The Recall Desk

Hazard

Sterility Assurance Failure recalls

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

What the numbers show

Total
55
Critical
0
Severe
14
Most recent
2026-05-13

Of the 55 sterility assurance failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 14 (25%) 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 assurance 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.

51–55 of 55

  • SevereFDA (Drugs)·D-0002-2022·2021-10-13

    Artesunate for Injection Recalled Due to Sterility Assurance Failure

    AMIVAS (US), LLC is recalling Artesunate for Injection (110 mg/vial) because an air filter failed post-integrity testing, creating a lack of sterility assurance for the product.

    Product
    Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Single-dose vials artesunate (73607-001-01) and 2 vials sterile diluent (NDC 73607-001-02) per carton (NDC 73607-001-11); 4x4 pack containing 4 Single-dose vials artesunate (73607-001-01) and 4 vials ster
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0741-2021·2021-08-25

    Metoclopramide Injection Vials Recalled for Lack of Sterility Assurance

    Teva Pharmaceuticals USA is recalling 25,653 vials of Metoclopramide Injection USP due to lack of assurance of sterility. The affected vials were distributed nationwide, including Puerto Rico.

    Product
    METOCLOPRAMIDE — METOCLOPRAMIDE (METOCLOPRAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0692-2021·2021-07-28

    Compounded Semorelin/Ipamorelin Injection Recalled for Sterility Assurance

    Innoveix Pharmaceuticals is recalling 728 vials of compounded Semorelin/Ipamorelin 3 mg injection due to lack of assurance of sterility. The affected lots are SIP215, SIP220, and SIP210.

    Product
    Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1674-2019·2019-06-05

    Maquet Getinge Custom Neonatal ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific neonatal extracorporeal circulation tubing sets because a design feature may prevent proper sterilization gas flow, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 50900 Custom ECC Pack-Neonatal ¿ Material: 709000069R02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1517-2019·2019-06-05

    Maquet Getinge-BEQ-TOP 5502 ECC Pack Recall for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of ECC packs because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 5502 ECC Pack Material: 701051791
    Category
    Medical Device
    Distribution
    Distributed nationwide