Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

7901–7925 of 40056

SevereFDA (Devices)·Z-1107-2024·2024-03-06
Dialysis Irrigation Solutions Recalled for Potential Sterility Defect
Medline Industries is recalling 10,391 units of dialysis kits and accessory packs due to potential sterility defects in component solutions. Non-sterile irrigation fluids could cause serious infection if used.
Product
Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIALYSIS ON KIT, REF DT21235A; c) INFUSA PORT KIT, REF DYNDC3166A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1163-2024·2024-03-06
Medtronic Duet External Drainage System Recalled for Catheter Disconnection Risk
Medtronic is recalling its Duet External Drainage and Monitoring System due to potential catheter disconnection from patient line stopcock connectors. This device is used to drain cerebrospinal fluid and reduce intracranial pressure.
Product
Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1094-2024·2024-03-06
Medline Arterial Irrigation Bundles Recalled Due to Sterility Risk
Medline Industries recalls arterial irrigation bundles due to potential loss of sterility in Nurse Assist components, which could deliver non-sterile solutions for medical procedures.
Product
MEDLINE ARTERIAL BUNDLE NO CATHETER, REF ART995
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1133-2024·2024-03-06
Medline Tracheostomy Care Trays Recalled for Sterility Issues
Medline Industries is recalling 528 latex-free tracheostomy care trays due to potential sterility failure in component irrigation solutions. Non-sterile solutions pose infection risk.
Product
Centurion Kits, trays, and packs labeled as follows: LATEX FREE TRACHEOSTOMY CARE TRAY, REF TC7170
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1063-2024·2024-03-06
AirLife Adult Manual Resuscitator recalled for ventilation failure risk
Vyaire Medical is recalling 4,572 units of AirLife Adult Manual Resuscitators due to defective components that may cause improper ventilation or complete ventilation failure, potentially resulting in hypoventilation, hypoxia, or death.
Product
AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1111-2024·2024-03-06
Medline Medical Device Kits Recalled for Potential Sterility Loss
Medline Industries is recalling 26,171 kits and trays containing potentially non-sterile irrigation solutions and syringes supplied by Nurse Assist, which could pose risks if used in medical procedures.
Product
Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G; b) ABDOMEN PACK, REF DYNJ53643C; c) BAG TRUNK STOCK KIT, REF DYKM1880; d) BEDSIDE BRONCH PACK, REF DYKE1601; e) BIOPSY TRAY, REF DYNDH1242; f) BRONCH KIT, REF DYKE18
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1090-2024·2024-03-06
Medline Tracheal Care Trays Recalled Due to Sterility Concerns
Medline Industries is recalling 385,028 tracheostomy care trays due to potential sterility issues with certain components. The kits were distributed nationwide and internationally.
Product
MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1059-2024·2024-03-06
AirLife Adult Manual Resuscitator recalled for faulty component causing ventilation failure
Vyaire Medical is recalling 8,220 AirLife Adult Manual Resuscitators with defective duckbill and ring components. The manufacturing defect may prevent proper ventilation and could lead to hypoxia or death.
Product
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1165-2024·2024-03-06
Medtronic Duet Ventricular Catheter Recalled for Disconnection Risk
Medtronic is recalling 11,840 units of its Duet External Drainage and Monitoring System due to potential disconnection between the catheter and stopcock connectors. This defect could impair the device's ability to drain cerebrospinal fluid.
Product
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1164-2024·2024-03-06
Medtronic Duet External Drainage System catheter disconnection risk recalled
Medtronic recalls Duet External Drainage and Monitoring System catheter units (REF 46915) due to potential disconnection from stopcock connectors. Worldwide distribution includes 14,139 units.
Product
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1130-2024·2024-03-06
Medline Centurion dialysis kits recalled due to sterility concerns
Medline Industries is recalling approximately 10,391 Centurion dialysis kits due to potential lack of sterility in Nurse Assist components. Products were distributed nationwide and in select international locations.
Product
Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIALYSIS ON KIT, REF DT21235A; c) INFUSA PORT KIT, REF DYNDC3166A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1092-2024·2024-03-06
MEDLINE Irrigation and Tracheostomy Kits Recalled for Potential Sterility Failure
MEDLINE Industries is recalling 385,028 units of suction catheter and tracheostomy care kits due to potential lack of sterility in Nurse Assist irrigation components. Affected kits were distributed in the US, Puerto Rico, Canada, UAE, and Panama.
Product
MEDLINE kits and trays, labeled as: a) SUCTION CATH 10FR KIT W/SALINE, REF DYND41470SA, DYND41470SAH; b) TRACH CARE TRAY, REF DYNDA1931B, DYNDA1931BH
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1108-2024·2024-03-06
Medline Instrument Trays Recalled for Potential Sterility Defect
Medline Industries is recalling 228 medical device trays due to potential sterility defects in component solutions used in medical procedures.
Product
Medline Kits, trays, and packs labeled as follows: TRAY,L&D INSTRUMENT, REF DYNDL1550
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1131-2024·2024-03-06
Medline Centurion Eye Prep Kit Sterilization Defect Recall
Medline Industries is recalling Centurion Eye Prep Kits due to potential lack of sterility in irrigation solution components manufactured by Nurse Assist.
Product
Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1096-2024·2024-03-06
Medline Medical Kits Recalled for Potential Sterility Defect
Medline Industries is recalling multiple surgical and critical care kits due to a potential lack of sterility in component solutions (sodium chloride irrigation, sterile water for irrigation, and saline flush syringes). Non-sterile solutions could expose patients to infection.
Product
MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF DYNDC3106, b) ENDO KIT, REF DYKE1346D, c) ENDO KIT, REF DYKE1892A, d) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648G, e) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I, f) FREQUENT DAILY VAD, REF DYN
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1100-2024·2024-03-06
MEDLINE Serum Tear Kit Irrigation Solutions Recalled for Sterility Concerns
Medline is recalling serum tear kit irrigation solutions due to potential sterility defects. The solutions may not be sterile, posing contamination risks during medical use.
Product
MEDLINE Kits, trays, and packs labeled as follows: SERUM TEAR KIT, REF DYNDA1545
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1128-2024·2024-03-06
Medline Suction Catheter Kits Recalled for Potential Sterility Defects
Medline Industries is recalling 1,012,700 suction catheter kits manufactured with irrigation solutions that may lack sterility. The recalled products are distributed nationwide and internationally.
Product
Medline Kits, trays, and packs labeled as follows: a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470; b) KIT,SUCTION CATH,12FR W/H20 12, REF DYND41471; c) KIT,SUCTION CATH,14FR W/SALIN, REF DYND40442; d) KIT,SUCTION CATH,14FR W/WATER, REF DYND41472; e) KIT,SUCTION CATH,1
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1065-2024·2024-03-06
AirLife Manual Resuscitator recalled for broken components causing ventilation failure
Vyaire Medical is recalling approximately 1.8 million AirLife Adult Manual Resuscitators worldwide due to faulty molded components that may fail to deliver proper ventilation, risking hypoventilation and hypoxia.
Product
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1118-2024·2024-03-06
Medline Laceration Trays Recalled Due to Sterility Defect
Medline is recalling laceration trays and medical kits with approximately 12,000 units due to sterility defects in component solutions. Non-sterile medical devices could pose infection risk during wound care procedures.
Product
Medline Kits, trays, and packs labeled as follows: a) ER LACERATION TRAY - SNAG FREE, REF SUT12825; b) LACERATION TRAY, REF SUT21580; c) LACERATION TRAY, REF DYNDL1484B;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1124-2024·2024-03-06
Medline Surgical Kits Recalled Due to Sterility Defect in Irrigation Solutions
Medline Industries recalls certain surgical kits and trays because irrigation solution components may lack sterility, creating potential infection risk.
Product
Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1137-2024·2024-03-06
Centurion breast biopsy kits recalled due to potential sterility issues
Medline Industries is recalling Centurion breast biopsy kits due to a potential lack of sterility in component solutions.
Product
Centurion Kits, trays, and packs labeled as follows: BREAST BIOPSY KIT, REF MNS4360
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1119-2024·2024-03-06
Medline Tracheostomy Care Kits and Trays Recalled Due to Sterility Concerns
Medline Industries is recalling tracheostomy care kits and trays due to potential lack of sterility in their component irrigation solutions. The non-sterile solutions pose a risk during patient care procedures.
Product
Medline Kits, trays, and packs labeled as follows: a) TRACH CARE KIT, REF DYND40589; b) TRACH CARE KIT, REF DYNDA3004; c) TRACHEOSTOMY CARE TRAY, REF DYND40650; d) TRAY,TRACH,W/PCLNR,14FR CATH N, REF DYND40594
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1106-2024·2024-03-06
MEDLINE Surgical Kits Recalled Due to Potential Sterility Failure
MEDLINE is recalling surgical kits, trays, and packs due to potential lack of sterility in component solutions. The recalled products were distributed nationwide and internationally.
Product
MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b) PANENDOSCOPY-LF, REF DYNJ36728C; c) UMBILICAL VESSEL INSERTION, REF UVT1170; d) UMBILICAL VESSEL INSERTION, REF UVT1170H
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1116-2024·2024-03-06
Medline Prep Kits Recalled Due to Non-Sterile Components
Medline is recalling 1,270 prep kits containing components that may lack sterility. Solutions from Nurse Assist used in the kits may not be sterile.
Product
Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664; b) DMEK PREP PACK, REF DYNJ81659A; c) PRE OP KIT 1, REF DYKS1377; d) PRE OP KIT 1, REF DYKS1377A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1166-2024·2024-03-06
Medtronic Duet Catheter System Recalled for Potential Disconnection Risk
Medtronic Duet External Drainage System catheters may disconnect from stopcocks, potentially compromising cerebrospinal fluid management. The FDA Class I recall affects 3,889 units distributed worldwide.
Product
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
Category
Medical Device
Distribution
Distributed nationwide

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7901–7925 of 40056