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

11976–12000 of 13802

ModerateFDA (Devices)·Z-0926-2022·2022-04-20
Philips Autoclavable Temperature Probes: Updated Cleaning Instructions
Philips is updating instructions for cleaning and disinfecting reusable autoclavable temperature probes due to revisions needed in the disinfection process.
Product
The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s: 21075A, 21076A, 21078A, 989803162621, 989803162631, 989803162641.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0930-2022·2022-04-20
Siemens Atellica CH Fructosamine Reagent Recalled for Potential Carryover
Siemens Healthcare Diagnostics is recalling Atellica CH Fructosamine reagent (lots 211359, 211451) due to potential reagent carryover that could affect diagnostic test accuracy.
Product
Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0901-2022·2022-04-20
IntraSight Mobile IVUS touch screen modules missing required labeling information
IntraSight Mobile IVUS Systems touch screen modules lack required labeling information including device identifier and manufacturer information. Affected units were distributed to healthcare facilities in the US and internationally.
Product
IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-0857-2022·2022-04-13
Signa 1.5T MRI System Recall: Potential Horizontal Image Reversal
GE Healthcare is recalling 10 Signa 1.5T TwinSpeed MRI systems worldwide due to a potential defect where magnetic resonance images may be flipped left to right.
Product
Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0897-2022·2022-04-13
Cardiohelp-i Transport Guard Pin Defect May Prevent Device Opening
Maquet Medical Systems is recalling certain Cardiohelp-i Transport Guard units due to a potential loose cylindrical pin that may jam the locking mechanism. This could prevent the device from opening or cause complete disassembly, potentially delaying critical cardiac support.
Product
Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up t
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0871-2022·2022-04-13
Draeger Babylog VN500 Ventilators Recalled for Cybersecurity Vulnerability
Draeger Medical is recalling Babylog VN500 ventilators for neonatal and pediatric patients due to cybersecurity vulnerabilities. The devices are not equipped against potential cyber threats.
Product
Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight Catalog Number: 8417400
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0860-2022·2022-04-13
GE Healthcare MRI Systems Recalled Due to Potentially Flipped Images
GE Healthcare has recalled 653 SIGNA MRI systems worldwide due to a potential defect that could flip medical images left to right. This could affect diagnostic accuracy in patient care.
Product
1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0870-2022·2022-04-13
Draeger Evita V500 Ventilator Cybersecurity Vulnerability Affects Patient Safety
Draeger Medical is recalling Evita V500 ventilators due to cybersecurity vulnerabilities that could potentially compromise device functionality. Affected units require software remediation.
Product
Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0891-2022·2022-04-13
Abbott ARCHITECT STAT myoglobin calibrators recalled for calibration failure
Abbott is recalling 402 kits of ARCHITECT STAT myoglobin calibrator that failed stability testing and may produce out-of-specification calibration results. The affected calibrators could impact the accuracy of myoglobin measurements used in clinical diagnostics.
Product
ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitative determination of myoglobin in human serum and plasma.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0892-2022·2022-04-13
Unauthorized SARS-CoV-2 Antigen Tests recalled for lack of FDA clearance
WHPM Inc. is recalling approximately 535,755 First SIGN SARS-CoV-2 Antigen Tests distributed in California, Florida, Louisiana, Massachusetts, and Texas. The tests were sold without FDA Emergency Use Authorization or clearance.
Product
First SIGN SARS-CoV-2 Antigen Test
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0859-2022·2022-04-13
GE SIGNA Excite 3T MRI Systems Recalled Over Potential Image Flip
GE Healthcare is recalling 55 SIGNA Excite 3T MRI systems due to potential for images to be flipped left to right, which could affect diagnostic accuracy. The affected systems were distributed worldwide.
Product
SIGNA Excite 3T. Magnetic Resonance Imaging System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0869-2022·2022-04-13
X-ray System Radiation Dose May Exceed Safety Limits in Some Modes
Shimadzu SonialVision safire X-ray systems may emit radiation exceeding federal limits during some fluoroscopic procedures. The manufacturer is addressing installation criteria to prevent potential dose violations.
Product
MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
Category
Medical Device
Distribution
37 states
HighFDA (Devices)·Z-0877-2022·2022-04-13
Panther Fusion GBS Assay Cartridges Recalled for False Negative Results
Hologic is recalling 2,061 Panther Fusion GBS Assay Cartridges because samples at or near the limit of detection may produce false negative results, risking missed diagnosis of group B streptococcus infection.
Product
Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
Category
Medical Device
Distribution
21 states
HighFDA (Devices)·Z-0896-2022·2022-04-13
C-Peptide ELISA Kit Recalled Due to Defective Standards
DRG International recalls its C-Peptide ELISA kit (Catalog # EIA-1293) after the standards were found to have optical density below the required threshold. The defect may cause invalid test runs and delayed patient results.
Product
C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0878-2022·2022-04-13
DeRoyal ST Neonatal Dressing Change Kit recalled for unvalidated manufacturing test methods
DeRoyal Industries is recalling 400 DeRoyal ST Neonatal Dressing Change Kits due to uncertain validation of manufacturing test methods. The recall affects kits distributed to healthcare facilities in Florida, New Jersey, and Tennessee.
Product
DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0865-2022·2022-04-13
Anterior Hip Surgical Kit Recall Due to Potential Sterility Breach
Stradis Medical is recalling Anterior Hip Pack surgical kits due to perforated or torn outer bags that may compromise sterility. No illnesses have been reported.
Product
Anterior Hip Pack - Surgical Kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0737-2022·2022-04-13
Philips StentBoost Live imaging system acquisition malfunction recall
Philips Healthcare is recalling the StentBoost Live R2.0 application due to a software configuration error. The imaging system fails to stop image acquisition automatically, continuing indefinitely while the pedal is pressed instead of stopping after 40 images.
Product
Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0898-2022·2022-04-13
Medline Excelsior Medical Sterile Saline Flush Syringes Recalled for Sterility Failure
Medline Industries is recalling 7,800 Excelsior Medical 10mL Sterile Field Saline Flush syringes due to sterility failure of the exterior syringe surface, which may prevent the product from being safely used on a sterile field.
Product
Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/pouch, 35 pouches/box, 8 boxes/case.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0863-2022·2022-04-13
Stradis Medical Anesthesia Kit Recalled Due to Sterility Breach Risk
Stradis Medical is recalling Lum Lam Custom Pack Anesthesia Kits because the outer bag may be perforated or torn, potentially compromising the kit's sterility. Two lot numbers are affected.
Product
Lum Lam Custom Pack - Anesthesia Kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0864-2022·2022-04-13
Total Knee Surgical Kit Recall Due to Potential Sterility Breach
Stradis Medical is recalling 76 units of Total Knee Surgical Kits with potentially perforated or torn outer bags that may compromise sterility. Distribution occurred in Indiana, Texas, and Pennsylvania.
Product
Total Knee Pack - Surgical Kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0883-2022·2022-04-13
Abbott Alinity m HBV Device Misquantitation of Negative Samples
Abbott Molecular recalled Alinity m HBV Application Specification Files due to potential for incorrect high quantitation results on negative samples, which could affect test accuracy for hepatitis B virus detection.
Product
Alinity m HBV Application Specification File (US and CE)
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0866-2022·2022-04-13
Surgical kit recall due to outer bag perforation and sterility risk
Stradis Medical is recalling 348 units of its Total Joint Pack Surgical Kit due to risk of outer bag tears or perforations that could compromise kit sterility. The recall affects units distributed in Indiana, Texas, and Pennsylvania.
Product
Coryell Memorial Hosp Total, Joint Pack - Surgical Kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0881-2022·2022-04-13
Philips HeartStart HS1 AED Pads: Potential Gel Separation Defect
Philips is recalling adult Smart PADS cartridges for HeartStart HS1 defibrillators due to potential gel separation from the pad backing. Affected pads may have reduced gel contact, potentially affecting device performance.
Product
Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0862-2022·2022-04-13
Neurological surgical kits may have compromised packaging sterility
Stradis Medical is recalling Surgicare Neuro Pack neurological kits because the outer bag may be perforated or torn, potentially compromising product sterility. 176 units were distributed in Indiana, Texas, and Pennsylvania.
Product
Surgicare Neuro Pack - Neurological Kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0816-2022·2022-04-13
CT Scanner Dose Display Shows Inaccurate Values in Certain Situations
GE Healthcare Revolution CT scanners display inaccurate radiation dose values in certain situations. This could affect clinical dosing decisions during patient scans.
Product
Revolution CT, Revolution CT ES
Category
Medical Device
Distribution
Distributed nationwide

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