The Recall Desk

Hazard

Product Performance recalls

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

What the numbers show

Total
12
Critical
0
Severe
0
Most recent
2023-01-11

Of the 12 product performance 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 product performance 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.

1–12 of 12

  • HighFDA (Devices)·Z-0833-2023·2023-01-11

    FDA Recalls VITEK 2 Antibiotic Susceptibility Test Kits Due to Storage Excursion

    Biomerieux Inc. is recalling VITEK 2 REAGENT AST-GN69 test kits nationwide due to temperature and time excursions during storage that may compromise product performance.

    Product
    VITEK 2 REAGENT AST-GN69 TEST KIT 20 CARDS, CATALOG 413400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0849-2023·2023-01-11

    Microbiological susceptibility test strips recalled for temperature and time excursion

    Biomerieux Inc. is recalling ETEST Clinical Imipenem Relebactam test strips (Catalog 420927) distributed nationwide because the product experienced temperature and time excursions during storage. The manufacturer cannot guarantee the product's test performance.

    Product
    ETEST CLINICAL IMIPENEM RELEBACTAM IPR US S30, CATALOG 420927
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0786-2023·2023-01-11

    Diagnostic Test Kit Recalled Due to Exceeded Storage Conditions

    Biomerieux Inc is recalling API STAPH 25 diagnostic test kits because storage conditions exceeded safe temperature and time parameters. Product performance cannot be guaranteed for the affected batch.

    Product
    API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500
    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-2181-2020·2020-06-10

    Osteomed Recalls Osteovationex Bone Void Filler Due to Shelf-Life Error

    Osteomed, LLC is recalling Osteovationex 3cc Inject Formula bone void fillers because the product may not maintain its setting characteristics for the labeled shelf-life duration.

    Product
    OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2180-2020·2020-06-10

    Osteomed Recalls Osteovationex Bone Void Filler Due to Shelf-Life Error

    Osteomed, LLC is recalling 70 units of Osteovationex 2cc Inject Formula because the product may not maintain its setting characteristics for the labeled shelf-life duration.

    Product
    OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2184-2020·2020-06-10

    Osteomed Recalls Osteovation Bone Void Filler Due to Shelf-Life Error

    Osteomed is recalling 436 units of Osteovation 10cc Inject Formula because the labeled shelf-life may be incorrect, potentially affecting the product's setting characteristics.

    Product
    OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2187-2020·2020-06-10

    Osteomed Recalls Osteovation 3CC ImpactFormula Bone Void Filler Kits

    Osteomed is recalling 409 units of Osteovation 3CC ImpactFormula bone void filler kits due to incorrect shelf-life labeling that may affect product setting characteristics.

    Product
    OSTEOVATION 3CC IMPACTFORMULA. REF/UDI: 390-2103/00813845020078 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1227-2017·2017-03-01

    Siemens N Latex HCY Reagent Recalled for Stability Issues

    Siemens Healthcare Diagnostics is recalling N Latex HCY Reagent kits due to reduced stability that may cause inaccurate homocysteine test results.

    Product
    N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry with BN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1687-2016·2016-05-25

    Diamedix IgG Test Kits Recalled Due to Gel-Like Substance in Diluent

    Diamedix Corporation is recalling 94 Is-EBV-EA-D and Is-Mumps IgG Test Kits because a gel-like substance was found in the sample diluent, potentially compromising performance.

    Product
    Diamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0559-2013·2012-12-26

    Integra Recalls Mayfield Skull Clamps Due to Performance Issues

    Integra LifeSciences is recalling eight Mayfield Composite Series Skull Clamps (Model A3059) due to product performance issues that could impact functionality.

    Product
    MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0558-2013·2012-12-26

    Integra LifeSciences Recalls Mayfield Composite Series Base Units

    Integra LifeSciences is recalling Mayfield Composite Series Base Units and Skull Clamps due to performance issues that could impact functionality.

    Product
    MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) is an integral component of the Base Unit, Model A3101. The MAYFIELD Base Unit (A3101) is an operating room table accessory intended to be used to support a patient during diagnostic examination and/or
    Category
    Medical Device
    Distribution
    Distributed nationwide