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

10876–10900 of 40095

HighFDA (Devices)·Z-0905-2023·2023-01-11
Randox Protein Control Material Concentration Decreased, Affecting Quality Control
Randox Laboratories is recalling Liquid Assayed Specific Protein Control Level 3 (catalog PS2684) because the concentration of rheumatoid factor has decreased, causing quality control systems to run outside acceptable ranges and delaying test result reporting.
Product
Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0830-2023·2023-01-11
ETEST Tobramycin Susceptibility Test Recalled for Storage Condition Failure
Biomerieux is recalling ETEST Clinical Tobramycin susceptibility test strips (batch 1009434160) because temperature and storage time conditions were exceeded during distribution. Product performance cannot be guaranteed due to these storage failures.
Product
ETEST CLINICAL TOBRAMYCIN TM 256 US S30, CATALOG 412478
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0834-2023·2023-01-11
VITEK 2 Antimicrobial Susceptibility Test Kits Recalled for Temperature Exposure
Biomerieux is recalling VITEK 2 AST-GN70 test kits nationwide due to temperature and time excursions that may compromise test performance and diagnostic reliability.
Product
VITEK 2 REAGENT AST-GN70 TEST KIT 20 CARDS, CATALOG 413401
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0853-2023·2023-01-11
VITEK 2 AST-GN95 Diagnostic Test Kit Recalled for Performance Failure
Biomerieux is recalling the VITEK 2 AST-GN95 test kit because storage temperature and time exceeded acceptable limits, preventing performance guarantees. Eighty-four units were distributed nationwide.
Product
VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0796-2023·2023-01-11
Measles Antibody Test Kits Recalled Due to Temperature Excursion
Biomerieux Inc recalled VIDAS Measles IgG diagnostic test kits due to temperature and time excursions during storage or transport. Affected batch 1009421810 distributed nationwide; product performance cannot be guaranteed.
Product
VIDAS CLINICAL VIDAS MEASLES IGG 60TESTS, CATALOG 30219
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0775-2023·2023-01-11
Programmable Diagnostic Computer Software Update Addresses Crash Errors
Siemens is updating software in 638 Programmable Diagnostic Computers distributed in the US to fix four software errors that could crash the device or corrupt password storage, potentially delaying diagnostics.
Product
Programmable Diagnostic Computer
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0782-2023·2023-01-11
Beaver Surgical Eye Knife Recalled for Sterile Barrier Compromise
Beaver Visitec is recalling its surgical eye knife (Part 376630) used in cataract procedures due to compromised sterile packaging that may lead to infection. Approximately 599 units have been affected in the US.
Product
Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part Number: 376630
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0828-2023·2023-01-11
ETEST Minocycline Susceptibility Test Affected by Storage Temperature Exceedance
Biomerieux is recalling ETEST CLINICAL MINOCYCLINE MC 256 clinical diagnostic tests nationwide due to storage temperature exceedance that may affect test performance and reliability.
Product
ETEST CLINICAL MINOCYCLINE MC 256 US S30, CATALOG 412407
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0856-2023·2023-01-11
Medical Device Test Kit Recalled Due to Storage Condition Exceedance
Biomerieux Inc. is recalling the VITEK 2 REAGENT AST-N801 TEST KIT nationwide due to storage conditions exceeding acceptable ranges, which cannot guarantee product performance.
Product
VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0868-2023·2023-01-11
VIDAS BRAHMS Procalcitonin Test System Recalled for Storage Condition Failure
Biomerieux is recalling 47 units of the VIDAS BRAHMS Procalcitonin test system (Batch 1009301530) after determining that temperature and time exceedances compromised product performance. Affected devices may produce unreliable diagnostic results.
Product
VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T, CATALOG 30450-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0814-2023·2023-01-11
Biomerieux VITEK MS Clinical Reagent Recall Due to Temperature Excursion
Biomerieux is recalling VITEK MS-DS clinical reagent due to temperature and time conditions that exceeded specification. Thirteen units distributed nationwide cannot guarantee product performance.
Product
VITEK MS CLINICAL REAGENT VITEK MS-DS, CATALOG 410893
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0858-2023·2023-01-11
PPM Lombard TSA Neutralizer Culture Media Recalled for Storage Defect
Biomerieux is recalling 74 units of PPM Lombard Products TSA 3P neutralizer culture media due to temperature and time storage excursions. Product performance cannot be guaranteed.
Product
PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 423723
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0861-2023·2023-01-11
VITEK 2 AST-XN15 Test Kit Recalled for Temperature and Time Storage Failure
Biomerieux Inc. recalls 58 units of the VITEK 2 AST-XN15 Test Kit after storage temperatures exceeded safe limits. Performance cannot be guaranteed. Nationwide US distribution.
Product
VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0817-2023·2023-01-11
ETEST Amikacin Test Strips Recalled for Storage Condition Excursion
Biomerieux is recalling ETEST CLINICAL AMIKACIN AK 256 US S30 test strips (batch 1009209480) because temperature and time storage conditions were exceeded, and product performance cannot be guaranteed.
Product
ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0824-2023·2023-01-11
FDA Recalls ETEST Fluconazole Susceptibility Test due to Storage Excursion
Biomerieux Inc. is recalling ETEST CLINICAL FLUCONAZOLE FL 256 susceptibility testing kits due to storage temperature and time excursions that prevent performance verification. Affected batch 1009172020 is distributed nationwide.
Product
ETEST CLINICAL FLUCONAZOLE FL 256 US S30, CATALOG 412333
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0794-2023·2023-01-11
FDA Recalls Reagent Nozzle Cleaning Solution Due to Storage Temperature Exceedance
Biomerieux Inc is recalling a reagent nozzle cleaning solution (Catalog 29588) because storage temperature and time conditions were exceeded, preventing product performance guarantee.
Product
PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA), CATALOG 29588
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0851-2023·2023-01-11
ETEST Clinical Eravacycline ERV test kit recalled for temperature storage excursion
Biomerieux is recalling ETEST Clinical Eravacycline ERV test kits nationwide after temperature and time storage conditions exceeded acceptable ranges, making product performance unreliable.
Product
ETEST CLINICAL ERAVACYCLINE ERV US S30, CATALOG 421553
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0813-2023·2023-01-11
Culture Medium Recall Due to Temperature Excursion Affecting Product Performance
Biomerieux Inc recalls PPM INDUSTRY COMBOURG LPT BROTH culture medium batches 2117760 and 2120100 due to temperature excursion that may compromise product performance and reliability.
Product
PPM INDUSTRY COMBOURG LPT BROTH (4X3L), CATALOG 410849
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0857-2023·2023-01-11
VITEK 2 AST-XN09 test kit recalled for improper storage temperature and time conditions
Biomerieux is recalling VITEK 2 AST-XN09 test kits where performance cannot be guaranteed due to storage outside proper temperature and time parameters. Affected kits nationwide should not be used.
Product
VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0865-2023·2023-01-11
Biomerieux Recalls VIDAS LH 60 Clinical Tests for Temperature-Induced Performance Issues
Biomerieux is recalling VIDAS LH 60 diagnostic test kits nationwide due to temperature and time excursion. The affected batch's product performance cannot be guaranteed due to storage conditions exceeding acceptable parameters.
Product
VIDAS CLINICAL VIDAS LH 60 TESTS, CATALOG 30406-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0906-2023·2023-01-11
DeRoyal Tonsillectomy Tray recalled for potential suction port occlusion
DeRoyal is recalling certain Tonsillectomy Tray lots due to potential blockage of suction ports in the integrated electrosurgical suction coagulator. The defect may prevent proper suction function during surgical procedures.
Product
DeRoyal Tonsillectomy Tray, REF 89-10698.01
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0797-2023·2023-01-11
Biomerieux VIDAS RUB IGG Tests Recalled Due to Storage Conditions
Biomerieux is recalling VIDAS RUB IGG diagnostic tests nationwide after storage temperature and duration exceeded specifications, affecting product performance guarantees.
Product
VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0784-2023·2023-01-11
Biomerieux API 20 E 25 Strips Recalled for Storage Condition Failure
Biomerieux Inc is recalling API 20 E 25 Strips (Batch 1009226560) because temperature and time excursions during storage exceeded specified parameters. Product performance cannot be guaranteed.
Product
API 20 E 25 STRIPS, CATALOG 20100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0904-2023·2023-01-11
Laboratory quality control material with degraded potency affecting diagnostic verification
Randox Liquid Assayed Specific Protein Control Level 2 has lost potency in rheumatoid factor, causing laboratory quality control tests to fail and delaying patient test results.
Product
Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0822-2023·2023-01-11
FDA Recalls ETEST Ertapenem Antibiotic Susceptibility Test Due to Storage Damage
Biomerieux Inc. is recalling ETEST Clinical Ertapenem antibiotic susceptibility test strips after temperature and time excursions compromised product performance. Affected units cannot guarantee accurate test results.
Product
ETEST CLINICAL ERTAPENEM ETP 32 US S30, CATALOG 412331
Category
Medical Device
Distribution
Distributed nationwide

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10876–10900 of 40095