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

16526–16550 of 40248

ModerateFDA (Devices)·Z-2931-2020·2020-09-09
Stimwave StimQ Peripheral Nerve Stimulator System Recalled for Non-Functional Component
Stimwave Technologies is recalling six StimQ Peripheral Nerve Stimulator Systems because they contain a non-functional component not referenced in product labeling.
Product
StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2914-2020·2020-09-09
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 could cause holes and tears at the cuffs.
Product
PROTEXIS Latex Micro Surgical Gloves Size 6.5 - 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
ModerateFDA (Devices)·Z-2926-2020·2020-09-09
Exactech Recalls Vantage Total Ankle Tibial Inserts Due to Labeling Error
Exactech is recalling 11 Vantage Total Ankle Tibial Inserts because the labels incorrectly identify the implant size as 3 instead of 4.
Product
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
Category
Medical Device
Distribution
4 states
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
HighFDA (Devices)·Z-2864-2020·2020-09-02
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, 15¿
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2888-2020·2020-09-02
Siemens Recalls Cios Spin and Cios Alpha X-Ray Systems Due to Hardware Error
Siemens is recalling 329 Cios Spin and Cios Alpha mobile X-ray systems due to a hardware error affecting the X-ray Generator with an integrated Energy Storage Unit.
Product
Cios Spin, 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-2895-2020·2020-09-02
Karl Storz Flexible DCI Intubation Fiberscope Recalled for Sterilization Instructions
Karl Storz Endoscopy is recalling 428 Flexible DCI Intubation Fiberscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide on certain scopes to avoid incomplete sterilization.
Product
Flexible DCI Intubation Fiberscope, Part: 11302BDD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2879-2020·2020-09-02
Ortho VITROS XT7600 System Recalled for Potential Mis-positioned Slides
Ortho Clinical Diagnostics is recalling VITROS XT7600 Integrated Systems because slides in Slot 18 may be mis-positioned, leading to erroneous test results.
Product
VITROS XT7600 Integrated System, Product code 6844461
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2868-2020·2020-09-02
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 made of stainless steel instead of the specified cobalt chromium molybdenum alloy.
Product
ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8¿
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2890-2020·2020-09-02
Karl Storz Flexible Intubation Fiberscopes Recalled for Sterilization Instruction Update
Karl Storz Endoscopy is recalling 91 flexible intubation fiberscopes to provide updated sterilization instructions. The update prevents the use of ethylene oxide on specific devices to avoid incomplete sterilization and potential patient infection.
Product
Flexible Intubation Fiberscope, Part: 11301AA1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2870-2020·2020-09-02
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, 10x36, 10-14mm, 15¿
Category
Medical Device
Distribution
0 states

How to read this listing

Filters

16526–16550 of 40248