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

10901–10925 of 40095

HighFDA (Devices)·Z-0779-2023·2023-01-11
Steris Biological Indicators Recalled for Inconsistent Spore Growth
Steris Corporation is recalling VERIFY Dual Species Self-Contained Biological Indicators because some units in lot 230613 fail to consistently promote spore growth, potentially masking failed sterilization cycles.
Product
VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0837-2023·2023-01-11
VITEK 2 Antibiotic Susceptibility Test Kits Recalled for Storage Condition Exceedance
Biomerieux is recalling VITEK 2 REAGENT AST-GN80 test kits due to temperature and time excursions during storage or handling. Product performance cannot be guaranteed for affected units.
Product
VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0812-2023·2023-01-11
FDA Recalls ASTUTE Electronic Quality Control Device for Storage Condition Excursion
Biomerieux Inc. is recalling ASTUTE electronic quality control devices due to temperature and time storage excursion that may compromise product performance in laboratory settings.
Product
ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0840-2023·2023-01-11
Gene-Up Lysis Kit Recalled Due to Storage Condition Violations
Biomerieux Inc is recalling Gene-Up Lysis Kit (Catalog 414057) because storage conditions were exceeded and product performance cannot be guaranteed. Nationwide distribution.
Product
GENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0783-2023·2023-01-11
Listeria Detection Test Strips Recalled for Unreliable Performance
Biomerieux is recalling API Listeria detection test strips that were exposed to temperature and time exceedance during storage. Product performance cannot be guaranteed as a result.
Product
API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0831-2023·2023-01-11
ETEST Clinical Vancomycin Test Kits Recalled Due to Storage Damage
Biomerieux Inc is recalling 7 units of ETEST Clinical Vancomycin VA 256 test kits due to storage temperature excursions that may compromise test performance. Affected kits were distributed nationwide.
Product
ETEST CLINICAL VANCOMYCIN VA 256 US S30, CATALOG 412486
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0792-2023·2023-01-11
VITEK 2 AST-GP67 Reagent Test Kit Recalled Due to Storage Condition Excursion
Biomerieux Inc. is recalling VITEK 2 Antibiotic Susceptibility Test Kits (AST-GP67) due to storage temperature and time conditions exceeding acceptable limits, which cannot guarantee product performance.
Product
VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0835-2023·2023-01-11
VITEK 2 Antibiotic Susceptibility Test Kits Recalled Due to Storage Condition Failures
Biomerieux Inc is recalling VITEK 2 Reagent AST-GN73 test kits nationwide because they were stored outside proper temperature and time ranges, potentially compromising test accuracy.
Product
VITEK 2 REAGENT AST-GN73 TEST KIT 20 CARDS, CATALOG 413404
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0815-2023·2023-01-11
Clinical reagent recalled due to temperature and time excursion
Biomerieux Inc is recalling VITEK MS CLINICAL REAGENT VITEK MS-CHCA due to temperature and time excursions that may prevent product performance guarantees. No illnesses reported.
Product
VITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0862-2023·2023-01-11
Nephrocheck Liquid Control Reagent Recall Due to Storage Condition Violation
Biomerieux is recalling one batch of Nephrocheck Liquid Control Reagent because the product was stored outside proper temperature and time parameters, making performance unreliable.
Product
ASTUTE REAGENT NEPHROCHECK LIQUID CONTROLS KIT US, CATALOG 500013
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0778-2023·2023-01-11
Steris Biological Indicator Lot May Fail to Detect Inadequate Sterilization
Steris Corporation is recalling 338 boxes of VERIFY Dual Species Biological Indicators (Lot #230613) because some units fail to promote spore growth as intended, risking false-negative sterilization test results.
Product
VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Number: S3060 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0798-2023·2023-01-11
VIDAS Listeria 60T Clinical Diagnostic Test Kit Recalled for Storage Failure
Biomerieux recalls VIDAS Listeria 60T test kits (Batch 1009371140) distributed nationwide because storage conditions were exceeded and product performance cannot be guaranteed. Users should discontinue use and contact the manufacturer.
Product
VIDAS CLINICAL VIDAS LISTERIA 60T, CATALOG 30700
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0789-2023·2023-01-11
Medical Device Test Kit Recalled Due to Storage Temperature and Time Excursions
Biomerieux Inc is recalling 14 units of the VITEK 2 REAGENT YST TEST KIT distributed nationwide because temperature and time excursions during storage may compromise the kit's performance.
Product
VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0838-2023·2023-01-11
Medical device test kit recalled due to storage temperature and time excursion
Biomerieux Inc is recalling the VITEK 2 REAGENT AST-GN81 Test Kit after storage conditions exceeded specified ranges, preventing guaranteed product performance. The recall affects 34 units distributed nationwide.
Product
VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS, CATALOG 413438
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0878-2023·2023-01-11
VITROS Intact PTH Reagent Pack recalled for negatively biased measurement results
Ortho-Clinical Diagnostics is recalling VITROS Intact PTH Reagent Packs due to negatively biased measurement results (average -12% shift). The affected reagent lots were distributed worldwide and may produce inaccurate patient test results.
Product
VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) Catalog Number: 6802892
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0827-2023·2023-01-11
ETEST Clinical Meropenem Susceptibility Test Recalled for Storage Condition Failure
Biomerieux is recalling 3 units of ETEST Clinical Meropenem MP 32 susceptibility test (catalog 412401) nationwide due to storage temperature and time exceedances that cannot guarantee product performance.
Product
ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0823-2023·2023-01-11
ETEST Clinical Erythromycin test plates recalled for storage temperature deviation
Biomerieux Inc is recalling ETEST Clinical Erythromycin EM 256 US S30 test plates (batch 1009157090) distributed nationwide. Product performance cannot be guaranteed due to temperature and time storage conditions that exceeded specifications.
Product
ETEST CLINICAL ERYTHROMYCIN EM 256 US S30, CATALOG 412333
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0780-2023·2023-01-11
VERIFY Steam Test Pack Biological Indicators May Fail to Detect Sterilization Failure
Steris is recalling VERIFY Steam Test Packs because biological indicators in affected lots may fail to correctly monitor steam and ethylene oxide sterilization, potentially allowing failed sterilization to go undetected.
Product
VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0848-2023·2023-01-11
VITEK 2 Diagnostic Test Kit Recalled for Storage Parameter Exceedance
Biomerieux is recalling 39 units of a diagnostic test kit because storage temperature and time parameters were exceeded, which may affect test performance and reliability.
Product
VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0793-2023·2023-01-11
Medical Diagnostic Reagent Recalled Due to Storage Temperature Damage
Biomerieux Inc is recalling PREVI COLOR GRAM diagnostic reagent (Catalog 29586) distributed nationwide because improper storage conditions may have degraded product performance.
Product
PREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0811-2023·2023-01-11
TEMPO Control Kit Reagents Recalled Due to Storage Temperature Excursion
Biomerieux is recalling TEMPO REAGENTS TEMPO CONTROL KIT (catalog 80000) due to storage conditions exceeding temperature and time limits, compromising product performance. Batch 1009477900 was distributed nationwide.
Product
TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0829-2023·2023-01-11
Clinical Diagnostic Device Recall: ETEST Rifampicin RI 32 Performance Degradation
Biomerieux Inc is recalling ETEST CLINICAL RIFAMPICIN RI 32 clinical diagnostic strips because temperature and time storage parameters were exceeded, and product performance cannot be guaranteed.
Product
ETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0855-2023·2023-01-11
Medical Device Reagent Recalled for Temperature Storage Condition Failure
Biomerieux Inc recalls GENE-UP Salmonella 2 reagent (Batch 1009407250) after storage temperature and time limits were exceeded, preventing performance guarantee.
Product
GENE-UP REAGENT GENE-UP Salmonella 2, CATALOG 423105
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0786-2023·2023-01-11
Diagnostic Test Kit Recalled Due to Exceeded Storage Conditions
Biomerieux Inc is recalling API STAPH 25 diagnostic test kits because storage conditions exceeded safe temperature and time parameters. Product performance cannot be guaranteed for the affected batch.
Product
API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0849-2023·2023-01-11
Microbiological susceptibility test strips recalled for temperature and time excursion
Biomerieux Inc. is recalling ETEST Clinical Imipenem Relebactam test strips (Catalog 420927) distributed nationwide because the product experienced temperature and time excursions during storage. The manufacturer cannot guarantee the product's test performance.
Product
ETEST CLINICAL IMIPENEM RELEBACTAM IPR US S30, CATALOG 420927
Category
Medical Device
Distribution
Distributed nationwide

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10901–10925 of 40095