The Recall Desk

Hazard

Sterilization Breach recalls

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

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2016-05-11

Of the 5 sterilization breach 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.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterilization breach 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.

1–5 of 5

  • HighFDA (Devices)·Z-1610-2016·2016-05-11

    Applied Medical Recalls Wilson Penile Implantation System Retractor Frame

    Applied Medical Technology Inc is recalling Wilson Penile Implantation System Retractor Frames due to a reported open pouch that breaches sterilization validation.

    Product
    Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1611-2016·2016-05-11

    Applied Medical Recalls Wilson Implantation System Due to Sterilization Breach

    Applied Medical Technology Inc is recalling 1,100 units of the Wilson Implantation System after a complaint revealed an open pouch that breached sterilization validation.

    Product
    Wilson Implantation System Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1609-2016·2016-05-11

    Applied Medical Technology Recalls Self-Retaining Retractor Frames Due to Sterilization Breach

    Applied Medical Technology is recalling 3,754 units of TLC Self-Retaining Retractor Frames because a complaint reported an open pouch, which breaches sterilization validation.

    Product
    TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize. Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1608-2016·2016-05-11

    Applied Medical Recalls TLC Self Retaining Retractor Systems Due to Sterilization Breach

    Applied Medical Technology Inc is recalling 5,334 units of TLC Self Retaining Retractor Systems because a complaint reported an open pouch that breaches sterilization validation.

    Product
    TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0826-2014·2014-02-05

    Navilyst Medical Recalls Port Kits Due to Sterilization Barrier Breach

    Navilyst Medical is recalling 920 Port Kits with Access Infusion Sets due to a possible breach of the sterilization barrier. The devices were distributed nationwide.

    Product
    Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalog Number 45-014; 2) 8F/SL/Titanium Ports/NF, Product Number H965450170, Catalog Number 45-017; 3) 6F/SL/Plastic Port/F, Product Number H965450200, Catalog…
    Category
    Medical Device
    Distribution
    Distributed nationwide