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

9451–9475 of 27393

SevereFDA (Devices)·Z-1560-2022·2022-08-31
Getinge Servo ventilator systems recalled for loss of ventilation
Getinge Servo ventilators may fail to deliver ventilation and stop functioning, potentially causing oxygen deprivation and serious harm to critical care patients.
Product
Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ventilator: Part Number 6888800 Servo-air: Part Number 6882000
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1525-2022·2022-08-31
Intensive care ventilator status board may loosen, causing water damage and malfunction
Hamilton's HAMILTON-C6 intensive care ventilator status indicator board may become loose, allowing water or disinfectants to enter the device and cause technical faults that could force the ventilator into unsafe modes where patients breathe unassisted room air.
Product
HAMILTON-C6 Intensive Care Ventilator, REF: 160021
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1561-2022·2022-08-31
Diaphragm pacing system external pulse generator recalled for circuit board defect
Synapse Biomedical is recalling the NeuRx Diaphragm Pacing System External Pulse Generator due to a circuit board defect causing performance degradation, potentially leading to cardiac complications, breathing failure, or device shutdown.
Product
NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-1581-2022·2022-08-31
Baxter DISCPAC Syringe Tip Caps Recalled for Potential Sterile Barrier Failure
Baxter is recalling DISCPAC Syringe Tip Caps due to potential packaging defect that may not maintain sterile barrier. The recall affects 8,500 units distributed worldwide.
Product
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Purple, 100 pack, REF H938677100
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-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
HighFDA (Devices)·Z-1590-2022·2022-08-31
Alcon Contact Lens Solutions Recalled for Temperature Exposure During Storage and Transit
Multiple Alcon contact lens solutions were recalled due to facility temperature excursions during storage and transit that may have reduced product effectiveness. Affected products include Clear Care and Opti Free Replenish solutions distributed nationwide between June and September 2021.
Product
a. Alcon Clear Care Contact Lens Solution Clear Care 12 oz. Solution, Model Number: 65035820, Model Number: USSCupA-12BUP300. b. Alcon Contact Lens Solution Opti Free Replenish 4 oz. Solution Model Number: 00065035604 Model Number: USSCupA-12BUP300. c. Alcon Contact L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1623-2022·2022-08-31
Medical device recall for temperature exposure during storage
McKesson Medical-Surgical is recalling multiple medical devices that experienced temperature excursions during storage and transport. Exposure to higher temperatures from June through August 2021 may have reduced product effectiveness.
Product
a. DERMA SCIENCES, INC. NG Strip FASTENER, NASAL TUBE IND WRAP(25/BX), Catalog NG25. b. DERMA SCIENCES, INC. Surgitube BANDAGE, GAUZE #2P 7/8"X50YDS DERSCI Catalog GL-242. c. DERMA SCIENCES, INC. Surgilast TUBE NET SZ3 MED 10YDS/EA HAND, ARM, LEG, FOOT SURGILAST Catalog
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1586-2022·2022-08-31
ABX PENTRA Creatinine Reagent Recalled Due to Temperature Excursion Exposure
Mckesson Medical-Surgical is recalling ABX PENTRA Creatinine reagent due to facility temperature excursions (June-August 2021) that may have impacted product effectiveness. Affected lots were received nationwide between June 1 and September 30, 2021.
Product
a. ABX PENTRA CREATININE 120CP JAFFE 120/130. Ref: A11A01933. b. Reagent General Chemistry Creatinine Model Number: 1220001933
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-1577-2022·2022-08-31
Baxter DISCPAC Syringe Tip Caps recalled for packaging sterility concerns
Baxter Healthcare is recalling DISCPAC Syringe Tip Caps due to potential packaging failures that could compromise the sterile barrier on 10,140 units distributed worldwide.
Product
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, White REF H938671100
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-1591-2022·2022-08-31
Perifix LOR Syringes Recalled Due to Temperature Exposure During Storage
Mckesson recalled 415 Perifix LOR syringes (Model 332152) distributed nationwide due to temperature excursions from June to August 2021 that may have affected product effectiveness. No illnesses have been reported.
Product
Perifix LOR Syringe Perifix 8 mL Pouch Luer Lock Tip Without Safety Model Number: 332152
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1568-2022·2022-08-31
Servo-air Ventilator Systems Lack Required Stability Warning Markings
Getinge is recalling Servo-air Ventilator Systems because they lack required warning markings about stability risks when stationary. A total of 102 units were distributed in the US; 13,750 units were distributed internationally.
Product
Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric and adult patients. Model Number: 6882000 (equipped with 6881999 mobile cart)
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-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-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-1601-2022·2022-08-31
McKesson Colorectal Cancer Screening Tests Recalled Due to Temperature Exposure
McKesson Medical-Surgical is recalling MMS - IMMUNOSTICS INC colorectal cancer screening test kits due to facility temperature excursions that may have reduced product effectiveness. The recall affects lots distributed between June and September 2021.
Product
a. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit Consult Colorectal Cancer Screening Fecal Occult Blood Test (iFOB or FIT) Stool Sample 25 Tests, Model Number: 4487. b. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit McKesson Consult Colorectal Cancer Screening Fecal Occult Blo
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-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-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-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-1615-2022·2022-08-31
MedSource IV Start Kit Recalled for Temperature-Related Effectiveness Loss
McKesson is recalling MedSource IV Start kits due to facility temperature excursions that may have compromised product effectiveness. Affected units were received between June and September 2021.
Product
MedSource IV Start kit, 8inch Extension Set IV START KIT, W/SITE LOC/8" EX100/CS Model Number: MS-80047
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1584-2022·2022-08-31
Surgical Hemostatic Matrix Recalled Due to Temperature Exposure During Storage
Mckesson is recalling Ethicon SURGIFLO Hemostatic Matrix Kit due to temperature excursions during storage that may have reduced product effectiveness. Affected units were distributed nationwide between June and September 2021.
Product
Ethicon SURGIFLO Hemostatic Matrix Kit with Thrombin (6/CS) Ref: 2994 Mfg: FERROSAN MEDICAL DEVICES A/S Indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1621-2022·2022-08-31
Medical Sponges Recalled for Temperature Exposure During Storage
Mckesson Medical-Surgical is recalling MetriSponge cleaning sponges due to facility temperature excursions that may have compromised product effectiveness during storage and delivery between June and August 2021.
Product
METREX RESEARCH CORP SPONGE, METRISPONGE W/METRIZYME (25/BX 4BX/CS) Model Number: 10-4025
Category
Medical Device
Distribution
Distributed nationwide

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9451–9475 of 27393