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

1951–1975 of 5111

SevereFDA (Devices)·Z-2244-2021·2021-08-25
Argyle UVC Insertion Tray Recalled for Safety Scalpel Locking Defect
Cardinal Health's Argyle UVC Insertion Tray, used for neonatal umbilical catheter insertion, lacks proper instructions for the included Safety Scalpel N11. Once locked, clinicians cannot unlock it, potentially delaying critical treatment.
Product
Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of neonate. Product Code: 43201
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2195-2021·2021-08-18
HeartWare HVAD Implant Kit Recalled Over Higher Mortality Rates
Medtronic recalled the HeartWare HVAD Implant Kit due to higher rates of neurological adverse events and mortality compared to other left ventricular assist devices. The pump may also fail to restart.
Product
HeartWare HVAD Implant Kit, REF MCS1705PU
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2192-2021·2021-08-18
HeartWare HVAD System Recalled Due to Higher Mortality Rates
Medtronic is stopping the HVAD System due to observational data showing higher mortality rates and neurological adverse events compared to other cardiac assist devices. The internal pump may also delay or fail to restart.
Product
HeartWare HVAD Driveline Extension Cable, REF 100
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2188-2021·2021-08-18
FDA Recalls HeartWare HVAD Pump Implant Kit for Neurological Events and Mortality
Medtronic is recalling the HeartWare HVAD Pump Implant Kit due to higher rates of neurological adverse events and mortality compared to other heart pump devices. The pump may also delay or fail to restart.
Product
HeartWare HVAD Pump Implant Kit, REF 1103
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2197-2021·2021-08-18
Heartware HVAD Pump Accessories Recalled Over Increased Mortality and Device Failures
Heartware is recalling HVAD Pump Accessories due to clinical data showing higher rates of neurological adverse events and mortality compared to other left ventricular assist devices, and reports of pump malfunctions.
Product
HeartWare HVAD Pump Accessories, REF MCS1753AK
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2196-2021·2021-08-18
Heartware HVAD ventricular assist device recalled due to mortality risk
Medtronic recalled the Heartware HVAD Outflow Graft worldwide due to higher rates of neurological events and mortality compared to other left ventricular assist devices, plus pump restart failures.
Product
HeartWare HVAD Outflow Graft, REF MCS1725OG
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2194-2021·2021-08-18
HeartWare HVAD Heart Pump Recalled for Neurological Events and Mortality
Medtronic is recalling the HeartWare HVAD heart pump implant due to higher rates of neurological adverse events and mortality compared to other devices. The internal pump may also delay or fail to restart.
Product
HeartWare HVAD Implant Kit, REF 1104JP
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2193-2021·2021-08-18
HeartWare HVAD Driveline Extension Cable Recalled for Cardiac Safety Concerns
Medtronic is recalling the HeartWare HVAD Driveline Extension Cable (443 units) due to higher frequency of neurological adverse events and mortality in clinical comparisons with other heart assist devices. The pump may experience restart delays or failures.
Product
HeartWare HVAD Driveline Extension Cable, REF 100US
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2191-2021·2021-08-18
HeartWare HVAD Pump Implant Kit Recalled for Increased Mortality and Device Failure
Medtronic is recalling 163 HeartWare HVAD Pump Implant Kits distributed worldwide due to higher rates of neurological adverse events, mortality, and pump malfunction compared to other cardiac assist devices.
Product
HeartWare HVAD Pump Implant Kit, REF 1153
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2190-2021·2021-08-18
HeartWare HVAD heart pump implants recalled for neurological events and mortality
Medtronic is withdrawing 4,078 HeartWare HVAD implants worldwide due to higher frequency of neurological adverse events, mortality, and potential pump restart failures compared to other available devices.
Product
HeartWare HVAD Pump Implant Kit, REF 1125
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2110-2021·2021-08-18
Spectrum IQ Infusion System Recalled for Connectivity Errors
Baxter Healthcare Corporation is recalling the Spectrum IQ Infusion System due to system errors causing pump connectivity failures following certain network configuration changes.
Product
Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2165-2021·2021-08-18
Spectrum IQ Infusion Pump Safety Software Recalled for Drug Identifier Mismatch
Baxter is recalling Dose IQ Safety Software for Spectrum IQ Infusion Pumps due to a software defect that creates a mismatch between displayed drug names and the device's drug library. This could lead to incorrect medication administration.
Product
Dose IQ Safety Software used with Spectrum IQ Infusion Pump
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2189-2021·2021-08-18
Heart Pump Device Recalled for Increased Mortality and Device Failure
Medtronic is recalling the HeartWare HVAD left ventricular assist pump after observational data showed higher rates of neurological adverse events and mortality compared to alternative devices, plus reports of pump restart failure.
Product
HeartWare HVAD Pump Implant Kit, REF 1104
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2204-2021·2021-08-18
Infusion Pump Module Bezel Repair Parts Recalled for Infusion Hazards
BioMedical Equipment Service Co (BMES) recalls bezel repair parts for Alaris Infusion Pump Module Model 8100. Non-original parts may crack or separate, causing free flow, over-infusion, under-infusion, or interruption of infusion.
Product
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-2157-2021·2021-08-04
Zippie Voyage Early Intervention Stroller Seating System May Detach
Sunrise Medical recalls Zippie Voyage early intervention strollers because the seating system may unexpectedly detach and fall, causing injury. Approximately 9,865 devices are affected.
Product
Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for a child or small adult not to exceed 75 pounds.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2005-2021·2021-08-04
Recirculator 8.0s Disposable Lavage Kit recalled for potential aluminum ion release
Eight Medical International BV is recalling the Recirculator 8.0s Disposable Lavage Kit due to potential aluminum ion release during warming therapy that may expose patients under certain use conditions.
Product
Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion System intended to raise the temperature of the thoracic or peritoneal cavity to a target temperature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2158-2021·2021-08-04
Zippie Voyage Early Intervention Stroller Seating System Detachment
Sunrise Medical is recalling the Zippie Voyage early intervention stroller due to unexpected seating system detachment that can cause falls and injury. Approximately 4,741 devices are affected worldwide.
Product
Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for a child or small adult not to exceed 75 pounds.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2074-2021·2021-07-28
Philips Respironics V60 Plus Ventilator software defect reduces oxygen delivery to patients
Respironics V60 Plus Ventilators (software versions 3.00 and 3.10) may reduce oxygen flow below clinical settings, risking oxygen desaturation and hypoxemia in mechanically ventilated patients.
Product
Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2073-2021·2021-07-28
Philips Respironics V60 Ventilator Flow Rate Reduction Safety Defect
Philips Respironics V60 ventilators with High Flow Therapy software versions 3.00 and 3.10 may reduce oxygen delivery below prescribed levels when pressure limits are reached, risking oxygen desaturation.
Product
Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: pat
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1974-2021·2021-07-21
Philips Respironics ventilators recalled for degrading foam and chemical hazards
Philips Respironics ventilators are recalled because foam components may degrade and release particles and chemicals that patients could inhale.
Product
SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2018-2021·2021-07-21
Boston Scientific INGENIO CRT-P Pacemakers Recalled for Battery Defect
Boston Scientific is recalling INGENIO CRT-P pacemakers that may develop high internal battery impedance, causing unexpected device resets and Safety Mode activation. Affected devices require replacement.
Product
INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2017-2021·2021-07-21
VITALIO DR EL Pacemakers Recalled Due to Battery-Related Device Resets
Boston Scientific is recalling VITALIO DR EL pacemakers with Extended Life batteries due to a latent battery condition that may cause unexpected device resets and Safety Mode activation later in device life.
Product
VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1956-2021·2021-07-21
Philips Respironics Continuous Ventilators Recalled for Foam Degradation Risk
Philips Respironics is recalling approximately 255,810 continuous ventilators because polyurethane foam may degrade into particles that could be inhaled or ingested, or release chemicals.
Product
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1957-2021·2021-07-21
Philips Respironics BiPAP ventilators recalled for foam degradation and off-gassing
Philips Respironics BiPAP ventilators' polyurethane foam may degrade into particles that could be inhaled or ingested, or off-gas certain chemicals. About 8,047 devices worldwide are affected.
Product
A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2016-2021·2021-07-21
INGENIO DR EL Pacemakers Recalled: Defective Battery May Trigger Safety Mode
Dual chamber INGENIO DR EL pacemakers with Extended Life batteries may develop high internal impedance, causing devices to enter Safety Mode later in life. Affected patients should contact their healthcare provider about replacement.
Product
INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
Category
Medical Device
Distribution
0 states

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1951–1975 of 5111