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

1851–1875 of 5038

SevereFDA (Devices)·Z-0907-2022·2022-04-27
Philips Respironics V60 Ventilator Recalled Due to Electrical Circuit Defect
Philips Respironics V60 ventilators are recalled due to an internal electrical circuit defect that may cause the device to stop operating. Approximately 87,138 units worldwide are affected.
Product
Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R1053618, R1076709)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0908-2022·2022-04-27
Philips Respironics V60 Plus Ventilator Recalled for Electrical Circuit Failure Risk
Philips Respironics V60 Plus Ventilators are recalled for an internal electrical circuit defect that could cause the device to stop operating. Approximately 12,145 units were affected worldwide.
Product
Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0927-2022·2022-04-27
Medtronic Harmony Delivery Catheter System Recalled Over Equipment Failure Risk
Medtronic is recalling 1,483 Harmony Delivery Catheter Systems due to potential capsule bond failure during pulmonary valve replacement procedures. The FDA has classified this as a Class I recall affecting devices distributed in the US and Canada.
Product
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0909-2022·2022-04-27
Philips Respironics V680 Ventilator May Stop Operating Due to Electrical Fault
Philips Respironics V680 Ventilators may stop operating due to an internal electrical circuit fault. Units were distributed worldwide and across the United States.
Product
Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United States
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0918-2022·2022-04-20
Cub 2 Enclosed Bed Canopy System Recalled Due to Potential Misuse
Sensory Medical Inc recalled 225 units of the Cub 2 Enclosed Bed Canopy System for potential misuse risk. The firm is updating product warnings and precautions for devices distributed before December 16, 2021.
Product
Cub 2 Enclosed Bed Canopy System
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0785-2022·2022-03-30
Philips Respironics respiratory ventilators recalled for foam degradation
Philips Respironics recalls 229,353 respiratory ventilators because polyester-polyurethane foam may degrade and release particles. Foam degradation could compromise ventilator function.
Product
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not i
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0719-2022·2022-03-23
Unauthorized COVID-19 Diagnostic Test Kits Imported Without FDA Approval
SD Biosensor's STANDARD Q COVID-19 Ag Home Test kits were illegally imported without FDA approval, clearance, or authorization. Approximately 400,000 units were distributed nationwide.
Product
STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0718-2022·2022-03-16
FDA Recalls COVID-19 Antibody Test Kits for Lacking Regulatory Authorization
Lusys Laboratories is recalling 33,955 COVID-19 antibody test kits distributed across the US and internationally because the product lacks FDA authorization, clearance, or approval for marketing or use.
Product
COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0716-2022·2022-03-16
LuSys COVID-19 Antigen Test Kits Recalled for Lack of FDA Authorization
Lusys Laboratories is recalling 14,745 kits of COVID-19 antigen test kits that lack FDA clearance, approval, or emergency use authorization. The kits were distributed nationwide and internationally without required regulatory validation.
Product
LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0717-2022·2022-03-16
Luscient Diagnostics COVID-19 Antigen Test Kits Recalled for Lack of FDA Authorization
Lusys Laboratories' Luscient Diagnostics COVID-19 Antigen Test Kits are being recalled because they lack FDA authorization. The kits were not approved, cleared, or authorized for distribution in the United States.
Product
Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0694-2022·2022-03-16
Medtronic TurboHawk Plus Directional Atherectomy System Recalled Due to Design Defect
ev3 Inc. is recalling the Medtronic TurboHawk Plus Directional Atherectomy System due to design similarities to a device with reported tip detachment and embolization incidents. The FDA has classified this as a Class I recall.
Product
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0695-2022·2022-03-16
Medtronic TurboHawk Plus atherectomy system recalled for potential tip detachment
The Medtronic TurboHawk Plus Directional Atherectomy System (catalog THP-S) is being recalled due to design similarities to another device that experienced tip detachment and embolization. The recall affects 245 devices distributed nationwide.
Product
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0662-2022·2022-03-09
Philips V60 Ventilator Recall: Expired Adhesive May Cause Device Failure
A limited number of Philips Respironics V60 ventilators were assembled with expired adhesive. If the adhesive fails, the ventilator could stop providing ventilation.
Product
Philips Respironics V60 Ventilator Part Number 1053617
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-0659-2022·2022-03-09
COVID-19 Rapid Test Kits Recalled for Risk of False Positive Results
Celltrion DiaTrust COVID-19 Ag Rapid Test kits from lot COVGCCM0008 are being recalled due to reports of false positive results. The affected 243 kits were distributed to six states before the recall.
Product
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Category
Medical Device
Distribution
6 states
SevereFDA (Devices)·Z-0680-2022·2022-03-09
Celltrion DiaTrust COVID-19 Rapid Test Kits Recalled for Unauthorized Clinical Use
Celltrion USA recalled COVID-19 rapid test kits (DiaTrust) in a Class I action. The kits are labeled for research use only, but the firm assured distributors they could be used for clinical diagnosis, which is not authorized.
Product
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0663-2022·2022-03-09
Philips Respironics V60 Plus Ventilators with Defective Adhesive Recalled
Respironics California is recalling 294 V60 Plus ventilators assembled with expired adhesive. The adhesive may fail, causing the bracket to loosen and damage capacitors, potentially stopping ventilation delivery.
Product
Philips Respironics V60 Plus Ventilator Part Number 1138747
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-0627-2022·2022-02-23
Arrow-Trerotola Percutaneous Thrombolytic Device catheter tips may separate during use
The FDA is recalling Arrow-Trerotola Percutaneous Thrombolytic Device catheters due to reports of tip separation during use. Approximately 3,668 units were distributed worldwide.
Product
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native a
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0629-2022·2022-02-23
Arrow-Trerotola Percutaneous Thrombolytic Device Set Tip Separation Recall
Teleflex Medical Inc. is recalling Arrow-Trerotola PTD catheter sets due to reported tip separation during use. The device is used for mechanical declotting of vascular access fistulae and grafts.
Product
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fist
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0626-2022·2022-02-23
Arrow-Trerotola Percutaneous Thrombolytic Device Kits Recalled for Tip Separation
Teleflex is recalling Arrow-Trerotola Percutaneous Thrombolytic Device kits worldwide due to reports of tip separation during use, affecting approximately 1,874 units.
Product
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-65709-C, PT-03009, PT-65709-HS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits me
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0628-2022·2022-02-23
Arrow-Trerotola Thrombolytic Catheter Kits Recalled for Tip Separation During Use
Teleflex Medical is recalling 5,530 Arrow-Trerotola PTD catheter kits due to reports of tip separation during use. The hazard could prevent the device from functioning properly to remove blood clots from dialysis access grafts.
Product
5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-65509-S2 alternative), PT-01000-D (PT-01000-D2 alternative) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjun
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0568-2022·2022-02-23
RNAstill Specimen Collection Kits Recalled Missing FDA 510(k) Clearance
BASE 10 GENETICS INC is recalling RNAstill Molecular Transport Medium Vials and specimen collection kits nationwide because they lack FDA 510(k) clearance. Approximately 455,791 kits were distributed across 18 states.
Product
RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog numbers of RNAstill MTM specimen collection kits: MTM-SW03 with Oropharyngeal swab and MTMSW-05 with Nasopharyngeal swab, packaged 25 specimen collection kits per plastic sleev
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0623-2022·2022-02-23
Arrow-Trerotola Thrombolytic Device Tip Separation During Use Recalled
Teleflex Medical is recalling Arrow-Trerotola PTD kits due to reports of tip separation during use. The affected device is used for declotting dialysis grafts and fistulae.
Product
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-C, The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0624-2022·2022-02-23
Teleflex Arrow-Trerotola Percutaneous Thrombolytic Device PTD Kit recalled for tip separation
Teleflex recalls approximately 1,400 Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) kits due to reports of tip separation during use. The medical device is used for dialysis graft declotting and has been distributed worldwide.
Product
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0622-2022·2022-02-23
Vyaire Medical Ventilators Recalled Due to Potential Ventilation Failure
Vyaire Medical is recalling 4,189 bellavista 1000 and 1000e ventilators worldwide due to potential cessation of ventilation under specific conditions. This FDA Class I recall poses serious risk to patients who depend on these critical care devices.
Product
bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista 1000/1000e ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients, and optionally, infant and neonatal patients.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0625-2022·2022-02-23
Arrow-Trerotola Dialysis Catheter Recalled for Tip Separation During Use
Arrow-Trerotola Over-The-Wire PTD catheters used in dialysis procedures are being recalled due to reports of tip separation during use. The FDA classified this as a Class I recall affecting 1,265 units worldwide.
Product
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of nati
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

1851–1875 of 5038