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

11351–11375 of 27470

HighFDA (Devices)·Z-2035-2021·2021-07-14
Cesarean Birth Drapes Recalled Due to Sticking Plastic Film
Cardinal Health is recalling 1,638 units of Sterile Cesarean Birth Drapes due to defective plastic film that prevents proper unfolding and application during surgery.
Product
Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2037-2021·2021-07-14
Sterile Femoral Angiography Drape Recall Due to Sticking Plastic Film
Cardinal Health is recalling sterile femoral angiography drapes because the plastic film causes drapes to stick, which may prevent proper unfolding and application during procedures.
Product
Sterile Femoral Angiography Drape, Catalog Numbers: a) 29460, b) 29456 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2010-2021·2021-07-14
Luminex Verigene C. difficile Test Kit Recalled for False-Negative Results
Luminex Corporation is recalling 1,261 Verigene Clostridium difficile test kits due to potential for false-negative results. The kits may fail to detect C. difficile infections, potentially delaying diagnosis.
Product
Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2009-2021·2021-07-14
Verigene Enteric Pathogens Test May Return False-Negative Results
Luminex Corporation is recalling Verigene Enteric Pathogens diagnostic tests due to potential for false-negative results, which could miss serious bacterial infections.
Product
Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2027-2021·2021-07-14
Atellica IM 1300 Analyzer Valves Recalled Due to Manufacturing Defect
Siemens is recalling Atellica IM 1300 diagnostic analyzer valves due to a manufacturing defect that may cause leaking and affect test result accuracy.
Product
Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2011-2021·2021-07-14
Verigene Gram Negative Blood Culture Test Recalled for Risk of False-Negative Results
Luminex Corporation is recalling 165 units of the Verigene BC-GNv2 diagnostic test worldwide due to the potential for false-negative results in blood culture testing.
Product
Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2014-2021·2021-07-14
ADVIA Chemistry XPT System Software May Report Incorrect Patient Test Results
Siemens Healthcare is recalling certain ADVIA Chemistry XPT systems with software version 1.4 or lower due to a default mixer failure detection setting that may allow incorrect patient lab results to be reported without alerting clinicians.
Product
The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes. Tests performed using this system are intended for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1999-2021·2021-07-14
Proponent pacemakers recalled for accelerated battery depletion risk
Boston Scientific has recalled certain Proponent pacemaker models worldwide. Hydrogen gas may accumulate inside the device, compromising the capacitor and causing accelerated battery depletion.
Product
Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2041-2021·2021-07-14
Medtronic CoreValve Evolut R Delivery Catheter System Recalled for Actuator Separation
Medtronic is recalling CoreValve Evolut R Delivery Catheter Systems due to reports of actuator separation. The affected devices, manufactured before July 11, 2020, were distributed globally.
Product
CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N;
Category
Medical Device
Distribution
48 states
HighFDA (Devices)·Z-2030-2021·2021-07-14
FREELITE Kappa Free Kit quality control bias recall
The Binding Site Group is recalling the FREELITE Human Kappa Free Kit due to quality control bias of approximately 10% compared to assigned values. Specific lot numbers distributed worldwide are affected.
Product
FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK016.CB, IVD CE, UDI: 05051700012096
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2026-2021·2021-07-14
Siemens Atellica Analyzer Valves Recalled for Manufacturing Defect Risk
Siemens Healthcare Diagnostics has recalled Atellica CH 930 Analyzer valves that may malfunction due to a manufacturing defect. The affected valves may wear and leak over time, potentially impacting diagnostic test accuracy.
Product
Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2007-2021·2021-07-14
Verigene Gram-Positive Blood Culture Test Recalled for Potential False-Negative Results
Luminex Corporation is recalling the Verigene BC-GP blood culture test (Model 20-006-018) due to the potential for false-negative results. Approximately 36,416 units have been distributed worldwide.
Product
Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2006-2021·2021-07-14
Luminex Verigene Respiratory Pathogens Test Recalled for False-Negative Risk
Luminex Corporation is recalling 38,990 Verigene Respiratory Pathogens Flex nucleic acid tests due to potential false-negative results. The tests were distributed worldwide, including throughout the United States.
Product
Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2036-2021·2021-07-14
Cesarean Birth Drapes recalled due to defective plastic film causing sticking
Cardinal Health is recalling Cesarean Birth Drapes due to a plastic film defect. The defect causes the drapes to stick, preventing proper unfolding and application during surgery.
Product
Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442N - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2033-2021·2021-07-14
Sterile Angiography Drapes Recalled Due to Sticking Plastic Film Defect
Cardinal Health is recalling 3,192 units of Sterile Radial/Femoral Angiography Drapes due to sticking plastic film that may prevent proper unfolding and application during surgical procedures.
Product
Sterile Radial/Femoral Angiography Drape, Catalog Number 29529 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2028-2021·2021-07-14
Atellica analyzer valves recalled for manufacturing defect affecting diagnostic accuracy
Siemens recalls Atellica analyzers (CH 930, IM 1300, IM 1600) due to valve manufacturing defects that may cause leaking and affect clinical test result accuracy.
Product
Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2013-2021·2021-07-14
Randox RX Imola Analyzer Software Freeze Recall - 50 Units Affected
Randox recalls 50 RX Imola Analyser units nationwide and in Puerto Rico due to software freezing that prevents test results from displaying.
Product
Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2043-2021·2021-07-14
CoreValve Evolut PRO PLUS Delivery Catheter Systems recalled for actuator separation
Medtronic is recalling CoreValve Evolut PRO PLUS Delivery Catheter Systems due to reports of actuator separation that could affect proper deployment of these cardiac devices.
Product
CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US;
Category
Medical Device
Distribution
48 states
HighFDA (Devices)·Z-2004-2021·2021-07-14
GE Healthcare Revolution CT collimator blade malfunction causing radiation dose variance
GE Healthcare is recalling Revolution CT systems where a collimator blade malfunction may cause x-ray radiation doses to be delivered in amounts larger or smaller than prescribed.
Product
Revolution CT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2024-2021·2021-07-14
Vivorte Bone Void Filler Recalled for Incorrect Expiration Date
Vivorte, Inc. is recalling Trabexus EB bone filler due to an incorrect expiration date on product labels. The label shows expiration of 02-15-2019, but the actual expiration is 12-18-2018.
Product
Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2002-2021·2021-07-14
VALITUDE CRT-P Pacemaker Recalled Due to Potential Accelerated Battery Depletion
Boston Scientific VALITUDE CRT-P pacemakers (models U125 and U128) may experience hydrogen release that compromises the capacitor, causing accelerated battery depletion. Patients should consult their healthcare provider.
Product
VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2001-2021·2021-07-14
Altrua 2 Pacemakers at Risk from Hydrogen-Induced Battery Failure
Boston Scientific is recalling 2,952 Altrua 2 pacemaker units (models S701, S702, S722) distributed worldwide due to hydrogen release that can damage the capacitor and accelerate battery depletion.
Product
Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2032-2021·2021-07-14
Nonsterile Femoral Angiography Drapes Recalled Due to Sticking Plastic Film Defect
Cardinal Health is recalling 26,250 units of Nonsterile Femoral Angiography Drapes due to a manufacturing defect causing the drapes to stick and preventing proper application. This may compromise surgical site protection.
Product
Nonsterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525N - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2042-2021·2021-07-14
Medtronic CoreValve Evolut PRO Delivery Catheter Actuator Separation Recall
Medtronic is recalling 67,339 CoreValve Evolut PRO Delivery Catheter Systems manufactured before July 11, 2020, due to reports of actuator separation that could affect device function.
Product
CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16;
Category
Medical Device
Distribution
48 states
HighFDA (Devices)·Z-1998-2021·2021-07-14
Essentio Pacemaker Models Recalled for Potential Battery Depletion Risk
Boston Scientific is recalling six Essentio pacemaker models due to a hydrogen release defect that may compromise a critical capacitor and cause accelerated battery depletion. Approximately 31,548 units worldwide are affected.
Product
Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131
Category
Medical Device
Distribution
0 states

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11351–11375 of 27470