The Recall Desk

Hazard

Unvalidated Sterilization recalls

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

What the numbers show

Total
7
Critical
0
Severe
0
Most recent
2026-06-17

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

1–7 of 7

  • HighFDA (Devices)·Z-2407-2026·2026-06-17

    Halyard pain packs shipped without validated sterilization in Iowa

    Halyard Pain Packs, kit code AMPK48-01, are being recalled because sealed pouches that had not undergone validated sterilization were inadvertently distributed. 120 kits affected.

    Product
    Halyard, Pain Pack. Kit Code: AMPK48-01.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2409-2026·2026-06-17

    Halyard drape packs shipped without undergoing validated sterilization process

    Halyard Drape Packs, kit code LMDP36-01, are being recalled because sealed pouches that had not undergone validated sterilization were inadvertently distributed. 72 kits affected.

    Product
    Halyard, Drape Pack. Kit Code: LMDP36-01.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2408-2026·2026-06-17

    Halyard towel six packs shipped without validated sterilization in Iowa

    Halyard Towel Six Packs, kit code AMTS70-01, are being recalled because sealed pouches that had not undergone validated sterilization were inadvertently distributed. 224 kits affected.

    Product
    Halyard, Towel Six Pack. Kit Code: AMTS70-01.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2410-2026·2026-06-17

    Halyard eye bag packs shipped without validated sterilization in Iowa

    Halyard Eye Bag Packs, kit code UIEB48-01, are being recalled because sealed pouches that had not undergone validated sterilization were inadvertently distributed. 60 kits affected.

    Product
    Halyard, Eye Bag Pack. Kit Code: UIEB48-01.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0977-2023·2023-08-09

    Heparin IV bags recalled for lack of validated sterility assurance

    Central Admixture Pharmacy Services is recalling 7,509 heparin IV bags nationwide because the company lacks validation data showing the sterilization process works. No illnesses have been reported.

    Product
    heparin 2500 units/500mL added to 0.9% sodium chloride 5 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8100-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1701-2022·2022-09-14

    Obstetric and gynecology surgical packs recalled for unvalidated sterilization exposure

    American Contract Systems is recalling 15 obstetric and gynecology surgical packs that underwent multiple sterilization cycles without validation. This could compromise product sterility and increase infection risk during procedures.

    Product
    Various ob/gyn packs
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0395-2018·2018-01-31

    Measurement Specialties Reusable Temperature Probes Recalled for Unvalidated Sterilization Instructions

    Measurement Specialties Inc. is recalling 6,076 reusable temperature probes because their sterilization instructions have not been proven through a validation study.

    Product
    Measurement Specialties Reusable Temperature Probe Autoclavable. Sold as Esophageal/Rectal (Adult), Esophageal/Rectal (Pediatric), and Skin (Adult) Intended for use by a licensed physician to continuously monitor human esophageal, rectal, or skin temperature. They are designe
    Category
    Medical Device
    Distribution
    Distributed nationwide