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

13076–13100 of 27471

HighFDA (Devices)·Z-2916-2020·2020-09-09
Cardinal Health Recalls PROTEXIS Latex Micro Surgical Gloves Due to Defects
Cardinal Health 200, LLC is recalling PROTEXIS Latex Micro Surgical Gloves because a degradation defect may cause holes or tears at the cuffs.
Product
PROTEXIS Latex Micro Surgical Gloves Size 7.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2918-2020·2020-09-09
Cardinal Health Recalls PROTEXIS Latex Micro Surgical Gloves Due to Defects
Cardinal Health 200, LLC is recalling PROTEXIS Latex Micro Surgical Gloves because a degradation defect may cause holes and tears at the cuffs.
Product
PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2913-2020·2020-09-09
Cardinal Health Recalls PROTEXIS Latex Micro Surgical Gloves Due to Defects
Cardinal Health is recalling PROTEXIS Latex Micro Surgical Gloves because a degradation defect may cause holes and tears at the cuffs.
Product
PROTEXIS Latex Micro Surgical Gloves Size 6.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2934-2020·2020-09-09
Siemens Symbia S and T Series SPECT Systems Recalled for Detector Motion
Siemens Medical Solutions is recalling 412 Symbia S and T Series SPECT systems due to a defect that may cause unintended slow motion of the detectors.
Product
Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2920-2020·2020-09-09
Remel Bordetella pertussis Agglutinating Serum Recalled for False Negative Results
Remel Europe Ltd. is recalling Thermo Scientific Remel Bordetella pertussis Agglutinating Serum because it may produce false negative results for serotypes 1 and 3.
Product
Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI: 05056080501826 - Product Usage: Bordetella antisera are suitable for use in slide agglutination tests to serologically identify Bordetella pertussis and Bordetella parapertussis…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2915-2020·2020-09-09
Cardinal Health Recalls PROTEXIS Latex Micro Surgical Gloves Due to Defects
Cardinal Health 200, LLC is recalling PROTEXIS Latex Micro Surgical Gloves because a degradation defect may cause holes and tears at the cuffs.
Product
PROTEXIS Latex Micro Surgical Gloves Size 7.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2922-2020·2020-09-09
Teleflex Pleur-evac Thoracic Catheters Recalled for Potential Sterility Issue
Teleflex Medical Inc is recalling Pleur-evac Thoracic Catheters due to a potential sterility issue. The recall affects 700 units distributed across 25 US states.
Product
Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to be used in any surgical procedure requiring attachment to a Chest Drainage device. The thoracic catheter is indicated for use less than 30 days.
Category
Medical Device
Distribution
27 states
HighFDA (Devices)·Z-2935-2020·2020-09-09
CareFusion Recalls BD Alaris EtCO2 Modules Due to Monitoring Interruption Risk
CareFusion 303, Inc. is recalling 680 BD Alaris EtCO2 modules because a component defect may interrupt patient monitoring.
Product
BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2) and respiratory rate (RR). The EtCO2 module and disposables are indicated for use with intubated…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2912-2020·2020-09-09
Cardinal Health Recalls PROTEXIS Latex Micro Surgical Gloves Due to Defects
Cardinal Health is recalling PROTEXIS Latex Micro Surgical Gloves because a degradation defect could cause holes or tears at the cuffs, compromising barrier protection.
Product
PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2917-2020·2020-09-09
Cardinal Health Recalls PROTEXIS Latex Micro Surgical Gloves Due to Defects
Cardinal Health is recalling PROTEXIS Latex Micro Surgical Gloves because a degradation defect may cause holes and tears at the cuffs.
Product
PROTEXIS Latex Micro Surgical Gloves Size 8.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2856-2020·2020-09-02
Globus Medical Recalls ALTERA Spacers Due to Incorrect Material Composition
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may be made of stainless steel instead of the specified cobalt chromium molybdenum alloy.
Product
ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2854-2020·2020-09-02
Globus Medical Recalls ALTERA Spacers with Incorrect Stainless Steel Components
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.
Product
ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2850-2020·2020-09-02
FDA Recalls Specific Lots of ALTERA Spacer Implants Due to Material Error
Globus Medical is recalling specific lots of ALTERA Spacer implants because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.
Product
ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile)
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2880-2020·2020-09-02
Biosense Webster Recalls CARTO 3 System Software Due to Defect
Biosense Webster is recalling the CARTO 3 System software due to a defect that may cause tag sites to disappear, potentially leading to cardiac perforation.
Product
CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardiac electrophysiological (EP) procedures. The system provides information about the electrical activity of the heart and about catheter…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2831-2020·2020-09-02
Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope Corporation is recalling specific lots of Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall affects 1,275 kits distributed worldwide.
Product
Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0684-00-0294-01U, 0684-00-0294-02, 0684-00-0294-02U- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2858-2020·2020-09-02
Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.
Product
ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2869-2020·2020-09-02
FDA Recalls Specific Lots of ALTERA Spacers Due to Material Defect
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.
Product
ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2871-2020·2020-09-02
Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been made with stainless steel instead of the specified cobalt chromium molybdenum alloy.
Product
ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15¿
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2887-2020·2020-09-02
Siemens Recalls Cios Alpha and Spin X-Ray Systems for Hardware Error
Siemens is recalling 329 Cios Alpha and Cios Spin mobile X-ray systems due to a hardware error affecting the X-ray generator after a previous repair.
Product
Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-2861-2020·2020-09-02
Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.
Product
ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8¿
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2883-2020·2020-09-02
GE Healthcare Recalls CARESCAPE R860 Ventilators Due to Oxygen Sensor Issue
GE Healthcare is recalling 2,277 CARESCAPE R860 ventilators because a potential oxygen sensor issue may cause inaccurate FiO2 readings.
Product
CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and Volume.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2859-2020·2020-09-02
Globus Medical Recalls Specific Lots of ALTERA Spacers
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.
Product
ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8¿
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2844-2020·2020-09-02
Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall covers 11,555 kits distributed worldwide.
Product
Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0608 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2903-2020·2020-09-02
Neurovision Cobra EMG ET Tube Recalled for Insulating Material Softening
Neurovision is recalling Cobra x5 EMG ET tubes because the insulating material may soften and damage, potentially stopping EMG signal transmission.
Product
Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S-5, Rx Only, Sterile EO UDI: B006:TE700S52$$7050918B - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2853-2020·2020-09-02
Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.
Product
ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8¿
Category
Medical Device
Distribution
0 states

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13076–13100 of 27471