The Recall Desk

Hazard

Sterility Compromise recalls

2,228 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,228
Critical
3
Severe
255
Most recent
2026-08-19

Of the 2,228 sterility compromise recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (11%) 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 sterility compromise 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.

1451–1475 of 2228

  • HighFDA (Devices)·Z-1733-2016·2016-06-01

    American Surgical Americot Blue Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 22 boxes of Americot Blue sponges because defective packaging may compromise sterility.

    Product
    American Surgical Americot Blue 1/4" x 1.5" Ref Number: 20-30S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1751-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Defect Compromising Sterility

    American Surgical Company is recalling 33 boxes of Ultracot sponges because defective packaging may compromise sterility. The affected products were distributed worldwide.

    Product
    American Surgical Ultracot 30 mm x 90 mm (Glassine) Ref Number: 23-15G Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1732-2016·2016-06-01

    American Surgical Americot Blue Sponges Recalled for Packaging Defects

    American Surgical Company is recalling 15 boxes of Americot Blue sponges because defective packaging compromises sterility.

    Product
    American Surgical Americot Blue 3/8" x 2" Ref Number: 20-26S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1789-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Delicot sponges because defective packaging may compromise sterility. The recall covers 343 boxes distributed worldwide.

    Product
    American Surgical Delicot 20 mm x 60 mm Ref Number: 63-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1825-2016·2016-06-01

    Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects

    Biomet is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead to infection.

    Product
    Various trauma and sports medicine instruments and implants. Appliance, fixation, nail/blade/plate combination, multiple component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1771-2016·2016-06-01

    American Surgical Ray-Cot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 209 boxes distributed worldwide.

    Product
    American Surgical Ray-Cot 1" x 3" Ref Number: 60-13 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1798-2016·2016-06-01

    American Surgical Uniqcot Sponges Recalled for Packaging Defect Compromising Sterility

    American Surgical Company is recalling Uniqcot sponges because defective packaging may compromise sterility. The recall covers 3 boxes distributed worldwide.

    Product
    American Surgical Uniqcot 1/2" x 2" Ref Number: 67-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1735-2016·2016-06-01

    American Surgical Recalls Americot Blue Sponges Due to Packaging Defects

    American Surgical Company is recalling 37 boxes of Americot Blue sponges because defective packaging may compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Americot Blue 1/2" x 2" Ref Number: 20-32S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1752-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 27 boxes of Ultracot sponges because defective packaging may compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Ultracot 70 mm x 10090 mm Ref Number: 23-24 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1773-2016·2016-06-01

    American Surgical Ray-Cot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 27 boxes distributed worldwide.

    Product
    American Surgical Ray-Cot 1.5" x 3" Ref Number: 60-22 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1734-2016·2016-06-01

    American Surgical Americot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Americot White sponges because defective packaging may compromise sterility. The recall covers 35 boxes distributed worldwide.

    Product
    American Surgical Americot White 1.5 cm x 5.5 cm Ref Number: 20-31SW Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1779-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 21 boxes of Delicot non-xray sponges because defective packaging may compromise sterility.

    Product
    American Surgical Delicot non-xray 5 mm x 13 mm Ref Number: 63-02 non-xray Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1778-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 97 boxes of Delicot 5 mm x 13 mm sponges because defective packaging may compromise sterility.

    Product
    American Surgical Delicot 5 mm x 13 mm Ref Number: 63-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1807-2016·2016-06-01

    American Surgical Policot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Policot sponges because defective packaging may compromise sterility. The recall covers 3 boxes distributed worldwide.

    Product
    American Surgical Policot 1/4" x 1/4" Ref Number: 90-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1772-2016·2016-06-01

    American Surgical Ray-Cot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 16 boxes distributed worldwide.

    Product
    American Surgical Ray-Cot 3" x 3" Ref Number: 60-15 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1741-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 39 boxes of Ultracot sponges because defective packaging may compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Ultracot 15 mm x 20 mm (Glassine) Ref Number: 23-04G Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1796-2016·2016-06-01

    American Surgical Uniqcot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Uniqcot sponges because defective packaging may compromise sterility. The recall covers 4 cases distributed worldwide.

    Product
    American Surgical Uniqcot 1/2" x 1.5" Ref Number: 67-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1743-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Defects Compromising Sterility

    American Surgical Company is recalling 32 boxes of Ultracot sponges because defective packaging may compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Ultracot 9 mm x 50 mm (Glassine) Ref Number: 23-07G Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1730-2016·2016-06-01

    American Surgical Recalls Americot Blue Sponges Due to Packaging Defect

    American Surgical Company is recalling Americot Blue sponges because defective packaging compromises sterility. The recall affects 4 boxes distributed worldwide.

    Product
    American Surgical Americot Blue 1/8" x 1/8" Ref Number: 20-19S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1784-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Defect Compromising Sterility

    American Surgical Company is recalling 99 units of Delicot 4 mm x 50 mm sponges because defective packaging may compromise sterility.

    Product
    American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1819-2016·2016-06-01

    Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects

    Biomet, Inc. is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile barrier packaging could compromise sterility.

    Product
    Various trauma and sports medicine instruments and implants. Rod, fixation, intramedullary and accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1808-2016·2016-06-01

    American Surgical Policot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Policot sponges because defective packaging may compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Policot 1/2" x 1/2" Ref Number: 90-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1826-2016·2016-06-01

    Biomet Recalls Trauma and Spinal Implants Due to Sterile Seal Defects

    Biomet is recalling various trauma, sports medicine, and spinal implants because insufficient seal strength may compromise sterility, potentially leading to infection.

    Product
    Various trauma and sports medicine instruments and implants. Spinal interlaminal fixation orthosis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1794-2016·2016-06-01

    American Surgical Uniqcot Sponges Recalled for Sterility Compromise

    American Surgical Company is recalling 39 boxes of Uniqcot sponges because defective packaging may compromise sterility.

    Product
    American Surgical Uniqcot 1/4" x 1/4" Ref Number: 67-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1728-2016·2016-06-01

    American Surgical Recalls Sponges Due to Packaging Sterility Defect

    American Surgical Company is recalling 103 boxes of Americot Blue sponges because defective packaging may compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Americot Blue 1" x 3" Ref Number: 20-10S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide