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 the agency’s own highest classification or reported deaths or serious injuries, 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 27470

HighFDA (Devices)·Z-2133-2021·2021-07-28
Hip implant acetabular liners recalled for edge-loading and premature wear
Exactech Connexion GXL acetabular polyethylene liners for hip implants are recalled due to risk of edge-loading and premature wear in certain patient configurations and implant positions. Approximately 89,050 units distributed nationwide are affected.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-32-XX, Acumatch GXL 15 Degree Liner, 32mm; Novation GXL Liner, Lipped Ant, 32mm; and Novation GXL Liner, Lipped, 32mm. Orthopedic hip implant component.
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
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…
Category
Medical Device
Distribution
0 states
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-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-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-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-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-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-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-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-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…
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
HighFDA (Devices)·Z-2047-2021·2021-07-21
Canon Vantage Galan 3T MRI System Recalled for Fire Risk
Canon Medical System is recalling Canon Vantage Galan 3T MRI systems due to a component that does not meet flame retardancy standards, which could result in smoke or fire. The recall affects units distributed nationwide.
Product
Canon Vantage Galan 3T, REF: MRT-3020 - 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 system is capable of non-contrast…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2048-2021·2021-07-21
Hang&Go Hyperthermic Perfusion Kit Recall Due to Sterilization Failure
RanD S.r.l. is recalling Hang&Go hyperthermic perfusion kits due to a sterilization process failure that may have left some units non-sterile. The recall affects 72 kits distributed to Florida, Illinois, Tennessee, and Wisconsin.
Product
Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-2044-2021·2021-07-21
Toshiba Vantage MRI System Recalled for Flame Retardancy Defect
Canon Medical's Toshiba Vantage Tiitan 1.5T MRI systems are being recalled due to a component that does not meet flame retardancy standards. The defect could result in smoke or fire. Affected units were distributed nationwide.
Product
Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI System, REF: MRT-1504 - 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…
Category
Medical Device
Distribution
Distributed nationwide
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-2077-2021·2021-07-21
Urethral bulking system needles recalled due to sterility assurance failure
Axonics is recalling BULKAMID urethral bulking system needles that may not have been adequately sterilized despite sterile labeling. Unsterilized surgical needles pose infection risk.
Product
BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2062-2021·2021-07-21
MRI System User Interface Error May Cause Incorrectly Flipped Images
GE Healthcare SIGNA Voyager MRI systems may display flipped or incorrectly annotated diagnostic images due to button confusion on the system interface. 541 devices are affected worldwide.
Product
SIGNA Voyager, Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2050-2021·2021-07-21
EcoFit Cementless Acetabular Cup Plugs May Loosen During Hip Surgery
Central hole cover plugs on EcoFit cementless acetabular cups may come loose during surgical implantation, potentially extending operation time or requiring revision surgery. Fifty-one units in Florida and Texas are affected.
Product
EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless 46mm dia incl. central hole cover; 02200048 /EcoFit cup cementless 48mm dia incl. central hole cover; 02200050 /EcoFit cup cementless 50mm dia incl. central hole cover; 02200052 /EcoFit…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2078-2021·2021-07-21
Unifine Pentips Plus pen needles distributed with incorrect needle sizes
Owen Mumford USA is recalling Unifine Pentips Plus pen needles because two cases of 4mm needles were mistakenly packaged as 8mm needles, which could result in patients receiving incorrect needle sizes for their insulin pens.
Product
Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2065-2021·2021-07-21
GE SIGNA HDxt MRI System: Orientation Button Error Risk
GE Healthcare recalls 91 SIGNA HDxt MRI systems worldwide. The Patient Orientation button may be accidentally clicked instead of Save RX, potentially causing diagnostic images to be incorrectly oriented or flipped.
Product
1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2071-2021·2021-07-21
Arrow Temporary Pacing Catheter Distributed Without FDA 510K Clearance
Arrow International is recalling its Temporary Pacing Catheter/Introducer Kit because it was marketed without required FDA 510K clearance. Approximately 15 units were distributed in multiple U.S. states.
Product
Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product Code: AI-07155-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2054-2021·2021-07-21
GE Healthcare SIGNA Pioneer MRI scanner control panel button design issue
GE Healthcare recalls 460 SIGNA Pioneer MRI scanners worldwide due to a control panel button design flaw. Patient Orientation button may be accidentally clicked instead of Save RX, potentially resulting in incorrect image annotation or orientation.
Product
SIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Category
Medical Device
Distribution
0 states

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11301–11325 of 27470