The Recall Desk

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.

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10901–10925 of 39932

  • ModerateFDA (Devices)·Z-0816-2023·2023-01-11

    Clinical Reagent Vitek MS-FA Recalled Due to Storage Condition Violations

    Biomerieux is recalling VITEK MS-FA clinical reagent due to storage condition violations that degrade product performance. The recall affects 29 units distributed nationwide.

    Product
    VITEK MS CLINICAL REAGENT VITEK MS-FA, CATALOG 411072
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0839-2023·2023-01-11

    Biomerieux CHROMID CARBA Laboratory Product Recalled Due to Storage Condition Violations

    Biomerieux Inc is recalling CHROMID CARBA laboratory products nationwide because storage conditions exceeded acceptable temperature and time ranges. The company cannot guarantee product performance.

    Product
    PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT, CATALOG 414012
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0821-2023·2023-01-11

    ETEST Ceftriaxone Antibiotic Test Strips Recalled for Storage Condition

    Biomerieux is recalling ETEST Clinical Ceftriaxone test strips nationwide because storage temperature and time conditions were exceeded, which may affect product analytical performance.

    Product
    ETEST CLINICAL CEFTRIAXONE TX 32 US S30, CATALOG 412302
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0791-2023·2023-01-11

    VITEK 2 Reagent Test Kit Recalled Due to Storage Temperature and Time Exceedance

    Biomerieux Inc is recalling VITEK 2 Reagent NH Test Kit units nationwide because they were stored outside proper temperature and time parameters. Product performance cannot be guaranteed.

    Product
    VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0826-2023·2023-01-11

    Levofloxacin ETEST Clinical Test Recalled for Improper Storage Conditions

    Biomerieux Inc. is recalling 7 units of ETEST CLINICAL LEVOFLOXACIN LE 32 US S30 diagnostic test kits (Batch 1009240000) due to temperature and time storage condition violations that prevent guarantee of product performance.

    Product
    ETEST CLINICAL LEVOFLOXACIN LE 32 US S30, CATALOG 412392
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0806-2023·2023-01-11

    Biomerieux BIOBALL B.SPIZIZENII culture products recalled for storage failure

    Biomerieux is recalling BIOBALL B.SPIZIZENII NCTC 10400 (Catalog 56012) microbiological test cultures because storage temperature and time conditions were exceeded, and product performance cannot be guaranteed.

    Product
    BIOBALL B.SPIZIZENII NCTC 10400 550X20, CATALOG 56012
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0836-2023·2023-01-11

    FDA Recalls VITEK 2 AST-GN79 Reagent Test Kit for Temperature Excursion

    Biomerieux Inc. is recalling 310 units of the VITEK 2 REAGENT AST-GN79 TEST KIT (batches 5992201403 and 5992253503) nationwide because temperature and time conditions exceeded specified ranges, preventing guaranteed product performance.

    Product
    VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS, CATALOG 413436
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0845-2023·2023-01-11

    Laboratory Testing Product Recall Due to Temperature Storage Excursion

    Biomerieux Inc is recalling PPM Lombard Products TSA 3P W Neutralizers due to storage temperature and time excursions that degrade product performance. Affected units cannot guarantee reliable testing results.

    Product
    PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 419014
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0867-2023·2023-01-11

    Biomerieux VIDAS Estradiol II Test Systems Recalled for Storage Condition Exceedance

    Biomerieux Inc is recalling VIDAS Estradiol II 60 Tests (Catalog 30431-01, Batch 1009378680) distributed nationwide after temperature and time storage conditions were exceeded, potentially compromising test reliability.

    Product
    VIDAS CLINICAL VIDAS ESTRADIOL II 60 TESTS, CATALOG 30431-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0807-2023·2023-01-11

    Biomerieux BIOBALL P.AERUGINOSA Quality Control Product Recalled for Temperature Excursion

    Biomerieux Inc is recalling the BIOBALL P.AERUGINOSA NCTC 12924 quality control product due to temperature and time excursions that may affect product performance. Two units with batch number 7240 were distributed nationwide.

    Product
    BIOBALL P.AERUGINOSA NCTC 12924 550X20, CATALOG 56017
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0804-2023·2023-01-11

    C. difficile diagnostic kit recalled due to storage temperature deviation

    Biomerieux is recalling a C. difficile diagnostic test kit after units were stored outside temperature and time limits, potentially compromising test performance.

    Product
    PPM CLINICAL CRAPONNE CHROMID C.DIFFICILE 20 PLT, CATALOG 43871
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0805-2023·2023-01-11

    Bioball Fungal Reference Standard Recalled for Temperature Storage Issues

    Biomerieux Inc. recalled 2 units of BIOBALL A.BRASILIENSIS NCPF 2275 reference standard (Batch 7112) after temperature and time storage conditions exceeded acceptable ranges. The manufacturer cannot guarantee product performance.

    Product
    BIOBALL A.BRASILIENSIS NCPF 2275 550X20, CATALOG 56011
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0850-2023·2023-01-11

    Biomerieux Recalls VITEK 2 Diagnostic Test Kit Due to Storage Conditions

    Biomerieux Inc has recalled the VITEK 2 Reagent AST-GP78 Test Kit nationwide due to temperature and time storage exceedances that may affect product performance. No illnesses or injuries have been reported.

    Product
    VITEK 2 REAGENT AST-GP78 TEST KIT 20 CARDS, CATALOG 421051
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0809-2023·2023-01-11

    API NIT1 NIT2 Reagents Recalled Due to Improper Storage Conditions

    Biomerieux is recalling API NIT1 NIT2 Reagents (Catalog 70442, Batch 1009326520) distributed nationwide due to storage conditions that exceeded temperature and time parameters, preventing guaranteed product performance.

    Product
    API NIT1 NIT2 REAGENTS, CATALOG 70442
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0825-2023·2023-01-11

    ETEST Clinical Imipenem Susceptibility Test Kits Recalled Due to Storage Deviation

    Biomerieux Inc. is recalling ETEST Clinical Imipenem IP 32 susceptibility test kits nationwide because temperature and time storage conditions were exceeded, which may affect product performance.

    Product
    ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0903-2023·2023-01-11

    Quality Control Material Potency Decline Causes Out-of-Range Laboratory Results

    Randox Laboratories recalls a quality control product (PS2682) because Rheumatoid Factor concentration has declined, causing out-of-range quality control results and delayed laboratory test reporting.

    Product
    Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0820-2023·2023-01-11

    FDA Recalls ETEST Clinical Benzylpenicil Test Due to Storage Excursion

    Biomerieux Inc recalls ETEST Clinical Benzylpenicil susceptibility test kits due to temperature and time excursions during storage that affect product performance. Batch 1009477980 was distributed nationwide.

    Product
    ETEST CLINICAL BENZYLPENICIL PG 256 US S30, CATALOG 412262
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0874-2023·2023-01-11

    PPM Lombard R2A Laboratory Medium Recalled for Exceeded Storage Conditions

    Biomerieux Inc is recalling PPM Lombard R2A medium products (lot 1009527290) because storage conditions exceeded acceptable parameters, compromising product performance. Approximately 20 units distributed nationwide in the United States.

    Product
    PPM LOMBARD PRODUCTS R2A MEDIUM 10PLT, CATALOG M1065
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0832-2023·2023-01-11

    Biomerieux Recalls BIOBALL K.RHIZOPHILA Diagnostic Kits Due to Storage Failure

    Biomerieux Inc recalls BIOBALL K.RHIZOPHILA diagnostic kits (batch 7408) due to exceeded temperature and time storage conditions that may compromise product performance.

    Product
    BIOBALL K.RHIZOPHILA (30X20), CATALOG 412690
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0854-2023·2023-01-11

    Biomerieux VITEK 2 AST-GN99 Diagnostic Test Kit Recalled for Storage Stability

    Biomerieux Inc is recalling 187 units of VITEK 2 REAGENT AST-GN99 TEST KIT due to storage temperature and time exceedances that may compromise test performance.

    Product
    VITEK 2 REAGENT AST-GN99 TEST KIT 20 CARDS, CATALOG 423102
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0769-2023·2023-01-04

    Orthopedic Compression Screws Distributed Without FDA Pre-Market Clearance

    Acumed LLC recalled AcuTwist Acutrak Compression Screws (80,805 units) distributed without FDA pre-market clearance. The devices lack FDA evaluation for safety and effectiveness.

    Product
    AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0770-2023·2023-01-04

    Dual-Trak Clavicle Screws recalled: distributed without FDA pre-market clearance

    Acumed LLC is recalling 7,498 units of Dual-Trak Clavicle Screws distributed worldwide without FDA pre-market clearance. These orthopedic surgical screws were marketed without required regulatory approval.

    Product
    Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 40-0137-S 3.0mm x 90mm Dual-Trak Clavicle Screw 40-0138 3.0mm x 100mm…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0771-2023·2023-01-04

    Remington Medical Automatic Cutting Needle Stylet Longer Than Specified

    Remington Medical is recalling 290 Automatic Cutting Needles with lot number 2224920 because the stylet is longer than specified on the label. Affected units were distributed in NC, WV, CA, PA, AL, and TX.

    Product
    Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0772-2023·2023-01-04

    Pilling Wecksorb Cylindrical Sponges recalled due to compromised sterility

    TELEFLEX LLC recalled 1,000 units of Pilling Wecksorb Cylindrical Sponges (Lot 22B0395) because certain lots were not irradiated to eliminate pyronema, potentially compromising sterility. No illnesses have been reported.

    Product
    Pilling Wecksorb Cylindrical Sponges
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0768-2023·2023-01-04

    Acumed Acutrak 2 Bone Screws Recalled for Distribution Without FDA Clearance

    Acumed is recalling Acutrak 2 bone screw products distributed without FDA pre-market clearance. Healthcare providers should contact Acumed or the FDA for guidance regarding use and management of these devices.

    Product
    Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 30-0025 35.0mm Acutrak 2¿ - 5.5 Screw 30-0025-S 35.0mm Acutrak 2¿ - 5.5…
    Category
    Medical Device
    Distribution
    Distributed nationwide