The Recall Desk

Hazard

Shelf Life Failure recalls

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

What the numbers show

Total
7
Critical
0
Severe
0
Most recent
2022-03-09

Of the 7 shelf life 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 shelf life 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.

1–7 of 7

  • HighFDA (Devices)·Z-0700-2022·2022-03-09

    Helix Elite Molecular Standard Fails FDA Shelf-Life Stability Testing

    Microbiologics Inc. recalls Helix Elite Inactivated Neisseria gonorrhoeae Strain GL0071 molecular standard after real-time shelf life testing failed at 24 months. The product was distributed nationwide and internationally.

    Product
    Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0698-2022·2022-03-09

    QC Control Panels Fail Shelf Life Stability Test at 24 Months

    Microbiologics QC control panels for bacterial diagnostic testing failed shelf life validation at 24 months. The 29 affected units were distributed across US states and internationally to Canada, UK, Australia, Belgium, and India.

    Product
    Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control Panel. Containing High, Medium and Low Level Controls.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0701-2022·2022-03-09

    Helix Elite Molecular Standards recalled due to shelf life test failure

    Microbiologics Inc is recalling Helix Elite Molecular Standards for Inactivated Influenza A/B and Respiratory Syncytial Virus because shelf life testing failed at 24 months, potentially affecting product stability.

    Product
    Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and Respiratory Syncytial Virus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0697-2022·2022-03-09

    Microbiologics QC Panel Recalled Due to Shelf Life Testing Failure

    Microbiologics Inc is recalling its Helix Elite Extended Enteric Bacterial Verification Panel because real-time shelf life testing failed at 24 months.

    Product
    Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets each comprised of the following 8 organisms: 1. S. Typhimurium derived from NCTC 74, 2. S. sonnei derived from NCTC 12984, 3. E. coli derive
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0235-2022·2021-11-24

    Syphilis Test Reagent Pack Recalled Due to False Positive Results

    Bio-Rad is recalling 11,610 units of BioPlex 2200 syphilis test reagent packs because they can produce false positive results that don't confirm with follow-up tests, due to elevated reactivity and shelf-life issues.

    Product
    BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or ti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1321-2016·2016-04-13

    ArthroCare Recalls TOPAZ MicroDebrider Devices Due to Shelf-Life Failure

    ArthroCare Corporation is recalling 26,903 TOPAZ MicroDebrider devices because they failed to meet shelf-life requirements at their expiration dates.

    Product
    TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01
    Category
    Medical Device
    Distribution
    Distributed nationwide