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

13426–13450 of 13837

HighFDA (Devices)·Z-2111-2021·2021-07-28
Ultrasound Imaging Software Recalled for Inaccurate Measurement Estimates
Caption Health recalled ultrasound imaging software version 1.2.0 due to a bug that includes unintended video frames in its analysis, potentially resulting in incorrect automated ejection fraction and image quality score estimates. The recall affects approximately 15 systems distributed across five U.S. states.
Product
Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0)
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-2095-2021·2021-07-28
Infant Heel Warmer Recalled Due to Risk of Rupture and Contents Splashing
Cardinal Health is recalling 2.9 million infant heel warmers that may rupture or leak during activation, potentially splashing heated contents onto infants' eyes or skin and causing rash, burn, or inflammation.
Product
Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU MH00002N The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2106-2021·2021-07-28
Cell Marque MSH6 Antibody Recalled for Distribution Without FDA Clearance
Cell Marque Corporation is recalling Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody because the product was distributed as an in-vitro diagnostic device without FDA clearance.
Product
Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-2103-2021·2021-07-28
Knee Prosthesis Recall: Packaging Mixup May Cause Wrong Size Implantation
Encore Medical recalls DJO Surgical EMPOWR 3D knee prosthetic components because packaging labels may not match the product inside, risking implantation of incorrect prosthesis sizes.
Product
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2086-2021·2021-07-28
Medical dialysis concentrates recalled for freezing temperature exposure
Fresenius Medical Care recalls Citrasate and NaturaLyte hemodialysis acid concentrates due to exposure to freezing temperatures during refrigerated truck transport. The affected products were distributed exclusively to Texas.
Product
Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for us
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2090-2021·2021-07-28
Fresenius Sterile Stay Safe Cap Recalled for Freezing Temperature Exposure
Fresenius recalls 39 cases of Sterile Stay Safe Caps (lot numbers B1ZH191, B1ZI092) distributed to Texas due to exposure to freezing temperatures during refrigerated truck malfunction, which may have compromised product sterility.
Product
050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe¿ Cap is equivalent to that for the Fresenius Stay Safe Cap and is as follows: Indications for Use Fresenius Sterile Stay Safe¿ Cap is intended to be used for closure of the s
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2129-2021·2021-07-28
Exactech Hip Implant Liners Recalled for Premature Wear Risk
Exactech Connexion GXL hip implant liners are recalled due to risk of edge-loading and premature wear in certain patient configurations. No injuries have been reported.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-40-XX, Novation GXL Liner, +5mm Lateralized, 40mm. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2128-2021·2021-07-28
Hip Implant Liners Recalled Due to Premature Wear Risk
Exactech Connexion GXL acetabular polyethylene liners used in hip replacement systems are recalled due to risk of edge-loading and premature wear in certain patients. The 89,050 affected units were distributed nationwide.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-36-XX, Novation GXL Liner, +5mm Lateralized, 36mm. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2126-2021·2021-07-28
Exactech GXL Hip Implant Liners Recalled for Premature Wear Risk
Exactech is recalling its Connexion GXL acetabular polyethylene liners used in hip implants because they may experience edge-loading and premature wear in certain patient configurations and surgical positioning. A total of 89,050 units were distributed nationwide.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-28-XX, Novation GXL Liner, +5mm Lateralized, 28mm; and Novation GXL Liner, +5mm Lateralized, G0, 22mm ID. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide
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-2124-2021·2021-07-28
Hip implant liners recalled for edge-loading and premature wear
Exactech Connexion GXL hip implant liners are recalled due to risk of edge-loading and premature wear in certain configurations. About 89,050 units distributed nationwide are affected.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 134-28-XX, Acumatch GXL, Ext Cov Liner, 28mm. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2113-2021·2021-07-28
Exactech Connexion GXL hip implant liners recalled due to premature wear risk
Exactech is recalling 89,050 Connexion GXL hip implant liners distributed nationwide due to a risk of edge-loading and premature wear in certain patient implant configurations.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-32-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2118-2021·2021-07-28
Hip implant polyethylene liners recalled due to premature wear risk
Exactech Connexion GXL acetabular liners used in hip implants are recalled due to risk of edge-loading and premature wear in patients with specific implant configurations and surgical positioning.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch GXL 0 Degree Liner, 36mm; and Novation GXL Liner, Neutral, 36mm. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2093-2021·2021-07-28
Laboratory Information System SoftGenomics Recalled for Displaying Incorrect Results
SoftGenomics version 4.1.15.6, a laboratory information system used in clinical laboratories, has been recalled due to reports that the software displays incorrect results and PDF reports do not match the hospital information system.
Product
SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and tra
Category
Medical Device
Distribution
1 state
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
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
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-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-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-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-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-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

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13426–13450 of 13837