Hazard

Sterility Verification recalls

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

What the numbers show

Total: 13
Critical: 0
Severe: 0
Most recent: 2012-11-28

Of the 13 sterility verification 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 sterility verification 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.

1–13 of 13

ModerateFDA (Devices)·Z-0335-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled Due to Missing Sterility Audit Records
Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation to verify quarterly dose sterility audits is unavailable.
Product
Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 3.0%, Part# 9300-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, eit
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0334-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled for Sterility Audit Documentation Gaps
Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation is missing to verify that required quarterly dose sterility audits were performed.
Product
Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capilla
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0331-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled for Missing Sterility Audit Documentation
Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation is missing to verify that required quarterly sterility audits were performed.
Product
Superstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget, 1.5%, Part#9500-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, eithe
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0340-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled for Missing Sterility Audit Documentation
Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation verifying quarterly dose sterility audits is unavailable.
Product
Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 1.5%, Part# 9300-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, eith
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0341-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled for Missing Sterility Audit Documentation
Superstat Corp is recalling 26,422 units of Modified Collagen Hemostatic Sponge because documentation verifying quarterly dose sterility audits is unavailable.
Product
Superstat Modified Collagen Hemostatic Sponge, 7.5mm x 19mm Cone, 3.0%, Part# 9015-30, 9003-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleedin
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0342-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled Due to Missing Sterility Documentation
Superstat Corp is recalling 26,422 units of Modified Collagen Hemostatic Sponge because documentation verifying quarterly dose sterility audits is unavailable.
Product
Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 3.0%, Part# 9100-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capilla
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0336-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled for Missing Sterility Audit Documentation
Superstat Corp is recalling 26,422 units of Modified Collagen Hemostatic Sponge because documentation verifying quarterly dose sterility audits is unavailable.
Product
Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 1.5%, Part# 9105-00. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capil
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0337-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled Due to Missing Sterility Audit Documentation
Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation verifying quarterly dose sterility audits is unavailable.
Product
Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 3.0%, Part# 9106-00. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capi
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0338-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled for Sterility Audit Documentation Issues
Superstat Corp is recalling 26,422 units of Modified Collagen Hemostatic Sponge because documentation verifying quarterly dose sterility audits is unavailable.
Product
Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, Part# 9102-00. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capil
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0343-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled for Sterility Documentation Issues
Superstat Corp is recalling 26,422 units of Modified Collagen Hemostatic Sponge because documentation verifying quarterly dose sterility audits is unavailable.
Product
Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capilla
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0332-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled Due to Missing Sterility Audit Records
Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation verifying quarterly dose sterility audits is unavailable.
Product
Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 1.5%, Part# 9200-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capilla
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0333-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled Due to Missing Sterility Audit Documentation
Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation verifying quarterly dose sterility audits is unavailable.
Product
Superstat Modified Collagen Hemostatic Sponge, 115mm x 115mm Pledget, 3.0%, Part# 9500-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, ei
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0339-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled Due to Missing Sterility Audit Records
Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation verifying quarterly dose sterility audits is unavailable.
Product
Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 1.5%, Part# 9120-15, 9100-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, eithe
Category
Medical Device
Distribution
Distributed nationwide