The Recall Desk

Hazard

Product Efficacy recalls

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

What the numbers show

Total
14
Critical
0
Severe
1
Most recent
2020-06-10

Of the 14 product efficacy recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (7%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all product efficacy 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.

1–14 of 14

  • ModerateFDA (Devices)·Z-2186-2020·2020-06-10

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

    Osteomed, LLC is recalling 153 units of Osteovationex 3cc ImpactFormula bone void filler because the labeled shelf-life may be incorrect, potentially affecting the product's setting characteristics.

    Product
    OSTEOVATIONEX 3CC IMPACTFORMULA. REF/UDI: 390-0203/00813845020030 - 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-2183-2020·2020-06-10

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

    Osteomed, LLC is recalling 417 units of Osteovation 5cc Inject Formula because the labeled shelf-life may be incorrect, potentially affecting the product's setting characteristics.

    Product
    OSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - 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-2182-2020·2020-06-10

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

    Osteomed, LLC is recalling 647 units of Osteovationex 5cc Inject Formula because the labeled shelf-life may be incorrect, potentially affecting the product's setting characteristics.

    Product
    OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - 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-2190-2020·2020-06-10

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

    Osteomed, LLC is recalling Osteovation 10 CC Impact Formula bone void filler kits because the labeled shelf-life may be incorrect, potentially affecting the product's setting characteristics.

    Product
    OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - 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-2172-2018·2018-06-20

    BioMérieux Recalls Oxidase Reagent Due to Temperature Excursion in Guadeloupe

    BioMérieux is recalling Oxidase Reagent (ref: 55635) in Guadeloupe after a shipment experienced temperature excursions up to 47.8°C, exceeding acceptable limits.

    Product
    Oxidase Reagent (ref: 55635): This test is used to detect the production of the enzyme cytochrome oxidase by bacteria. This enzyme is characteristic of the genus Neisseria and most species of Pseudomonas. It enables the differentiation of Gram (-) bacilli (1, 2). A microorgan
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2165-2018·2018-06-20

    BioMérieux Recalls VITEK 2 NH Cards Due to Temperature Excursion

    BioMérieux is recalling VITEK 2 Neisseria-Haemophilus identification cards in Guadeloupe that were exposed to temperatures exceeding acceptable limits.

    Product
    The VITEK 2 Neisseria-Haemophilus identification card (NH) is intended for use with the VITEK 2 Systems for the automated identification of most clinically significant fastidious organisms. The VITEK 2 NH identification card is a single-use disposable. A microorganism differe
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2168-2018·2018-06-20

    BioMérieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Temperature Excursion

    BioMérieux is recalling VITEK 2 Gram Negative Susceptibility Cards shipped to Guadeloupe that experienced a temperature excursion exceeding acceptable limits.

    Product
    The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic gram negative bacilli to antimicrobial agents. Fully automated short-term
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2171-2018·2018-06-20

    BioMérieux Recalls Color Gram 2 Stains Due to Temperature Excursion

    BioMérieux is recalling Color Gram 2 stains in Guadeloupe after a shipment experienced a temperature excursion exceeding acceptable limits.

    Product
    Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and fungal microorganisms for direct examination, according to the Gram method. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in sol
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0118-2018·2017-12-27

    Advanced Pharma Recalls NitroGlycerin Syringes Due to Stability Data Issues

    Advanced Pharma Inc. is recalling 680 syringes of NitroGlycerin injection because stability data does not support the product's expiry dates.

    Product
    NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FORTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-67.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3120-2017·2017-09-20

    Leica Biosystems Recalls Podoplanin Antibody Due to Temperature Excursion

    Leica Biosystems Richmond Inc. is recalling four units of Podoplanin (D2-40 Mab) antibody because a delay in transit may have caused the product to be stored outside of required temperature limits.

    Product
    Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Podoplanin (D2-40) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3123-2017·2017-09-20

    Leica Biosystems Recalls MSH6 Antibody Due to Temperature Deviation

    Leica Biosystems Richmond Inc. is recalling 13 units of MSH6 antibody (REF PA0804) because a delay in transit may have caused the product to be stored outside of required temperature ranges.

    Product
    Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended for in vitro diagnostic (IVD) use. MSH6 is a mismatch repair gene which is deficient in a high proportion of patients with microsatellite instability (MSI-H). This finding is associated with the autoso
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1311-2014·2014-05-14

    Merck Recalls Liptruzet Tablets Due to Packaging Defects

    Merck is recalling Liptruzet tablets because outer packaging defects allowed air and moisture to enter, potentially affecting product effectiveness.

    Product
    Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg, a) 30 count blister (NDC 66582-322-30), b) 90 count blister (NDC 66582-322-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1065-2013·2013-10-09

    AmeriSource Bergen Recalls Ifosfamide Injection Due to Temperature Abuse

    AmeriSource Bergen is recalling 49 vials of Ifosfamide Injection 1g/20mL because they were not properly refrigerated at distribution centers.

    Product
    Ifosfamide Injection 1g/20mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4495-22
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2196-2013·2013-09-25

    Assuramed Recalls DiaScreen Liquid Urine Controls Due to Storage Temperature Issues

    Assuramed is recalling DiaScreen Liquid Urine Controls because they may have been stored at temperatures outside required conditions.

    Product
    DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine Urinalysis; Product Number D76004 (4x12 mL bottles) consists of: 2x12mL Positive controls [and] 2x12mL Negative controls; Manufactured for ARKRAY USA, Inc.; Mi
    Category
    Medical Device
    Distribution
    Distributed nationwide