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Recalls affecting Louisiana

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

16,895 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
UnclassifiedRisk not yet known
Medical deviceRecalled May 5, 2026

Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.

Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

ALL 50 STATES
▸Full report

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

Recall #:
98869
Lot/product code:
Model Number: 188. UDI-DI: 00821925001053. All Lot Numbers.
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 5, 2026

Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.

Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

ALL 50 STATES
▸Full report

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

Recall #:
98869
Lot/product code:
Model Number: 194. UDI-DI: 0082192500586. All Lot Numbers.
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 5, 2026

Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-501-30.

Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications

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 #:
D-0556-2026
Lot/product code:
Lot: 24123460, Expires: October 31, 2027.
Recalling firm:
Ascend Laboratories, LLC
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)
UnclassifiedRisk not yet known
Medical deviceRecalled May 5, 2026

Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.

Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

ALL 50 STATES
▸Full report

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

Recall #:
98869
Lot/product code:
Model Number: 188A. UDI-DI: 00821925001077. All Lot Numbers
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 5, 2026

Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.

Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

ALL 50 STATES
▸Full report

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

Recall #:
98869
Lot/product code:
Model Number: 190A. UDI-DI: 00821925003538. All Lot Numbers.
Recalling firm:
Olympus Corporation of the Americas
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

Good & Gather Mexican Street Corn Trail Mix 8 oz bag UPC 085239270240, 8 bags 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-0835-2026
Lot/product code:
BEST BY 23/MAR/2027 GY
Recalling firm:
JOHN B SANFILIPPO & SONS INC
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusRecalled May 5, 2026

Fisher Tex Mex Trail Mix 30 oz plastic jar UPC 070690275941, 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-0836-2026
Lot/product code:
BEST BY 08/06/27
Recalling firm:
JOHN B SANFILIPPO & SONS INC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 5, 2026

Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.

Software anomaly that causes a false display of error code 5018.

ALL 50 STATES
▸Full report

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

Recall #:
99064
Lot/product code:
Model No. MD2300F-001507; UDI-DI 00810071230226; Serial No. MDUF250342, MDUF250400, MDUF250429, MDUF250060, MDUF250061, MDUF250067, MDUF250068, MDUF250069, MDUF250071, MDUF250076, MDUF250083, MDUF250086, MDUF250091, MDUF250092, MDUF250104, MDUF250131, MDUF250133, MDUF250134, MDUF250159, MDUF250160, MDUF250199, MDUF250200, MDUF250202, MDUF250203, MDUF250204, MDUF250205, MDUF250240, MDUF250241, MDUF250242, MDUF250278, MDUF250297, MDUF250299, MDUF250312, MDUF250314, MDUF250325, MDUF250340, MDUF250341, MDUF250351, MDUF250352, MDUF250355, MDUF250367, MDUF250368, MDUF250370, MDUF250380, MDUF250384, MDUF250385, MDUF250395, MDUF250399, MDUF250409, MDUF250410, MDUF250427, MDUF250430, MDUF250431, MDUF250433, MDUF260009, MDUF260010, MDUF260011, MDUF260017, MDUF260019, MDUF260023, MDUF260024, MDUF260025, MDUF260026, MDUF260027, MDUF260032, MDUF260043, MDUF260067, MDUF260068, MDUF260070, MDUF260072, MDUF260077, MDUF260079, MDUF260094, MDUF260095, MDUF260096, MDUF260097, MDUF260098, MDUF260099, MDUF260100, MDUF260101, MDUF260103, MDUF260104, MDUF260105, MDUF260106, MDUF260107, MDUF260108, MDUF260109, MDUF260112, MDUF260115, MDUF250014, MDUF250015, MDUF250016, MDUF250050, MDUF250051, MDUF250052, MDUF250053, MDUF250054, MDUF250055, MDUF250056, MDUF250057, MDUF250058, MDUF250059, MDUF250062, MDUF250063, MDUF250064, MDUF250065, MDUF250066, MDUF250070, MDUF250072, MDUF250073, MDUF250074, MDUF250075, MDUF250084, MDUF250085, MDUF250088, MDUF250089, MDUF250090, MDUF250093, MDUF250102, MDUF250103, MDUF250105, MDUF250132, MDUF250145, MDUF250158, MDUF250161, MDUF250162, MDUF250198, MDUF250201, MDUF250206, MDUF250207, MDUF250220, MDUF250237, MDUF250238, MDUF250239, MDUF250243, MDUF250245, MDUF250279, MDUF250280, MDUF250295, MDUF250296, MDUF250298, MDUF250310, MDUF250311, MDUF250313, MDUF250323, MDUF250344, MDUF250348, MDUF250349, MDUF250350, MDUF250353, MDUF250357, MDUF250364, MDUF250365, MDUF250369, MDUF250371, MDUF250372, MDUF250378, MDUF250379, MDUF250381, MDUF250382, MDUF250383, MDUF250386, MDUF250393, MDUF250396, MDUF250397, MDUF250398, MDUF250407, MDUF250408, MDUF250411, MDUF250412, MDUF250428, MDUF250432, MDUF260016, MDUF260018, MDUF260020, MDUF260031, MDUF260041, MDUF260044, MDUF260069, MDUF260071, MDUF260078, MDUF260088, MDUF260089, MDUF260090, MDUF260091, MDUF260092, MDUF260093, MDUF250087, MDUF250208, MDUF250244, MDUF250324, MDUF250326, MDUF250354, MDUF250356, MDUF250394, MDUF260042, MDUF260045, MDUF260076; Software Version 2.2.
Recalling firm:
IPG Medical Corporation
View official FDA record (opens in a new tab)
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)
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 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: 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 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 Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Medline Kit Number/SKU DYNJ0040839

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 10889942046126 (each), 40889942046127 (case), Lot Numbers: 25JMK709, 25FMJ661, 25CMG042, 24IME549, 24GMD004, 24CMF091, 24CME465, 24BMH490.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Pre-connected Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND10407

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 10080196990740 (each), 40080196990741 (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

SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02

Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a multiple amplifier configuration (128 or 256 channels) running firmware version 2022.02 were displayed with a shift of 1 second between the 64channels blocks. In rare circumstances, a fixed 1-second temporal delay may appear between two 64-channel modules with firmware 2021.02, 2022.01 or 2022.02 in a multi-module SEEG configuration, potentially leading to misinterpretation of results.

ALL 50 STATES
▸Full report

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

Recall #:
98924
Lot/product code:
UDI-DI: 8033928120897; Lot Code: Model No SD LTM 64 PLUS; UDI-DI 8033928120897; Serial Numbers BAA-0051/01-19, BAA-0069/02-19, BAA-0070/02-19, BAA-0071/02-19, BAA-0082/02-19, BAA-0083/02-19, BAA-0084/02-19, BAA-0085/02-19, BAA-0086/02-19, BAA-0087/02-19, BAA-0088/02-19, BAA-0089/02-19, BAA-0090/02-19, BAA-0091/02-19, BAA-0092/02-19, BAA-0093/02-19, BAA-0095/02-19, BAA-0096/02-19, BAA-0098/02-19, BAA-0104/02-19, BAA-0105/02-19, BAA-0106/02-19, BAA-0107/02-19, BAA-0108/02-19, BAA-0109/02-19, BAA-0110/02-19, BAA-0111/02-19, BAA-0112/02-19, BAA-0113/02-19, BAA-0115/02-19, BAA-0116/02-19, BAA-0117/02-19, BAA-0118/02-19, BAA-0119/02-19, BAA-0121/02-19, BAA-0122/02-19, BAA-0142/03-19, BAA-0155/03-20, BAA-0156/03-20, BAA-0191/04-20, BAA-0192/04-20, BAA-0193/04-20, BAA-0194/04-20, BAA-0286/04-21, BAA-0287/04-21, BAA-0288/04-21, BAA-0289/04-21, BAA-0329/04-22
Recalling firm:
Micromed S.p.A.
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) BNT CV PACK, Medline Kit Number/SKU DYNJ912271; 2) CV PACK PART 1, Medline Kit Number/SKU DYNJ31204D; 3) KIT PERIPHERAL VASCULAR MMC, Medline Kit Number/SKU DYNJ905368D; 4) KIT PERIVASCULAR MMC, Medline Kit Number/SKU DYNJ905368B; 5) VP SHUNT PACK, Medline Kit Number/SKU DYNJ46530I.

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 DYNJ912271: UDI/DI 10198459688324 (each), 40198459688325 (case), Lot Number 26CBQ109; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 25FBO720; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24KBO387; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24KBO015; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24KBD819; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24KBA736; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24FBG144; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24DBO838; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24BBC453; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24ABM118; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 23KBS950; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 23IBC670; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 22LBN883; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 22KBF121; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 22IBN293; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 22FBO695; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 22OBH349; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 21JBY498; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 21JBY507; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 21JBH105; Medline Kit Number/SKU DYNJ905368D: UDI/DI 10198459698149 (each), 40198459698140 (case), Lot Number 26DBE022; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 25GBD045; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 25EBN367; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 25CBR397; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 25BBK435; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 25ABR151; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 24JBU152; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 24IBD106; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 24HBI890; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 24GBS879; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 24EBB182; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 24CBT638; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 24CBN624; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23KBU577; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23IBS119; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23GBV028; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23HBO351; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23BBL739; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23BBL740; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23ABS355; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23ABG430; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 22GBG375; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 22GBG376; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 22GBG377; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lo… (truncated, 5797 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: 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) 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: 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) 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: 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 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)