The Recall Desk

Hazard

Sterility Failure recalls

1,691 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,691
Critical
12
Severe
931
Most recent
2026-07-29

Of the 1,691 sterility failure recalls we have scored against our rubric, 12 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 931 (55%) 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 sterility 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.

526–550 of 1691

  • SevereFDA (Drugs)·D-0133-2021·2020-12-23

    Thymosin Alpha Vials Recalled for Sterility Assurance Concerns

    Advanced Nutriceuticals, LLC is recalling Thymosin Alpha vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    THYMOSIN ALPHA, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0132-2021·2020-12-23

    FDA Recalls BPC-157 Vials Due to Sterility Concerns

    Advanced Nutriceuticals, LLC is recalling BPC-157 vials because production processes cannot assure the sterility of the product.

    Product
    BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0134-2021·2020-12-23

    Advanced Nutriceuticals Recalls IPAMORELIN Vials Due to Sterility Concerns

    Advanced Nutriceuticals is recalling IPAMORELIN vials because production processes cannot assure the sterility of the product.

    Product
    IPAMORELIN, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0129-2021·2020-12-23

    Advanced Nutriceuticals Recalls FGL Vials Due to Sterility Concerns

    Advanced Nutriceuticals is recalling FGL 10 mg/ml vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    FGL, 10 MG/ML, 3 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0135-2021·2020-12-23

    Advanced Nutriceuticals Recalls GHRP Vials Due to Sterility Concerns

    Advanced Nutriceuticals is recalling GHRP vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    GHRP, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0136-2021·2020-12-23

    FDA Recalls NANDROLONE Injections Due to Sterility Concerns

    Advanced Nutriceuticals, LLC is recalling NANDROLONE 200 mcg/mL injections because production processes cannot assure sterility. The recall affects vials distributed to seven states.

    Product
    NANDROLONE, 200 MCG/ML, 2 ML, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0130-2021·2020-12-23

    PT-141 Injection Recalled Due to Sterility Assurance Concerns

    Advanced Nutriceuticals is recalling PT-141 vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    PT-141, 10 MG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0142-2021·2020-12-23

    High Dose B12 Injection Recalled for Sterility Assurance Concerns

    Advanced Nutriceuticals is recalling High Dose B12 vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    HIGH DOSE B12, 10 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0143-2021·2020-12-23

    Advanced Nutriceuticals Recalls LL-37 Vials Due to Sterility Concerns

    Advanced Nutriceuticals is recalling LL-37 vials because production processes cannot assure sterility. The product was distributed to seven states.

    Product
    LL-37, 2000 MCG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • HighFDA (Devices)·Z-3018-2020·2020-10-07

    North American Rescue Recalls Emergency Trauma Dressings Due to Sterility Concerns

    North American Rescue LLC is recalling 4 In. Flat Responder Emergency Trauma Dressings because they may lack sterility assurance. The affected dressings are packaged in various first aid and trauma kits.

    Product
    4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged in kits labeled as follows: a) M-FAK Mini First Aid Kit; Kit Product Code: 80-0890 b) M-FAK Mini First Aid Kit, with Bleeding Control Dressing; Kit Product Code: 80-0891 c) M-FAK Mini First Aid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2989-2020·2020-09-30

    Wright Medical Recalls Evolve Stem Implants Due to Sterility Assurance Issues

    Wright Medical Technology is recalling 16 Evolve Stem 8.5mm implants because they lack sterility assurance. The recall covers units distributed in the US and several international countries.

    Product
    EVOLVE STEM 8.5MM Model # 496S085
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-2487-2020·2020-07-15

    Prodimed Combicath Catheters Recalled for Sterility Assurance Concerns

    Prodimed Plastimed Division is recalling 7,220 Combicath catheters for mini bronchoalveolar lavage due to a lack of assurance of sterility.

    Product
    Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 60 cm x 2.7 mm Product Code: 58216 27US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2490-2020·2020-07-15

    Prodimed Combicath catheters recalled due to sterility assurance concerns

    Prodimed is recalling 1,460 Combicath catheters nationwide because the company cannot assure the products are sterile.

    Product
    Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH PE 90 cm Product Code: 58229 19
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1750-2020·2020-04-29

    Biomet Shoulder Surgery Pliers Recalled for Sterility Concerns

    Biomet is recalling 125 units of Comprehensive Humeral Tray Taper Extraction Pliers replacement tips due to unknown bioburden levels that may affect sterility.

    Product
    Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surgery to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1095-2020·2020-04-15

    Innovative Compounding Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns

    Innovative Compounding Pharmacy is recalling specific lots of Methylcobalamin Injectable due to a lack of assurance of sterility. Patients in California, Maine, and Texas should stop using the product.

    Product
    Methylcobalamin Soln. 1000 mcg/ml, 10 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1090-2020·2020-04-15

    PharMEDium Recalls 46 Lots of IV Products Due to Sterility Concerns

    PharMEDium Services, LLC is recalling 46 lots of various IV products because of a lack of sterility assurance. The products were distributed nationwide in the US.

    Product
    ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe, For IV Use, Rx Only, PharMEDium 913 N. Davis Ave. Cleveland, MS 98732 NDC 71030-003-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1642-2020·2020-04-15

    Biomet Recalls StageOne Hip Cement Spacer Molds Due to Cleaning Concerns

    Biomet is recalling StageOne Hip Cement Spacer Molds because the cleaning process may have been insufficient or inadequately monitored.

    Product
    BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Drugs)·D-1073-2020·2020-04-08

    Medical Center Pharmacy Recalls C-Albumin Eye Drops Due to Sterility Concerns

    Medical Center Pharmacy is recalling specific lots of C-Albumin Eye Drop 10% S because production processes cannot assure sterility. Patients in Tennessee who received these prescriptions should contact their healthcare provider.

    Product
    C-*Albumin Eye Drop 10% S, packaged in 10 mL bottles, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 44206-0251-05.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1530-2020·2020-04-01

    Karl Storz Flexible Pediatric Neuroscopes Recalled Due to Sterilization Manual Error

    Karl Storz Endoscopy is recalling 73 flexible pediatric neuroscopes because the instruction manual contains incorrect sterilization information for the STERIS System 1E, which may compromise sterility.

    Product
    Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1523-2020·2020-03-25

    Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns

    Avid Medical is recalling 5,004 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.

    Product
    Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1521-2020·2020-03-25

    Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns

    Avid Medical, Inc. is recalling 628 custom procedure trays because they contain surgical gowns that may not be sterile. This poses a risk of surgical site infection and cross-contamination.

    Product
    Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1517-2020·2020-03-25

    Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns

    Avid Medical, Inc. is recalling 1,644 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.

    Product
    Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1516-2020·2020-03-25

    Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns

    Avid Medical, Inc. is recalling 1,906 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.

    Product
    Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
    Category
    Medical Device
    Distribution
    13 states