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

13401–13425 of 13802

HighFDA (Devices)·Z-2096-2021·2021-07-28
Mediana Vital Signs Monitor May Fail to Power Up or Respond
Mediana AVSM3 SNF vital signs monitors may fail to power up or have unresponsive button controls, potentially preventing patient vital sign monitoring. The company is recalling 618 units distributed in Wisconsin.
Product
AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2132-2021·2021-07-28
Exactech Hip Implant Liners Recalled Due to Premature Wear Risk
Exactech is recalling Connexion GXL hip implant liners due to edge-loading and premature wear risk in certain patient configurations. The recall affects 89,050 units distributed nationwide.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX, Novation GXL Liner, 10 Deg Face, 32mm. Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-36-XX, Acumatch GXL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2101-2021·2021-07-28
Stryker Cortoss Bone Augmentation Material Recalled for Temperature Storage Violation
Stryker Spine recalled Cortoss Bone Augmentation Material due to a 12-hour temperature excursion at the distribution center that could have compromised product sterility and efficacy.
Product
Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2109-2021·2021-07-28
Stimulen Collagen Moisturizing Lotion recalled for sterilization audit failure
Southwest Technologies Inc is recalling Stimulen Collagen Moisturizing Lotion, ST9555B (Lot 2104007) due to failure in the sterilization audit process. Approximately 2016 units were distributed to Malaysia.
Product
Stimulen Collagen Moisturizing Lotion, ST9555B
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2108-2021·2021-07-28
Mindray battery cradle may prevent monitor from powering on
Mindray is recalling the 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 and TM80 Telepack physiological monitors. The cradle may prevent the monitor from powering on. Approximately 804 units were distributed in the US and Canada.
Product
3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Telepack (Model Number 115-047565-00 / 120-018867-00). Used with physiological data monitor.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2105-2021·2021-07-28
Cell Marque Rabbit Monoclonal Antibody Distributed Without FDA Clearance
Cell Marque recalled 41 kits of a rabbit monoclonal antibody product distributed for in-vitro diagnostic use without required FDA clearance. The product was distributed in 16 US states.
Product
Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798
Category
Medical Device
Distribution
18 states
ModerateFDA (Devices)·Z-2085-2021·2021-07-28
Liberty Drain Line Recalled for Freezing Temperature Exposure During Transport
Fresenius Medical Care is recalling 6 cases of 026-20036A Liberty Drain Lines distributed in Texas due to exposure to freezing temperatures during refrigerated truck malfunction.
Product
026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2019-2021·2021-07-21
INTUA CRT-P Pacemakers Recalled Due to Battery Degradation Risk
The INTUA CRT-P pacemakers (1,707 units) may develop high internal battery impedance later in device life, causing system resets and triggering Safety Mode. Therapy continues but device replacement is required.
Product
INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1958-2021·2021-07-21
Philips BiPAP A-Series Ventilators Recalled for Foam Degradation Risk
Philips Respironics recalled 72,665 BiPAP A-Series ventilators worldwide. The foam in these devices may degrade into particles that could be inhaled or ingested, and may release chemicals.
Product
A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2020-2021·2021-07-21
Boston Scientific INLIVEN CRT-P Pacemakers Battery Impedance Recall
Boston Scientific recalls dual chamber INGENIO family pacemakers and CRT-Ps with Extended Life batteries that may develop high internal impedance, causing Safety Mode and system resets, requiring device replacement.
Product
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2015-2021·2021-07-21
Boston Scientific ADVANTIO DR EL Pacemakers Recalled for Battery Malfunction
Boston Scientific is recalling ADVANTIO DR EL dual chamber pacemakers and CRT-Ps due to a latent battery condition that may cause system resets and trigger Safety Mode, requiring device replacement.
Product
ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)
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-1972-2021·2021-07-21
Philips Respironics E30 ventilator foam degradation poses inhalation hazard
Philips Respironics E30 ventilators may have polyurethane foam that degrades into particles. These particles can enter the air pathway and be inhaled or ingested by patients, or the foam may off-gas chemicals.
Product
Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbers DSX9999H11, INX9999H19, RINX9999H19 The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for indiv
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-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-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
SevereFDA (Devices)·Z-1973-2021·2021-07-21
Philips Respironics ventilators recalled due to foam degradation and chemical release
Philips Respironics ventilators and respiratory support devices are being recalled because polyurethane foam components may degrade into particles that can be inhaled or ingested, and the foam may release harmful chemicals.
Product
DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, Non-life Supporting The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individu
Category
Medical Device
Distribution
0 states
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-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
HighFDA (Devices)·Z-2045-2021·2021-07-21
Canon 1.5T MRI System Recalled for Flame Retardancy Component Failure
Canon Vantage Tiitan 1.5T MRI Systems with certain serial numbers are recalled due to a component lacking proper flame retardancy, which could result in smoke or fire.
Product
Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this sy
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2061-2021·2021-07-21
SIGNA Artist MRI System Patient Orientation Button May Cause Flipped Images
GE Healthcare is recalling 562 SIGNA Artist MRI systems due to a user interface defect where the Patient Orientation button may be inadvertently clicked instead of the Save RX button, potentially causing images to be incorrectly annotated or flipped.
Product
SIGNA Artist, Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2064-2021·2021-07-21
MRI System Patient Orientation Button May Cause Flipped Images
GE Healthcare's Discovery MR450 1.5T MRI system may inadvertently change patient orientation when users click the wrong button, resulting in flipped or incorrectly annotated images that could affect diagnostic accuracy.
Product
Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2025-2021·2021-07-21
Shoulder prosthesis component distributed with incorrect thickness due to lot swap
Two lots of Aequalis Ascend Flex Shoulder System Reversed Tray components were swapped during distribution, resulting in packages containing components with incorrect thickness.
Product
Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2072-2021·2021-07-21
HeartWare HVAD Pump Implant Kit Impeller Defect Recall
HeartWare HVAD Pump Implant Kit (REF MCS1705PU) recalled because the pump's impeller shroud height does not meet the lower control limit. The device is used for hemodynamic support in patients with advanced heart failure.
Product
HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in pat
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2057-2021·2021-07-21
GE Healthcare SIGNA PET/MR button mix-up causes image orientation errors
GE Healthcare is recalling 71 SIGNA PET/MR imaging devices worldwide. A software issue allows the Patient Orientation button to be accidentally clicked instead of Save RX, resulting in incorrectly annotated or flipped diagnostic images.
Product
SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Category
Medical Device
Distribution
0 states

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13401–13425 of 13802