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

16301–16325 of 39988

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
ModerateFDA (Devices)·Z-2928-2020·2020-09-09
Stimwave StimQ Peripheral Nerve Stimulator Recalled for Non-Functional Component
Stimwave Technologies is recalling 2,444 StimQ Peripheral Nerve Stimulator Systems because they contain a non-functional component not referenced in product labeling.
Product
StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - 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…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2924-2020·2020-09-09
Randox Pancreatic Amylase Reagents Recalled for Performance Failure
Randox Laboratories is recalling specific batches of Pancreatic Amylase reagents because they failed to meet performance claims prior to their September 2020 expiry date.
Product
Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-2923-2020·2020-09-09
Randox Laboratories Recalls Amylase Reagents Due to Performance Failures
Randox Laboratories is recalling specific batches of Amylase reagents because they failed to meet performance claims prior to their September 2020 expiry date.
Product
Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-2911-2020·2020-09-09
C.A. Greiner HOLDEX Plastic Cannula Recalled for Sample Leakage
C.A. Greiner & Sohne is recalling 390,000 units of HOLDEX Plastic Cannulas (Lot A19073FK) because sample may leak from the sleeve covering the needle.
Product
Plastic Cannula HOLDEX Item # 450216 - Product Usage: - Product Usage: It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula ports.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2929-2020·2020-09-09
Stimwave StimQ Peripheral Nerve Stimulator System Recalled for Non-Functional Component
Stimwave Technologies is recalling 1,550 StimQ Peripheral Nerve Stimulator Systems because they contain a non-functional component not referenced in product labeling.
Product
StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO 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-2932-2020·2020-09-09
Stimwave StimQ Peripheral Nerve Stimulator Recalled for Non-Functional Component
Stimwave Technologies is recalling 2,197 StimQ Peripheral Nerve Stimulator units because they contain a non-functional component not listed in the product labeling.
Product
StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-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-2936-2020·2020-09-09
Diasorin Recalls Parvovirus B19 IgG EIA Kit Due to Labeling Error
Diasorin Inc. is recalling 615 units of the Parvovirus B19 IgG EIA kit because the printed label inside the box lid contains an incorrect Lot Specific Constant value.
Product
Parvovirus B19 IgG EIA kit Part No. V519IGUS
Category
Medical Device
Distribution
11 states
ModerateFDA (Devices)·Z-2872-2020·2020-09-09
GE Healthcare Recalls OEC 9800 and 9900 C-Arms for Dose Display Issues
GE Healthcare is recalling 221 OEC 9800 and 9900 C-Arms because field service engineers changed the dose display to DAP, violating FDA regulations requiring AKR/CAK.
Product
The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2933-2020·2020-09-09
Stimwave StimQ Peripheral Nerve Stimulator Recalled for Non-Functional Component
Stimwave Technologies is recalling 13 StimQ Peripheral Nerve Stimulator units because they contain a non-functional component not listed in the product labeling.
Product
StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2930-2020·2020-09-09
Stimwave StimQ Peripheral Nerve Stimulator Recalled for Non-Functional Component
Stimwave Technologies is recalling 1,424 StimQ Peripheral Nerve Stimulator units because they contain a non-functional component not referenced in product labeling.
Product
StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - 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…
Category
Medical Device
Distribution
Distributed nationwide
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

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16301–16325 of 39988