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 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.

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20001–20025 of 27461

  • HighFDA (Devices)·Z-0869-2023·2023-01-11

    Medical Device Reagent Recall Due to Storage Condition Exceedance

    Biomerieux is recalling DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 reagent kits because temperature and time storage conditions were exceeded, preventing performance guarantees. Distributed nationwide, affected units should be removed from service.

    Product
    DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0860-2023·2023-01-11

    ETEST Vancomycin Susceptibility Test Recalled Due to Storage Damage

    Biomerieux recalled ETEST vancomycin susceptibility tests after storage temperature and time excursions that may compromise product reliability and test accuracy.

    Product
    ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788
    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-0776-2023·2023-01-11

    Guardian Glucose Monitoring App May Automatically Log Out and Block Data Upload

    The Guardian continuous glucose-monitoring app may automatically log out, preventing data uploads and SMS alerts to care partners. This could result in missed detection of dangerous blood sugar levels.

    Product
    Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0843-2023·2023-01-11

    FDA Recalls VITEK 2 AST-GP75 Test Kits for Storage Condition Violations

    Biomerieux Inc recalled 218 units of VITEK 2 AST-GP75 diagnostic test kits due to storage temperature and time violations that compromise test reliability. Affected facilities should stop using the recalled kits.

    Product
    VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0859-2023·2023-01-11

    ETEST Meropenem antibiotic susceptibility test recalled due to storage excursion

    Biomerieux is recalling ETEST Meropenem diagnostic tests because units experienced temperature and time storage excursions that may affect test accuracy. Affected lot 1009462290 was distributed nationwide.

    Product
    ETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0801-2023·2023-01-11

    Medical device diagnostic plates recalled for storage condition violations

    Biomerieux Inc is recalling PPM Clinical Chromid Candida diagnostic plates because storage temperature and time parameters were exceeded, preventing performance guarantees.

    Product
    PPM CLINICAL CRAPONNE CLINICAL CHROMID CANDIDA 20 PLATES, CATALOG 43631
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0847-2023·2023-01-11

    Medical Laboratory Diagnostic Media Recalled Due to Storage Condition Violations

    Biomerieux Inc. is recalling PPM CLINICAL CHROMID STREPTO B diagnostic media (batch 1009534170) because storage temperature and time exceeded specified limits, preventing assurance of product performance.

    Product
    PPM CLINICAL CHROMID STREPTO B US 20 PLT, CATALOG 419751
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0871-2023·2023-01-11

    Medical Diagnostic Device Recalled Due to Temperature and Time Excursions

    Biomerieux Inc. is recalling PPM LOMBARD diagnostic products due to storage temperature and time conditions being exceeded during distribution, which compromises the product's guaranteed performance.

    Product
    PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT, CATALOG C6045-IR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0799-2023·2023-01-11

    VIDAS Salmonella Diagnostic Test Kits Recalled Due to Storage Damage

    Biomerieux Inc. is recalling 15 units of VIDAS VIDAS Salmonella 60T diagnostic test kits (Catalog 30702) because storage conditions exceeded acceptable temperature and time parameters. The affected test kits may not perform reliably.

    Product
    VIDAS CLINICAL VIDAS SALMONELLA 60T, CATALOG 30702
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0876-2023·2023-01-11

    PPM Lombard Phosphate Buffer Recall Due to Temperature Exposure

    Biomerieux Inc is recalling PPM Lombard Phosphate Buffer products due to temperature and time exposure during storage or transport that may have compromised product performance.

    Product
    PPM LOMBARD PRODUCTS T PHOSPHATE BUFFERSTERILE 20X9ML, CATALOG T8035
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0795-2023·2023-01-11

    VIDAS Varicel Zoster IGG 60T Recalled Due to Storage Condition Excursion

    Biomerieux Inc is recalling VIDAS Varicel Zoster IGG 60T (Catalog 30217, Batch 229478) due to storage temperature and time exceedance. The recalled units cannot be guaranteed to perform accurately.

    Product
    VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0819-2023·2023-01-11

    ETEST Clinical Amoxicillin/Clavulanic Acid Test System Recalled Due to Storage Excursion

    Biomerieux Inc is recalling ETEST CLINICAL AMOXI/CLAV 2/1 XL test systems nationwide (batch 1009311920) due to temperature and time storage excursions that may affect product performance.

    Product
    ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412252
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0130-2023·2023-01-11

    Epi-Caine Intraocular Injection Recalled Due to Raw Material Discoloration

    Pine Pharmaceuticals is recalling Epi-Caine intraocular injection (11,453 vials nationwide) due to discoloration in raw material used for compounding, a manufacturing quality control failure.

    Product
    Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection, 1 ml, Single Dose Vial, Compounded by Pine Pharmaceuticals, 355 Riverwalk Pkwy, Tonawanda, NY 14150. NDC 69194-0948-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalCPSC·23089·2023-01-09

    Kids2 Rocking Sleepers Recalled After 15 Infant Deaths

    Kids2 is recalling approximately 694,000 Rocking Sleepers after 15 infant fatalities were reported. Infants died after rolling from their back to their stomach or side while unrestrained.

    Product
    All models of Kids2 Rocking Sleepers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalCPSC·23088·2023-01-09

    Fisher-Price Recalls 4.7 Million Rock 'n Play Sleepers Due to Infant Deaths

    Fisher-Price is recalling approximately 4.7 million Rock 'n Play Sleepers after at least 8 deaths were reported following the initial April 2019 recall announcement. Infants have died after rolling from their back to their stomach or side while unrestrained.

    Product
    All models of Rock 'n Play Sleepers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·23720·2023-01-05

    Polaris Sportsman and Scrambler 1000 S ATVs recalled for fire hazard

    Polaris is recalling certain 2020–2023 Sportsman and Scrambler 1000 S all-terrain vehicles because electrostatic discharge can ignite fuel during refueling, creating a fire hazard. The company has received 16 reports of fires, including one personal injury.

    Product
    Model Year 2020-2023 Sportsman 1000 S and Scrambler 1000 S All-Terrain Vehicles (ATVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23085·2023-01-05

    P.J. Salvage Children's Pajamas Recalled for Flammability Hazard

    P.J. Salvage is recalling about 2,650 children's pajama sets that fail to meet federal flammability standards for sleepwear, posing a risk of burn injuries to children.

    Product
    Children's pajamas
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23086·2023-01-05

    Quality Bicycle Products Carbon Handlebars and Bicycles Injury Hazard

    Quality Bicycle Products is recalling carbon handlebars and bicycles because the handlebars can crack where brake and shift levers are installed, posing a crash and injury risk. The company has received 37 reports of cracking but no injuries have been reported.

    Product
    Bicycle handlebars and bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0208-2023·2023-01-04

    Favorina Advent Calendar recalled for potential Salmonella contamination

    Lidl US Trading is recalling Favorina Advent Calendar due to potential Salmonella contamination. Approximately 10,524 units were distributed throughout the United States.

    Product
    Favorina Advent Calendar NET WT. 8.4OZ (240g) Premium Chocolate with a Creamy Filling UPC 4056489516965
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0212-2023·2023-01-04

    Lukai sweetened jujube products recalled for undeclared sulfites

    Lukai sweetened jujube products are recalled because they contain undeclared sulfites at 17.9 mg per serving. This allergen poses a risk to consumers with sulfite sensitivity.

    Product
    "Lukai sweetened jujube"; 8.3 ounces; red and yellow packaging; back panel states: "Name: Ejiao dates; Ingredients: a nuclear-free golden jujube, donkey-hide gelatin, sugar, honey, maltose, citric acid; Consumption methods: open bags of ready-to-eat, soup, making cakes; Shelf li
    Category
    Food
    Distribution
    13 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
  • 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 Dual-Tra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0211-2023·2023-01-04

    Phil's Power Pancakes recalled due to undeclared wheat allergen

    Phil's Power Pancakes are being recalled because they contain wheat that is not listed on the label. Consumers with wheat allergies who have purchased this product should not consume it.

    Product
    Phil's Power Pancakes 5 oz. individually wrapped units 5 varieties, including (Chocolate Hempseed, Cranberry, Raspberry, Mango, and Date) UPC: 8 3765448372 5
    Category
    Food
    Distribution
    0 states