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

11301–11325 of 13816

HighFDA (Devices)·Z-1620-2022·2022-08-31
Medical disinfectant recalled due to temperature exposure during storage
McKesson is recalling CaviCide and EnviroCide disinfectants that may have been exposed to excessive temperatures during storage from June to August 2021, potentially reducing their effectiveness.
Product
a. METREX RESEARCH CORP CaviCide1 DISINFECTANT, CLNR CAVICIDE1 1GL (4/CS) METREX, Model Number: 13-5000. b. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE 8OZ SPRAY MX-1008 METREX Model Number: 13-1008. c. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE GL MX
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1593-2022·2022-08-31
Mckesson Ultracell Eye Pledgets Recalled Over Temperature Exposure During Storage
Mckesson Medical-Surgical is recalling Ultracell Eye Pledgets (Model 40825) due to temperature excursions during storage and transportation between June and August 2021 that may have compromised product effectiveness. Affected units were distributed nationwide from June through September 2021.
Product
Ultracell Eye Pledget Ultracell 2 X 6 X 1 mm, Sterile Model Number: 40825
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1597-2022·2022-08-31
LeadCare II Blood Lead Test Kit Recalled Due to Temperature Storage Issues
81 kits of LeadCare II blood lead test devices were recalled because temperature exposure during storage may have impacted product effectiveness. The affected lots were received between June and September 2021.
Product
MAGELLAN DIAGNOSTICS LeadCare II Blood Lead Test Kit Rapid Test Kit LeadCare II General Chemistry Blood Lead Test Whole Blood Sample 48 Tests Model Number: 70-6762
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1632-2022·2022-08-31
Morrison Medical OB Kit Recalled Due to Temperature Excursion During Storage
Mckesson is recalling Morrison Medical OB Kits because facility temperature excursions may have reduced product effectiveness. All lots received between June 1 and September 30, 2021 are affected.
Product
MORRISON MEDICAL Morrison Medical OB KIT, HARD PK SEALED W/CARDBOARD BX MORMED Catalog #0967NL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1570-2022·2022-08-31
FDA Recalls Exacta-Mix 2400 Compounding System for Potential Valve Leaks
Baxter Healthcare is recalling the Exacta-Mix 2400 compounding system due to potential leaking valves on ports 1-4 in certain lots. Affected units have lot numbers 60316024 and higher.
Product
The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. This device is not intended for direct patient hook-up.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1585-2022·2022-08-31
Medical Device Etching Solution Recalled for Potential Temperature-Related Effectiveness Loss
ABX Pentra Etching CP solution is recalled due to temperature excursions from June-August 2021 that may have affected product effectiveness. Affected lots were distributed June 1 - September 30, 2021.
Product
HORIBA ABX MEDICAL INC ABX PENTRA ETCHING CP System Fluid ABX Pentra Eching Solution CP For ABX Pentra 400 Clinical Chemistry Analyzer 25 mL. Ref: 1220001769
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1617-2022·2022-08-31
BD Vacutainer Urine Collection Tubes Recalled for Temperature Exposure
Mckesson Medical-Surgical is recalling BD Vacutainer urine collection tubes and kits due to facility temperature excursions from June to August 2021 that may have compromised preservative effectiveness. All lots distributed between June 1 and September 30, 2021 are affected.
Product
a. BECTON DICKINSON BD Vacutainer C&S Preservative Urine Tube TUBE, URINE COLL PLAS 4ML (100/BX 10BX/CS), Model Number: BD 364951. b. BECTON DICKINSON BD Vacutainer C&S Transfer Straw Kit TRANSFER STRAW KIT, URINE 4ML(50/BX 4BX/CS) Model Number: BD 364953. c. BECTON DICK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1626-2022·2022-08-31
LASIK Irrigation Cannula Recalled for Potential Temperature Exposure Damage
Beaver-Visitec medical irrigation cannulas used in LASIK eye surgery are being recalled due to storage temperature excursions. Units distributed from June through September 2021 may have reduced effectiveness.
Product
BEAVER-VISITEC INTERNATIONAL, INC. Visitec CANNULA, LASIK IRR (10/BX)BVRVIS Catalog #585278
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1575-2022·2022-08-31
Baxter DISCPAC Syringe Tip Caps Recalled for Compromised Sterile Barrier
Baxter Healthcare is recalling DISCPAC Syringe Tip Caps due to potential packaging failure that could compromise the sterile barrier. The recall affects 602,340 units distributed worldwide.
Product
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow: a) 25 pack, REF H93866025, b) 100 pack, REF H93866100, c) 25 pack, REF H938690025
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1613-2022·2022-08-31
McKesson GYNECATH H/S Catheter Recalled Due to Temperature Excursions Prior to Delivery
McKesson recalls gynecological catheters that may have been exposed to temperatures higher than intended during storage, potentially affecting product effectiveness. Affected units were received between June and September 2021.
Product
Mckesson GYNECATH H/S CATHETER 5FR (10/CS) Model Number: 11-19610
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1579-2022·2022-08-31
Baxter Syringe Tip Caps Recalled for Potential Sterile Barrier Failure
Baxter Healthcare Corporation is recalling 168,390 units of DISCPAC Syringe Tip Caps because the packaging may not maintain a sterile barrier, creating a contamination risk.
Product
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Green: a) 25 pack, REF H93869025, b) 100 pack, REF H938674100, c) 100 pack, REF H93869100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1629-2022·2022-08-31
Beckman Coulter Laboratory Reagents Recalled for Temperature-Related Effectiveness Loss
Beckman Coulter diagnostic reagents used in blood analysis systems were recalled after exposure to temperature excursions during storage and shipment. Products received between June and September 2021 may have reduced effectiveness.
Product
BECKMAN COULTER, INC. a. COULTER DxH Diff Pack REAGENT, DIFF PK FP DXHCOULTR, Catalog #628020. b. COULTER DxH Cleaner REAGENT, CLEANER FP DXH 10LCOULTR Catalog #628023. c. DxH 500 Series Lyse LYSE, VERSA SOL DXH 500 SERIES(0.5L/KT) Catalog # B36846. d. DxH 500 Serie
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1564-2022·2022-08-31
NUCLISENS easyMAG Magnetic Silica Reagent Kit Contamination Recall
bioMerieux recalls NUCLISENS easyMAG Magnetic Silica reagent kits due to contamination that may cause test failures or delayed results. Affected kits were distributed across 23 U.S. states.
Product
NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
Category
Medical Device
Distribution
24 states
HighFDA (Devices)·Z-1578-2022·2022-08-31
Baxter DISCPAC Syringe Tip Caps recalled due to sterile barrier failure
Baxter Healthcare is recalling DISCPAC Syringe Tip Caps because packaging may not maintain a sterile barrier. Affected units were distributed worldwide including the US, Australia, Finland, Germany, Spain, and the UK.
Product
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack REF H938693025, b) 100 pack REF H938673100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1602-2022·2022-08-31
Ultrasound Probe Disinfectant Recalled: Temperature Exposure May Affect Effectiveness
Nanosonics Sonex-HL ultrasound probe disinfectant is recalled due to temperature excursions during storage that may have affected product effectiveness.
Product
NANOSONICS LTD Sonex-HL Ultrasound Probe Disinfectant trophon Sonex-HL 80 mL Bottle For Trophon EPR Disinfection System Model Number: N00037
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1625-2022·2022-08-31
Surgical ophthalmic wicks recalled for potential effectiveness loss
McKesson Medical-Surgical Inc. is recalling Beaver-Visitec Ultracell surgical wicks due to facility temperature excursions during storage. Temperature exposure may have impacted product effectiveness, affecting units distributed nationwide between June and September 2021.
Product
BEAVER-VISITEC INTERNATIONAL, INC. Ultracell WICK, FENSTD PED 7MMX20MM(10/BX) BVRVIS Catalog #30316-C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1607-2022·2022-08-31
Chest Drain System Atrium 2100 mL recalled due to temperature exposure
The GETINGE OCEAN Chest Drain System Atrium 2100 mL is being recalled due to facility temperature excursions from June-August 2021 that may have impacted product effectiveness. Affected units were distributed nationwide between June 1 and September 30, 2021.
Product
GETINGE USA SALES LLC OCEAN Chest Drain System Atrium 2100 mL Model Number: 2002-000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1571-2022·2022-08-31
Vanta Clinician Programmer Application error prevents programming of implanted neurostimulators
The Vanta Clinician Programmer Application v2.0.2455 may display Error Code 1502, preventing users from programming Vanta implantable neurostimulators. The issue affects 2,920 downloaded software applications distributed worldwide.
Product
Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1608-2022·2022-08-31
3M Grounding Safety Ring Pads Recalled Due to Temperature Exposure
3M Grounding Safety Ring pads may have been exposed to excessive temperatures during storage, potentially compromising product effectiveness. The recall affects products distributed nationwide that were received between June and September 2021.
Product
3M COMPANY 3M PAD, GROUNDING SAFETY RING Model Number: 9165
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1559-2022·2022-08-31
EVIS EXERA III Bronchovideoscope Recalled Due to Veterinary Use Before Clinical Assignment
An EVIS EXERA III Bronchovideoscope was recalled after being used in a veterinary endoscopy procedure before assignment to healthcare facilities. The device presents a potential contamination risk.
Product
EVIS EXERA III Bronchovideoscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1630-2022·2022-08-31
Centurion Catheter Kits Recalled Due to Temperature Exposure
Mckesson Medical-Surgical is recalling Centurion catheter kits that were exposed to higher temperatures during facility storage prior to delivery, which may have impacted product effectiveness. All units distributed nationwide between June 1 and September 30, 2021 are affected.
Product
CENTURION MEDICAL PRODUCTS, LP Centurion CATH KIT, FML W/LUBE 8FR (50/CS) CNTURN Catalog # CKF105L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1588-2022·2022-08-31
Drug screening tablets affected by temperature exposure during storage
McKesson is recalling Alere Toxicology drug screening tablets due to temperature excursions during facility storage that may have reduced product effectiveness. Affected units were received between June and September 2021.
Product
Alere Toxicology TABLET, INSTANT BLUING F/DRUGSCREEN Model Number: 7875
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1565-2022·2022-08-31
Dental Implant Recall: Nobel Biocare Device Burr Aspiration Risk
Nobel Biocare is recalling 347 N1 TiUltra TCC dental implants due to a burr that may pose an aspiration risk during surgical implantation. No injuries have been reported.
Product
Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1562-2022·2022-08-31
DeRoyal Limb Holders and Security Cuffs Buckle Webbing Strap Failure
DeRoyal is recalling specific limb holders and security cuffs due to improperly laced webbing straps that may slide loose, potentially compromising device security.
Product
DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankle, Fixed, Quick Release, REF M8125; (3) DeRoyal Security Cuffs, Wrist and Ankle, Universal, REF M8136; and (4) DeRoyal Security Cuffs, Heavy Duty Vertical Psy
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1583-2022·2022-08-31
McKesson blood coagulation test kits recalled for temperature storage damage
McKesson recalls Coag-Sense blood coagulation test kits nationwide due to facility temperature excursions that may have affected test effectiveness.
Product
a. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin Time Test (PT/INR) Whole Blood Sample 50 Tests-IVD. Part No. 0356-50. b. Coagulation Control Kit Coag-Sense PT / INR Test (Prothrombin Time Test) Low Level / High Level 10 Strips Part No. 03P69-10
Category
Medical Device
Distribution
Distributed nationwide

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11301–11325 of 13816