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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where defective packaging compromises sterility, creating a risk of harm (infection) without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
American Surgical Company is recalling 32 boxes of Ultracot 9 mm x 50 mm (Glassine) sponges, Reference Number 23-07G. These neurosurgical and nonneurosurgical sponges are being recalled because defective packaging may compromise the sterility of the product.
The affected lot numbers are 2015/10 CF and 2015/12 AO. The products were distributed worldwide, including in the United States, Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, the Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and the United Kingdom.
Healthcare facilities and consumers should stop using these sponges and contact American Surgical Company for further instructions.
The recalled product
- Product
- American Surgical Ultracot 9 mm x 50 mm (Glassine) Ref Number: 23-07G Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Affected units
- 32
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot numbers: 2015/10 CF 2015/12 AO
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 91 recalled by American Surgical Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 91 products in this recall →Related recalls
Same manufacturer · American Surgical Company
See all →- HighAmerican Surgical Americot Blue Sponges Recalled for Packaging Sterility Defect
FDA (Devices) · 2016-06-01
- HighAmerican Surgical Ultracot Sponges Recalled for Packaging Defect
FDA (Devices) · 2016-06-01
- HighAmerican Surgical Ultracot Sponges Recalled for Packaging Sterility Defect
FDA (Devices) · 2016-06-01
- HighAmerican Surgical Ray-Cot Sponges Recalled for Packaging Sterility Defects
FDA (Devices) · 2016-06-01
- HighAmerican Surgical Ray-Cot Sponges Recalled for Sterility Compromise
FDA (Devices) · 2016-06-01
Same hazard · sterility compromise
See all →- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12