The Recall Desk

Hazard

Storage Condition Failure recalls

18 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
18
Critical
0
Severe
0
Most recent
2025-06-04

Of the 18 storage condition failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all storage condition failure recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–18 of 18

  • HighFDA (Devices)·Z-1826-2025·2025-06-04

    Cholestech LDX Lipid Profile and Glucose Test Kits Recalled

    McKesson Medical-Surgical is recalling Cholestech LDX Lipid Profile+Glucose test kits due to transit delays and severe thunderstorms that may have exposed products to improper storage conditions, risking incorrect or delayed test results.

    Product
    ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1827-2025·2025-06-04

    HemoCue Glucose 201 Analyzer Microcuvettes Recalled for Storage Conditions

    HemoCue INC F/Glucose 201 Analyzer microcuvettes are being recalled due to transit delays caused by severe thunderstorms that may have resulted in storage outside recommended conditions, which could cause incorrect or delayed test results.

    Product
    HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1837-2025·2025-06-04

    ORTHO CLINICAL DIAGNOSTICS VITROS BUN Reagent Recall Nationwide

    ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN clinical reagent is being recalled due to transit delays caused by severe thunderstorms that may have exposed products to improper storage conditions, risking incorrect or delayed test results.

    Product
    ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1841-2025·2025-06-04

    Abbott Diagnostics Probe Conditioning Solution Recall

    Abbott Diagnostics Probe Conditioning Solution for Architect analyzers is being recalled due to cold chain failures during severe thunderstorms. Products may have been stored outside recommended conditions, risking incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1830-2025·2025-06-04

    Abbott HbA1c Hemoglobin Afinion Test Kit Cold Chain Failure

    Abbott HbA1c Hemoglobin Afinion test kits are being recalled due to transit delays caused by severe thunderstorms that may have exposed products to storage temperatures outside the manufacturer's recommended range, potentially causing incorrect or delayed test results.

    Product
    ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1847-2025·2025-06-04

    Abbott ARCHITECT HBSAG Assay Reagent Recall Due to Storage Condition Failure

    Abbott ARCHITECT HBSAG Assay reagent may have been stored outside recommended conditions due to transit delays caused by severe thunderstorms, potentially resulting in incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1851-2025·2025-06-04

    Abbott Diagnostics Architect Progesterone Reagent Storage Condition Recall

    Abbott Diagnostics Architect Progesterone (100 tests) reagent is being recalled due to transit delays during severe thunderstorms that may have caused storage outside recommended conditions, risking incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1838-2025·2025-06-04

    HemoCue Inc Hemotrol Low Control affected by cold chain transit delays

    HemoCue Inc Hemotrol Low Level 1 control product was subject to transit delays during severe thunderstorms that may have caused storage outside recommended temperature conditions, potentially leading to incorrect or delayed test results.

    Product
    HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1834-2025·2025-06-04

    Ortho Clinical Diagnostics Diluent Pack Recall Due to Cold Chain Failure

    McKesso Medical-Surgical Inc. is recalling Ortho Clinical Diagnostics FS Diluent Packs due to transit delays from severe thunderstorms that may have caused improper storage conditions. The affected products could produce incorrect or delayed test results.

    Product
    ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3.
    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-0808-2023·2023-01-11

    API VP1 VP2 Medical Reagents Recalled for Storage Condition Failure

    Biomerieux Inc is recalling API VP1 VP2 reagents (Catalog 70422) nationwide because storage temperature and time limits were exceeded, preventing the manufacturer from guaranteeing product performance.

    Product
    API VP1 VP2 REAGENTS, CATALOG 70422
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0866-2023·2023-01-11

    Biomerieux VIDAS Progesterone Tests Recalled for Storage Condition Failure

    Biomerieux is recalling VIDAS Progesterone 60 diagnostic tests (Batch 1009375960) nationwide due to storage temperature and time conditions being exceeded, preventing guaranteed product performance.

    Product
    VIDAS CLINICAL VIDAS PROGESTERONE 60 TESTS, CATALOG 30409-01
    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
  • 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-0852-2023·2023-01-11

    Medical Device Recall: ETEST Meropenem/Vaborbactam Due to Storage Temperature Excursion

    Biomerieux is recalling 6 units of ETEST Meropenem/Vaborbactam susceptibility test kits (Batch 1008848690) distributed nationwide because they were stored outside specified temperature and time ranges, preventing guarantee of product performance.

    Product
    ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560
    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