The Recall Desk

Hazard

Lack Of 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
2
Most recent
2018-08-01

Of the 7 lack of 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 2 (29%) 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 lack of 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-0577-2018·2018-02-21

    Smiths Medical Recalls Single Custom Tracheostomy Device for Missing Sterilization

    Smiths Medical is recalling one custom tracheostomy device that was shipped without required sterilization. The device was distributed to a customer in Germany.

    Product
    Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pumps to allow fluid delivery from an IV bag.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0984-2017·2017-01-18

    Medline E-Z Lubricating Jelly Recalled Due to Lack of Sterilization

    Medline is recalling 12,024 tubes of E-Z Lubricating Jelly because they were not sterilized due to a shipping error.

    Product
    Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1327-2015·2015-04-01

    Ameda Dual Short Term HygieniKit Milk Collections System Recalled for Lack of Sterilization

    Ameda is recalling its Dual Short Term HygieniKit Milk Collections System because the devices were not sterilized. Consumers should stop using the product and contact the manufacturer.

    Product
    Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouches with Tyvek header (10.75 x 16.375 x 3") within a secondary corrugated shipper (20.75 x 15.50 x 8.5" inner dimensions). The device is intended to be connected to a powered breas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1656-2013·2013-07-10

    HealthLink Recalls Biopsy Punches Due to Lack of Sterilization

    Clorox Healthcare Holdings is recalling 772,600 units of Argent Surgical Systems Biopsy Punches because they were not sterilized.

    Product
    ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1654-2013·2013-07-10

    HealthLink Biopsy Punches Recalled for Lack of Sterilization

    Clorox Healthcare Holdings is recalling HealthLink Biopsy Punches because they were not sterilized. The recall affects 1,044,600 units distributed in the US, Canada, Mexico, and New Zealand.

    Product
    HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1655-2013·2013-07-10

    HealthLink Biopsy Punches Recalled for Lack of Sterilization

    Clorox Healthcare Holdings is recalling 1,032,700 units of PSS Select Biopsy Punches because they were not sterilized. The products were distributed nationwide and in Canada, Mexico, and New Zealand.

    Product
    PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.
    Category
    Medical Device
    Distribution
    Distributed nationwide