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FDA food · drug · device recalls, merged

Before you eat it, take it, or plug it in — check.

Big Nope pulls three separate FDA recall feeds into one list per state, so you’re not searching three government databases to get one answer.

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)

Recalls nationwide

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

19,424 recalls found
NewestOldest
High riskLow riskAll
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled May 6, 2026

Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004

Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.

CACOFLGAIDILMDMIMNMOMSNENJNVOKORSCTXVAWAWI
▸Full report

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

Recall #:
98945
Lot/product code:
Model Number: LVP-0004; UDI-DI: 00811505030320; All Serial/Lot Numbers:
Recalling firm:
Fresenius Kabi USA, LLC
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusRecalled May 5, 2026

72% CACAO CHOCOLATE WITH DATE SUGAR WAFERS Ingredients: Cacao Beans, Organic Date Powder, Organic Cocoa Powder Net Wt 25lb (11.3kg) Made in the USA GUITTARD CHOCOLATE COMPANY Burlingame, CA 94010 Item: 0568C25 UPC: 00071818367654

Potential contamination with Salmonella

OH
▸Full report

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

Recall #:
H-0861-2026
Lot/product code:
Lot code, Best By: 11775A, 12/27/2026; 21775A, 12/27/2026; 31785A, 12/28/2026; 11785A, 12/28/2026; 21785A, 12/28/2026; 22095M, 01/28/2027; 12105M, 01/29/2027; 22105M, 01/29/2027.
Recalling firm:
Guittard Chocolate Company
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)
Class IHigh risk
FoodBacteria/virusRecalled May 5, 2026

giant eagle Baked Pita Chips with Parmesan, Garlic & Herb Bagel Crisps, Net Wt 7.33 oz. Shipping Case: 12 ct - 7.33 oz Bags Net Weight: 5.49 lbs. Legacy Bakehouse, LLC, Waukesha WI 53186.

Products were made with recalled California Dairies milk powder due to Salmonella.

PAWI
▸Full report

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

Recall #:
H-0852-2026
Lot/product code:
Shipping Case Lot # 071626
Recalling firm:
Legacy Bakehouse LLC
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

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

Southern Style Nuts Hunter Mix 30 oz plastic jar UPC 085839916302, 4 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-0832-2026
Lot/product code:
BEST BY 01/29/27 BEST BY 02/03/27 BEST BY 02/10/27 BEST BY 02/19/27 BEST BY 02/24/27 BEST BY 03/02/27 BEST BY 03/10/27 BEST BY 03/16/27
Recalling firm:
JOHN B SANFILIPPO & SONS INC
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusRecalled May 5, 2026

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

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

Parmesan & Herb Bagel Crisps, Item Number 18139, Net Weight: 10 lbs. Legacy Bakehouse, LLC, N8W22100 Johnson Dr., Waukesha, WI 53166.

Products were made with recalled California Dairies milk powder due to Salmonella.

PAWI
▸Full report

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

Recall #:
H-0851-2026
Lot/product code:
Lot # / Production Date: 29 JAN 2026 and 12 APR 2026
Recalling firm:
Legacy Bakehouse LLC
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)
Class IHigh risk
FoodBacteria/virusRecalled May 5, 2026

Stoltzfus Family Farm Sour Cream and Onion cheese curds, 8-ounce

Product may be contaminated with Salmonella.

NYPA
▸Full report

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

Recall #:
H-0848-2026
Lot/product code:
Best by: 03/25/2026, 04/23/2026, 04/29/2026, 05/06/2026 UPC Codes: 8 59166 00201 0
Recalling firm:
Stoltzfus Family Dairy LLC
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)
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)
Class IHigh risk
FoodBacteria/virusRecalled May 5, 2026

Butter Parsley Bagel Crisps, Item Number 18490, Net Weight: 10 lbs. Legacy Bakehouse, LLC, N8W22100 Johnson Dr., Waukesha, WI 53166.

Products were made with recalled California Dairies milk powder due to Salmonella.

PAWI
▸Full report

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

Recall #:
H-0850-2026
Lot/product code:
Lot # / Production Date: 29 JAN 2026 and 12 APR 2026
Recalling firm:
Legacy Bakehouse LLC
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 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 4, 2026

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

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

ALL 50 STATES
▸Full report

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

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

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

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

ALL 50 STATES
▸Full report

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

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

MEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Kit Number/SKUDYNJ86253A

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 10198459556654 (each), 40198459556655 (case). Lot Numbers: 25KBC063, 25JBO955.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

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

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

ALL 50 STATES
▸Full report

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

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

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

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

ALL 50 STATES
▸Full report

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

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

MEDLINE 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.

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▸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: 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)