The Recall Desk

Hazard

Sterility recalls

2,384 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,384
Critical
1
Severe
2,114
Most recent
2026-09-09

Of the 2,384 sterility recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,114 (89%) 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 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.

2376–2384 of 2384

  • HighFDA (Drugs)·D-122-2013·2013-01-09

    New England Compounding Center Recalls Omnipaque Vials Due to Sterility Concerns

    New England Compounding Center is recalling Omnipaque vials nationwide because the company cannot ensure the product is sterile.

    Product
    Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-105-2013·2013-01-02

    Roche Recalls Cymevene Powder for Infusion Due to Sterility Concerns

    F. Hoffmann-LaRoche Ltd. is recalling Cymevene 500 mg Powder for Infusion due to container closure issues that compromise sterility assurance. No product was distributed in the USA.

    Product
    Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed), Rx only, 10 mL vials, Roche Products Limited, Welwyn Garden City, AL7 1TW, United Kingdom
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-096-2013·2012-12-26

    Hospira Recalls Nalbuphine Hydrochloride Injection Due to Sterility Concerns

    Hospira is recalling 145,400 vials of Nalbuphine Hydrochloride Injection because loose crimps and missing stoppers prevent assurance of sterility.

    Product
    NALBUPHINE HYDROCHLORIDE — NALBUPHINE HYDROCHLORIDE (NALBUPHINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0568-2013·2012-12-26

    Medline Angio Drape Pack Recall Due to Sterility Misidentification

    Medline is recalling 105 Angio Drape Packs because a non-sterile waste bag was assumed to be sterile by customers.

    Product
    Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescription procedure pack, including a waste bag, for use by the Interventional Radiology Department; Packaged for Medline Industries, Inc.; Reorder #DYNJ35993D This custom pack includes components necess
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2288-2012·2012-09-05

    Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns

    Unimed Surgical Products is recalling specific lots of Medline electrosurgical electrodes due to concerns regarding sterility.

    Product
    Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle with Extended Insulation 4.0" (10.16cm) Length***Reorder: ES0016AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1651-2012·2012-08-29

    Custom US Breast Core Biopsy Tray Recalled for Sterility Concerns

    Custom Medical Specialties is recalling 25 breast biopsy trays because they contain saline bags subject to a separate recall for leaking.

    Product
    CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Manufactured by: CMS Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine Level, NC 27568, the tray also contains other components not listed in this product description.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1649-2012·2012-08-29

    Custom Medical Specialties Recalls Sterile Access Trays Due to Sterility Concerns

    Custom Medical Specialties is recalling 35 sterile access trays because they contain sodium chloride bags subject to a separate recall for leaking.

    Product
    Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #: CMS-1667-R2(94-2478), Manufactured for KM Medical, Inc., 124 Jewett Street, Georgetown, MA 01833, the tray also contains other components not listed in this product description.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1650-2012·2012-08-29

    CMS-8934 Custom Phlebectomy Tray Recalled Due to Sterility Assurance Concerns

    Custom Medical Specialties is recalling 20 sterile phlebectomy trays because they contain sodium chloride bags subject to a separate recall for leaking.

    Product
    CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 mL, Manufactured by: CMS, Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine level, NC 27568, the tray also contains other components not listed in this product description.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1525-2012·2012-08-22

    Furosemide Injectable Recall Due to Sterility Assurance Issues

    Franck's Lab Inc. is recalling furosemide injectable products because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    FUROSEMIDE*** (25X10ML) 10MG/ML INJECTABLE 250 ML; FUROSEMIDE*** (25X4ML) 10MG/ML INJECTABLE 2 VIAL (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide