10193489906066 (each), 40193489906067 (case), Lot Number 23BBG583; DYNJ902700D: UDI/DI 10193489906066 (each), 40193489906067 (case), Lot Number 23ABT448; DYNJ902700D: UDI/DI 10193489906066 (each), 40193489906067 (case), Lot Number 21IBA024; DYNJ902700D: UDI/DI 10193489906066 (each), 40193489906067 (case), Lot Number 21IBA023; DYNJ902700F: UDI/DI 10195327474362 (each), 40195327474363 (case), Lot Number 24BBP837; DYNJ902700F: UDI/DI 10195327474362 (each), 40195327474363 (case), Lot Number 24BBP021; DYNJ902700F: UDI/DI 10195327474362 (each), 40195327474363 (case), Lot Number 23LBL539; DYNJ64324A: UDI/DI 10195327629632 (each), 40195327629633 (case), Lot Number 25FBC637; DYNJ64324A: UDI/DI 10195327629632 (each), 40195327629633 (case), Lot Number 25EBF271; DYNJ64324A: UDI/DI 10195327629632 (each), 40195327629633 (case), Lot Number 25CBK107; DYNJ64324A: UDI/DI 10195327629632 (each), 40195327629633 (case), Lot Number 24GBH161; DYNJ64324A: UDI/DI 10195327629632 (each), 40195327629633 (case), Lot Number 24BBQ307; DYNJT7061: UDI/DI 10198459594816 (each), 40198459594817 (case), Lot Number 25LBJ399; DYNJ53631F: UDI/DI 10193489293234 (each), 40193489293235 (case), Lot Number 22CBU291; DYNJ53631F: UDI/DI 10193489293234 (each), 40193489293235 (case), Lot Number 22BBB868; DYNJ53631F: UDI/DI 10193489293234 (each), 40193489293235 (case), Lot Number 21LBW055; DYNJ53631F: UDI/DI 10193489293234 (each), 40193489293235 (case), Lot Number 21IBQ254; DYNJ53631F: UDI/DI 10193489293234 (each), 40193489293235 (case), Lot Number 21EBR254; DYNJ53631F: UDI/DI 10193489293234 (each), 40193489293235 (case), Lot Number 21DBO515; DYNJ53631F: UDI/DI 10193489293234 (each), 40193489293235 (case), Lot Number 21DBE409; DYNJ53631F: UDI/DI 10193489293234 (each), 40193489293235 (case), Lot Number 21BBM589; DYNJ85910: UDI/DI 10195327569181 (each), 40195327569182 (case), Lot Number 24FMB929A; DYNJ85910: UDI/DI 10195327569181 (each), 40195327569182 (case), Lot Number 24FMB929; DYNJ85910: UDI/DI 10195327569181 (each), 40195327569182 (case), Lot Number 24DME859; DYNJ85910: UDI/DI 10195327569181 (each), 40195327569182 (case), Lot Number 24BMK071; DYNJ85910: UDI/DI 10195327569181 (each), 40195327569182 (case), Lot Number 24BMD100; DYKMBNDL117A: UDI/DI 10193489882773 (each), 40193489882774 (case), Lot Number 22ELA421; DYKMBNDL117A: UDI/DI 10193489882773 (each), 40193489882774 (case), Lot Number 22ALA614; DYKMBNDL117A: UDI/DI 10193489882773 (each), 40193489882774 (case), Lot Number 22BLB033; DYNJ904585B: UDI/DI 10889942793082 (each), 40889942793083 (case), Lot Number 21KBD965; DYNJ904585B: UDI/DI 10889942793082 (each), 40889942793083 (case), Lot Number 21JBH232; DYNJ904585B: UDI/DI 10889942793082 (each), 408899427… (truncated, 26923 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) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU DYKMBNDL117C; 2) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978; 3) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978F.

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 DYKMBNDL117C: UDI/DI 10195327371104 (each), 40195327371105 (case), Lot Number 23DLA834; Medline Kit Number/SKU DYNJ908978: UDI/DI 10195327231132 (each), 40195327231133 (case), Lot Number 23BMC463; Medline Kit Number/SKU DYNJ908978: UDI/DI 10195327231132 (each), 40195327231133 (case), Lot Number 23AMA685; Medline Kit Number/SKU DYNJ908978: UDI/DI 10195327231132 (each), 40195327231133 (case), Lot Number 23AMB905; Medline Kit Number/SKU DYNJ908978: UDI/DI 10195327231132 (each), 40195327231133 (case), Lot Number 22LMG466; Medline Kit Number/SKU DYNJ908978: UDI/DI 10195327231132 (each), 40195327231133 (case), Lot Number 22LMB983; Medline Kit Number/SKU DYNJ908978F: UDI/DI 10198459228803 (each), 40198459228804 (case), Lot Number 25JBD225; Medline Kit Number/SKU DYNJ908978F: UDI/DI 10198459228803 (each), 40198459228804 (case), Lot Number 25HBW236.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled May 1, 2026

Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

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-0537-2026
Lot/product code:
Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027
Recalling firm:
Amerisource Health Services LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodAllergenUndeclaredRecalled May 1, 2026

SECOND NATURE KETO CRUNCH SMART MIX, 10-ounce retail-sized plastic pouch, UPC 077034013405, 6-10oz units per case.

The product may contain not listed on the label allergens (cashews, pistachios), and dried cherries.

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
H-0905-2026
Lot/product code:
Best if Used By: 2/12/2027
Recalling firm:
SECOND NATURE BRAND
Resolved:
August 21, 2026
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2026

Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840

Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

ALL 50 STATES
▸Full report

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

Recall #:
98922
Lot/product code:
UDI: 07290120281707; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
Recalling firm:
INSPIREMD Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2026

CGuard Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040

Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

ALL 50 STATES
▸Full report

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

Recall #:
98922
Lot/product code:
UDI: 07290120281783; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
Recalling firm:
INSPIREMD Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2026

CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030

Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

ALL 50 STATES
▸Full report

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

Recall #:
98922
Lot/product code:
UDI: 07290120281776; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
Recalling firm:
INSPIREMD Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2026

CGuard Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040

Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

ALL 50 STATES
▸Full report

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

Recall #:
98922
Lot/product code:
UDI: 07290120281783; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
Recalling firm:
INSPIREMD Inc
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled May 1, 2026

Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

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-0536-2026
Lot/product code:
Lot#: 1027583, Exp 09/30/2027
Recalling firm:
Amerisource Health Services LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2026

Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500

GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.

ALL 50 STATES
▸Full report

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

Recall #:
98986
Lot/product code:
Serial Numbers: 5452896 801057486 800977619 801093759 5584569 5587625 5367527 5603110 5371240 5497382
Recalling firm:
GE Medical Systems, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2026

CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930

Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

ALL 50 STATES
▸Full report

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

Recall #:
98922
Lot/product code:
UDI: 07290120281738; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
Recalling firm:
INSPIREMD Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2026

Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830

Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

ALL 50 STATES
▸Full report

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

Recall #:
98922
Lot/product code:
UDI: 07290120281691; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
Recalling firm:
INSPIREMD Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2026

Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models

GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.

ALL 50 STATES
▸Full report

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

Recall #:
98986
Lot/product code:
Serial Numbers: HDGP50034 HDGP51018 HDGS50069 HDGS50070 HDGS50074 HDGS50077 HDGS50158 HDGS50162 HDGS52245 HDGS52286 HDGT50374 HDGT50399 HDGS50464 HDGS50560 HDGS50569 HDGS50570 HDGD50349 HDGG54079 HDGJ50278 HDGJ50281 HDGJ50390 HDGJ50391 HDGJ50394 HDGJ50400 HDGK52363 HDGM50481 HDGM50482 HDGM50483 HDGM50484 HDGM50485 HDGM50486 HDGQ50625 HDGQ50626 HDGQ50627 HDGQ50628 HDGQ50629 HDGS50369 HDGS50370 HDGS50371 HDGS50372 HDGR50086 HDGL51597 HDGG54268 HDGG54270 HDGG54410 HDGK51696 HDGL51002 HDGL51003 HDGL51004 HDGL51005 HDGL51032 HDGN50383 HDGP50522 HDGQ50763 HDGQ50882 HDGQ50884 HDGQ50886 HDGQ50887 HDGQ50901 HDGQ50902 HDGQ50903 HDGQ50904 HDGQ50905 HDGQ50906 HDGQ50907 HDGQ50908 HDGQ50909 HDGQ50910 HDGQ50911 HDGQ50912 HDGQ50913 HDGQ50917 HDGS51833 HDGU60609 HDGU60732 HDGE50297 HDGE50370 HDGE50371 HDGK51791 HDGK51792 HDGK51793 HDGK51794 HDGK51795 HDGK51804 HDGK51822 HDGK51840 HDGR50087 HDGR50088 HDGR50178 HDGR50180 HDGR50184 HDGR50185 HDGN50863 HDGN50864 HDGN50865 HDGN50866 HDGN50868 HDGN50869 HDGN50870 HDGH60335 HDGH60316 HDGH60319 HDGH60320 HDGH60321 HDGH60322 HDGH60323 HDGH60324 HDGH60326 HDGH60327 HDGH60328 HDGH60329 HDGH60330 HDGH60331 HDGH60333 HDGH60334 HDGH60403 HDGH60407 HDGH60408 HDGH60409 HDGN50867 HDGT50420 HDGK51412 HDGK51706 HDGK52164 HDGL50039 HDGL51294 HDGL51483 HDGL51486 HDGM51574 HDGM51575 HDGM51583 HDGP51029 HDGS52343 HDGS52358 HDGJ50055 HDGN50393 HDGM50726 HDGM50093 HDGM50146 HDGM50149 HDGM50151 HDGP51237 HDGP51290 HDGP51297 HDGQ51823 HDGQ51947 HDGJ51132 HDGJ51133 HDGJ51134 HDGJ51136 HDGJ51142 HDGJ51176 HDGJ51177 HDGJ51180 HDGJ51181 HDGJ51182 HDGJ51189 HDGJ51190 HDGL50080 HDGL50082 HDGL50123 HDGL50165 HDGR52333 HDGS50800 HDGS50812 HDGU60084 HDGU60087 HDGU60098 HDGU60157 HDGU60158 HDGU60162 HDGU60168 HDGU60598 HDGT50753 HDGT50754 HDGT50756 HDGT50757 HDGU60516 HDGU60520 HDGU60523 HDGU60527 HDGU60528 HDGU60533 HDGU60535 HDGU60540 HDGU60542 HDGU60543 HDGJ51045 HDGJ51079 HDGQ50791 HDGR52718 HDGR52936 HDGL51165 HDGL51190 HDGM51272 HDGM51289 HDGN51296 HDGN51337 HDGP50832 HDGP50839 HDGT50381 HDGT50382 HDGL51672 HDGN51051 HDGN51096 HDGR50127 HDGR50143 HDGS50619 HDGS50624 HDGS50629 HDGS50630 HDGG55016 HDGJ50424 HDGJ50427 HDGJ50432 HDGK52226 HDGM50995 HDGM50996 HDGM51000 HDGM51003 HDGM51005 HDGM51009 HDGQ50958 HDGQ50961 HDGQ50963 HDGQ50965 HDGQ50967 HDGR52148 HDGR52150 HDGR52152 HDGR52221 HDGR52246 HDGR52281 HDGR52301 HDGR52310 HDGR52329 HDGR52331 HDGD00113 HDGF50369 HDGF53069 HDGF53072 HDGG55175 HDGH60780 HDGH60781 HDGJ50183 HDGJ50935 HDGJ51027 HDGK51849 HDGM50511 HDGQ51811 HDGS50516 HDGT60443 HDGT60444 HDGT60445 HDGK52275 HDGM50360 HDGM50366 HDGM50374 HDGM50397 HDGM50402 HDGM50416 HDGM50417 HDGM50430 HDGM50438 HDGM50439 HDGM50441 HDGM50448 HDGM50455 HDGM50456 HDGM50473 HDGM50548 HDGM50550 HDGM50552 HDGM50553 HDGM50554 HDGM50555 HDGM50557 HDGM50562 HDGM50564 HDGM50581 HDGM50583 HDGM50595 HDGM50632 HDGM50633 HDGM50634 HDGM50635 HDGM50641 HDGM50642 HDGM50646 HDGM50648 HDGM50649 HDGM50650 HDGM50681 HDGM50686 HDGS52298 HDGM50445 HDGM50643 HDGL50363 HDGL51839 HDGK51331 HDGK51348 HDGL51846 HDGL51847 HDGQ51109 HDGQ51112 HDGQ51116 HDGQ51117 HDGS50785 HDGS50787 HDGS52365 HDGS52369 HDGT60089 HDGT60113 HDGL50427 HDGL50628 HDGS50005 HDGS50010 HDGN50437 HDGN50586 HDGN50588 HDGN50590 HDGN50591 HDGN50592 HDGN50593 HDGN50594 HDGN50606 HDGN50793 HDGG54096 HDGG54099 HDGG54100 HDGL51851 HDGL51857 HDGL51858 HDGP50025 HDGQ51891 HDGT50691 HDGM50788 HDGM50789 HDGN50790 HDGH61006 HDGS50355 HDGS50755 HDGH60898 HDGE50352 HDGJ50127 HDGJ50133 HDGJ50393 HDGJ50396 HDGJ50397 HDGJ50399 HDGJ50401 HDGJ50404 HDGJ50405 HDGT50740 HDGJ50654 HDGJ50657 HDGG54196 HDGH60133 HDGH60485 HDGH60505 HDGH60571 HDGJ50175 HDGK51252 HDGK51350 HDGS51933 HDGS51974 HDGS52066 HDGS52088 HDGS52149 HDGS52151 HDGK51230 HDGK51232 HDGK52080 HDGK52081 HDGK52189 HDGK52190 HDGK52194 HDGK52195 HDGK52263 HDGN51268 HDGN51306 HDGN51308 HDGJ51212 HDGL51827 HDGM51259 HDGM51356 HDGM51360 HDGN50309 HDGP50101 HDGU60725 HDGU60731 HDGU60735 HDGU60840 HDGU60863 HDGU60881 HDGU63034 HDGU63201 HDGU63220 HDGU63222 HDGQ50008 HDGQ50079 HDGU60441 HDGM52234 HDGN50198 HDGP50027 HDGP50031 HDGP50032 HDGP50048 HDGP50050 HDGP50053 HDGP50055 HDGP50057 HDGP50073 HDGP50075 HDGP50077 HDGP50083 HDGP50084 HDGP50087 HDGP50089 HDGP50092 HDGP50110 HDGP50111 HDGP50112 HDGP50114 HDGP50115 HDGP50118 HDGP50122 HDGP50127 HDGL51643 HDGL51802 HDGM50104 HDGM50131 HDGM50133 HDGM50137 HDGM50138 HDGM50139 HDGM50140 HDGM50142 HDGM50143 HDGM50144 HDGS50191 HDGS50200 HDGS50780 HDGT50540 HDGK52422 HDGK52604 HDGL50012 HDGL50019 HDGL50020 HDGL50106 HDGL50733 HDGM50465 HDGM50663 HDGM50664 HDGM50702 HDGP51156 HDGQ51070 HDGQ51711 HDGS51245 HDGS51585 HDGS51588 HDGS51592 HDGS51593 HDGS51595 HDGS51600 HDGS51604 HDGS52370 HDGS52377 HDGS52380 HDGS52384 HDGS52385 HDGG54025 HDGH60268 HDGN50587 HDGN50598 HDGQ51194 HDGU60074 HDGU60075 HDGV60169 HDGE50372 HDGG54306 HDGG55066 HDGM51909 HDGL51449 HDGN50490 HDGQ50500 HDGQ51524 HDGQ51722 HDGQ51723 HDGQ51724 HDGQ51725 HDGQ51726 HDGQ51727 HDGQ51728 HDGQ51729 HDGQ51730 HDGQ51732 HDGT60589 HDGT… (truncated, 195891 characters total — see the official FDA record for the full value)
Recalling firm:
GE Medical Systems, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2026

Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940

Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

ALL 50 STATES
▸Full report

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

Recall #:
98922
Lot/product code:
UDI: 07290120281745; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
Recalling firm:
INSPIREMD Inc
View official FDA record (opens in a new tab)