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.

1501–1525 of 2228

  • HighFDA (Devices)·Z-1767-2016·2016-06-01

    American Surgical Ray-Cot Sponges Recalled for Packaging Sterility Defects

    American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 165 boxes distributed worldwide.

    Product
    American Surgical Ray-Cot 1/2" x 1" Ref Number: 60-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1799-2016·2016-06-01

    American Surgical Cylindrical Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 11 boxes of cylindrical sponges because defective packaging may compromise sterility.

    Product
    American Surgical Cylindrical Sponges-Strung 1/2" x 1.5" Ref Number: 70-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1723-2016·2016-06-01

    American Surgical Sponges Recalled for Packaging Defect Compromising Sterility

    American Surgical Company is recalling Americot Blue sponges because defective packaging may compromise sterility. The recall covers 54 cases distributed worldwide.

    Product
    American Surgical Americot Blue 1/4" x 1/4" Ref Number: 20-01S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1820-2016·2016-06-01

    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.

    Product
    Various trauma and sports medicine instruments and implants. Reamer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1761-2016·2016-06-01

    American Surgical Cotton Balls Recalled for Packaging Sterility Defects

    American Surgical Company is recalling 3 boxes of 1-inch non-strung cotton balls due to packaging defects that compromise sterility.

    Product
    American Surgical Cotton Balls-Non-Strung 1" Ref Number: 31-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1817-2016·2016-06-01

    Biomet Recalls Trauma and Sports Medicine Implants 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. Plate, fixation, bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1787-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Sterility Defects

    American Surgical Company is recalling 409 boxes of Delicot sponges because defective packaging may compromise sterility.

    Product
    American Surgical Delicot 13 mm x 60 mm Ref Number: 63-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1745-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 45 boxes of Ultracot sponges because defective packaging may compromise sterility.

    Product
    American Surgical Ultracot 13 mm x 60 mm (Glassine) Ref Number: 23-08G Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1805-2016·2016-06-01

    American Surgical Telfa Sponges Recalled for Packaging Sterility Defects

    American Surgical Company is recalling Telfa 1" x 1" neurosurgical and nonneurosurgical sponges because defective packaging compromises sterility.

    Product
    American Surgical Telfa 1" x 1" Ref Number: 80-12 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1760-2016·2016-06-01

    American Surgical Cotton Balls Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 10 boxes of non-strung cotton balls due to packaging defects that compromise sterility.

    Product
    American Surgical Cotton Balls-Non-Strung 3/4" Ref Number: 31-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1810-2016·2016-06-01

    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 two boxes distributed worldwide.

    Product
    American Surgical Policot 1/2" x 2" Ref Number: 90-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1777-2016·2016-06-01

    American Surgical Delicot-J Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 27 boxes of Delicot-J sponges because defective packaging may compromise sterility.

    Product
    American Surgical Delicot-J 5 mm x 8 mm Ref Number: 63-01J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1753-2016·2016-06-01

    American Surgical Cotton Balls Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 87 boxes of strung cotton balls due to packaging defects that compromise sterility.

    Product
    American Surgical Cotton Balls-Strung 1/4" Ref Number: 30-00 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1802-2016·2016-06-01

    American Surgical Telfa Sponges Recalled for Packaging Defects Compromising Sterility

    American Surgical Company is recalling Telfa neurosurgical and nonneurosurgical sponges because defective packaging may compromise sterility.

    Product
    American Surgical Telfa 1/2" x 1.5" Ref Number: 80-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1768-2016·2016-06-01

    American Surgical Ray-Cot Sponges Recalled for Sterility Compromise

    American Surgical Company is recalling Ray-Cot sponges because defective packaging may have compromised sterility. The recall covers 28 boxes distributed worldwide.

    Product
    American Surgical Ray-Cot 1/2" x 1.5" Ref Number: 60-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1776-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 24 boxes of Delicot non-xray sponges because defective packaging compromises sterility.

    Product
    American Surgical Delicot non-xray 5 mm x 8 mm Ref Number: 63-01 Non X-Ray Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1783-2016·2016-06-01

    American Surgical Delicot-J Sponges Recalled for Sterility Compromise

    American Surgical Company is recalling 68 boxes of Delicot-J sponges because defective packaging compromises sterility. The products were distributed worldwide.

    Product
    American Surgical Delicot-J 15 mm x 20 mm Ref Number: 63-04J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1736-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 114 cases of Ultracot sponges because defective packaging compromises sterility.

    Product
    American Surgical Ultracot 5 mm x 8 mm Ref Number: 23-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1744-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 23 boxes of Ultracot sponges because defective packaging may compromise sterility. The product is distributed worldwide.

    Product
    American Surgical Ultracot 13 mm x 60 mm Ref Number: 23-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1729-2016·2016-06-01

    American Surgical Americot Blue Sponges Recalled for Packaging Defects

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

    Product
    American Surgical Americot Blue 3/8" x 3/4" Ref Number: 20-14S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1806-2016·2016-06-01

    American Surgical Telfa Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Telfa 1" x 3" sponges because defective packaging compromises sterility. The recall covers 57 boxes distributed worldwide.

    Product
    American Surgical Telfa 1" x 3" Ref Number: 80-13 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1801-2016·2016-06-01

    American Surgical Telfa Sponges Recalled for Packaging Sterility Defects

    American Surgical Company is recalling Telfa 1/2" x 1/2" sponges because defective packaging may compromise sterility. The recall covers 24 boxes distributed worldwide.

    Product
    American Surgical Telfa 1/2" x 1/2" Ref Number: 80-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1721-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Sterility Defects

    American Surgical Company is recalling 351 boxes of Delicot sponges because defective packaging may compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Delicot 15mm x 20mm Ref: 63-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1746-2016·2016-06-01

    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 products were distributed worldwide.

    Product
    American Surgical Ultracot 20 mm x 60 mm Ref Number: 23-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1762-2016·2016-06-01

    American Surgical Cotton Balls Recalled Due to Packaging Sterility Defect

    American Surgical Company is recalling 7 boxes of non-strung cotton balls due to packaging defects that compromise sterility. The affected lots were distributed worldwide.

    Product
    American Surgical Cotton Balls-Non-Strung 1/8" Ref Number: 31-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide