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.

1376–1400 of 1691

  • HighFDA (Devices)·Z-2658-2014·2014-09-24

    ZOLL Pro-padz Sterile Adult Electrodes Recalled for Sterility Concerns

    Bio-Detek is recalling 198 cases of ZOLL Pro-padz Sterile Adult Multi-Function Electrodes because the sterility of the devices is not assured.

    Product
    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per International/ Nat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1564-2014·2014-09-03

    Abrams Royal Pharmacy Recalls All Unexpired Sterile Drug Products

    Abrams Royal Pharmacy is recalling all unexpired sterile drug products due to a lack of assurance of sterility. The products were distributed nationwide and to Canada.

    Product
    All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc., Dallas, TX
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1554-2014·2014-08-27

    Healix Recalls Fentanyl Syringes Due to Sterility Concerns

    Healix Infusion Therapy is recalling 220 fentanyl prefilled syringes because the supplier recalled the drug due to loose or missing vial crimps, raising sterility concerns.

    Product
    fentaNYL 2750 mcg/55 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG, For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1514-2014·2014-08-13

    Janssen Recalls Risperdal CONSTA Due to Sterility Failure

    Janssen Pharmaceuticals is recalling one lot of Risperdal CONSTA (risperidone) 25 mg dose packs due to a sterility failure detected in a stability sample.

    Product
    RISPERDAL CONSTA — RISPERDAL CONSTA (RISPERIDONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1471-2014·2014-07-30

    Trinity Care Solutions Recalls Tobramycin Syringes Due to Sterility Concerns

    Trinity Care Solutions is recalling 14 units of Tobramycin 300 mg/7.5 mL syringes in Florida due to quality control concerns regarding sterility assurance.

    Product
    Tobramycin 300 mg/7.5 mL Syringe (for Neb), Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28503, Discard After 02/27/14
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1983-2014·2014-07-09

    Anspach Pneumatic and Electric Motor Systems Recalled for Sterility Assurance Failures

    The Anspach Effort, Inc. is recalling 115,988 pneumatic and electric motor systems because certain attachments failed to meet sterility assurance levels during sterilization.

    Product
    Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium.
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Drugs)·D-1401-2014·2014-06-25

    John W Hollis Inc Recalls Compounded Injectable Drug Due to Sterility Concerns

    John W Hollis Inc is recalling a compounded injectable drug product due to a lack of assurance of sterility. The product is distributed nationwide.

    Product
    Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 20 mcg, 10 mL, JOHN HOLLIS Pharmacist, Inc 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1394-2014·2014-06-25

    John W Hollis Recalls Mannitol 5% Solution for Injection Due to Sterility Concerns

    John W Hollis Inc. is recalling specific lots of Mannitol 5% Solution for injection because the products lack assurance of sterility.

    Product
    Mannitol 5% Solution for injection, Mannitol 50 mg, also contains Sterile Water for Injection, Chlorobutanol USP, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1402-2014·2014-06-25

    John W Hollis Inc Recalls Compounded Injectable Products Due to Sterility Concerns

    John W Hollis Inc is recalling compounded injectable products containing papaverine, phentolamine, and alprostadil due to a lack of assurance of sterility.

    Product
    Papaverine HCl 30 mg, Phentolamine Mesylate 0.5 mg, Alprostadil 10 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1392-2014·2014-06-25

    John W Hollis Inc Recalls Testosterone Cypionate Injection Due to Sterility Concerns

    John W Hollis Inc is recalling specific lots of Testosterone Cypionate for Injection because the products lack assurance of sterility.

    Product
    Testosterone Cypionate for Injection, each mL contains Testosterone Cypionate 200 mg, also contains: Cotton Seed Oil, Benzyl Benzoate, Benzyl Alcohol, Rx Only, 10 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1400-2014·2014-06-25

    John W Hollis Inc Recalls Compounded Injectable Drugs Due to Sterility Concerns

    John W Hollis Inc is recalling compounded Papaverine HCl and Phentolamine Mesylate injectable products due to a lack of assurance of sterility.

    Product
    Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1398-2014·2014-06-25

    John W Hollis Inc Recalls B-Complex/Adenosine Injectable Solution for Sterility Concerns

    John W Hollis Inc is recalling B-Complex/Adenosine Injectable Solution due to a lack of sterility assurance in the compounded aseptically filled products.

    Product
    B-Complex/Adenosine Inj sol, Adenosine-5-Monophosphate 0.03g, Choline Chloride 0.01g, Cyanocobalamin 0.3mg, Inositol 0.05g, Methionine 0.015g, Levocarnitine 0.1g, Chromic Chloride 0.15g, Lidocaine HCl 0.01g, Pyrodoxine HCl 0.005g, 30 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Aven
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1388-2014·2014-06-25

    John W Hollis Recalls Polidocanol Injection Due to Sterility Concerns

    John W Hollis Inc is recalling Polidocanol 0.5% Solution for Injection because the products lack assurance of sterility.

    Product
    Polidocanol 0.5% Solution for Injection, Polidocanol (Laureth 9) 5mg, 50 mL, JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1506-2014·2014-04-30

    Teleflex Recalls Sengstaken Tubes Due to Sterility Concerns

    Teleflex Medical is recalling Sengstaken and Sengstaken-Blakemore tubes because the sterility of the product cannot be guaranteed.

    Product
    Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800, 204802, and 204803, a gastrointestinal tube and accessories, consisting of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1167-2014·2014-03-19

    Biomet 3i Recalls Navigator Surgical Kits Due to Sterility Assurance Failure

    Biomet 3i, LLC is recalling 21 units of the Navigator Surgical Kit because the trays failed to meet required sterility assurance levels during validation testing.

    Product
    Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1171-2014·2014-03-19

    Biomet 3i Recalls Dental Torque Driver Kits Due to Sterility Failure

    Biomet 3i is recalling 181 dental torque driver kits because they failed to meet required sterility assurance levels during validation testing.

    Product
    Contra-Angle Torque Driver Kit For Certain and External Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1169-2014·2014-03-19

    Biomet 3i Recalls Dental Torque Driver Kits Due to Sterility Failure

    Biomet 3i is recalling 541 Contra-Angle Torque Driver Kits because the trays failed to meet required sterility assurance levels during validation testing.

    Product
    Contra-Angle Torque Driver Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1170-2014·2014-03-19

    Biomet 3i Recalls Dental Torque Driver Kits Due to Sterility Failure

    Biomet 3i is recalling 250 Contra-Angle Torque Driver Kits because the included surgical trays failed to meet required Sterility Assurance Levels during validation testing.

    Product
    Contra-Angle Torque Driver Kit For Certain Internal Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1168-2014·2014-03-19

    Biomet 3i Recalls Tapered Navigator Surgical Kits Due to Sterility Failure

    Biomet 3i is recalling 170 Tapered Navigator Certain Surgical Kits because the trays failed to meet required sterility assurance levels during validation testing.

    Product
    Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1125-2014·2014-03-12

    Novarel Injection Recalled for Sterility Assurance Concerns

    Natures Pharmacy & Compounding Center is recalling all non-expired lots of Novarel (IM) due to quality control issues affecting sterility assurance.

    Product
    Novarel (IM)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1115-2014·2014-03-12

    Gentamycin Injection Recalled Due to Sterility Assurance Concerns

    Natures Pharmacy & Compounding Center is recalling all lots of Gentamycin 80mg/1000cc 0.9% NS due to quality control issues affecting sterility assurance.

    Product
    Gentamycin 80mg/1000cc 0.9% NS
    Category
    Drug
    Distribution
    1 state