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

13501–13525 of 13837

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-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
47 states
HighFDA (Devices)·Z-2003-2021·2021-07-14
VISIONIST CRT-P Pacemaker Recalled Due to Battery Depletion Risk
Boston Scientific has recalled 5,920 VISIONIST CRT-P pacemakers due to hydrogen gas buildup that can compromise a capacitor and cause accelerated battery depletion. Affected patients should contact their healthcare provider for device evaluation.
Product
VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2040-2021·2021-07-14
FilmArray Pneumonia Diagnostic Kits Recalled for False Negative Results
BioFire Diagnostics is recalling 3,559 FilmArray Pneumonia Panel plus test kits globally due to stability failures causing increased false negative results between 6 and 12 months after manufacturing, potentially missing pneumonia diagnoses.
Product
FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit) Part No: RFIT-ASY-0142 / UDI: 00815381020321 (6 test kit)
Category
Medical Device
Distribution
47 states
HighFDA (Devices)·Z-2038-2021·2021-07-14
Angiography and Cesarean Birth Drapes recalled due to sticking defect
Cardinal Health is recalling Nonsterile Femoral Angiography and Cesarean Birth Drapes (15,360 units) because plastic film causes sticking that may prevent proper unfolding and application.
Product
Nonsterile Femoral Angiography Drape, Catalog Numbers: a) 29460NB, b) 29456NB - 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-2034-2021·2021-07-14
Nonsterile Radial/Femoral Angiography Drapes Recalled for Sticking Defect
Cardinal Health is recalling 13,426 units of Nonsterile Radial/Femoral Angiography Drape (Catalog #29529N) due to a manufacturing defect where plastic film causes the drapes to stick, preventing proper unfolding and application in surgical settings.
Product
Nonsterile Radial/Femoral Angiography Drape, Catalog Number 29529N - 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-2039-2021·2021-07-14
FilmArray Pneumonia Panel Kits Recalled Due to Shelf-Life False Negatives
BioFire Diagnostics is recalling FilmArray Pneumonia Panel test kits globally due to stability failures that increase false negative results between 6 and 12 months of shelf life.
Product
FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 00815381020185 (6 test kit)
Category
Medical Device
Distribution
47 states
HighFDA (Devices)·Z-1992-2021·2021-07-14
HydraVision Fluoroscopy System Displays Inaccurate Radiation Dose Measurements
LIEBEL-FLARSHEIM is recalling HydraVision Digital Imaging Systems because the displayed radiation doses are higher than actual delivered doses, potentially affecting clinical decision-making and radiation safety.
Product
HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
Category
Medical Device
Distribution
Distributed nationwide
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-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-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
47 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-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-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-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-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-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
47 states
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-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-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-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-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-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
ModerateFDA (Devices)·Z-2023-2021·2021-07-14
GE Revolution CT scanner user interface fails to confirm scan group names
The GE Revolution CT imaging system's user interface fails to update and confirm when scan group names contain characters other than letters, numbers, or spaces, potentially causing user uncertainty during scan setup.
Product
The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either witho
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2012-2021·2021-07-14
ACE Control Set stability claim failure requires updated handling instructions
Sentinel CH SpA is recalling ACE Control Set diagnostic control kits due to stability claims after reconstitution that do not meet specified requirements. Updated handling instructions have been provided to affected users.
Product
ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001
Category
Medical Device
Distribution
Distributed nationwide

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13501–13525 of 13837