The Recall Desk

Hazard

Sterilization Failure recalls

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

What the numbers show

Total
580
Critical
3
Severe
38
Most recent
2026-10-14

Of the 580 sterilization failure recalls we have scored against our rubric, 3 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 38 (7%) 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 sterilization 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.

576–580 of 580

  • HighFDA (Devices)·Z-0423-2013·2012-11-28

    King Systems Recalls Laryngeal Airway Devices Due to Sterilization Indicator Failure

    King Systems Corp. is recalling 2,630 laryngeal airway devices because sterilization indicators failed to change color, suggesting the devices may not be sterile.

    Product
    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal King LAD¿ Patient Size: 50-70kg Product Usage: Laryngeal airway
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0424-2013·2012-11-28

    King Systems Recalls Laryngeal Airway Devices Due to Sterilization Indicator Issues

    King Systems Corp. is recalling specific lots of Laryngeal Airway Devices because sterilization indicators failed to change color as expected, potentially indicating improper sterilization.

    Product
    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 5 / Adult ClearSeal King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0427-2013·2012-11-28

    King Systems Recalls Flexible ClearSeal Laryngeal Airway Devices

    King Systems Corp. is recalling 2,630 Flexible ClearSeal Laryngeal Airway Devices due to EtO sterilization indicators that failed to change color.

    Product
    KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible King LAD¿ Patient Size: 50-70kg " Product Usage: Laryngeal airway
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0425-2013·2012-11-28

    King Systems Recalls Infant Laryngeal Airway Devices Due to Sterilization Indicator Issues

    King Systems Corp. is recalling 2,630 infant laryngeal airway devices because sterilization indicators failed to change color as expected, raising concerns about proper ethylene oxide sterilization.

    Product
    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1792-2012·2012-06-20

    MicroAire Lipofilter 3000 Canisters Recalled for Sterilization Defects

    MicroAire Surgical Instruments is recalling 15 Lipofilter 3000 fat collection canisters because they were not manufactured under Good Manufacturing Procedures, potentially preventing proper sterilization.

    Product
    Lipofilter 3000, model ASP-CAN-2, labeled in part ***MicroAire, 1641 Edlich Drive, Charlottesville, VA 22911, USA*** Product Usage: A fat collection canister intended for use during liposuction procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide