American Surgical Ultracot Sponges Recalled for Packaging Defect
American Surgical Company is recalling Ultracot sponges because defective packaging may compromise sterility. The recall covers 155 boxes 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 infection. This fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
American Surgical Company is recalling 155 boxes of Ultracot 20 mm x 60 mm (Glassine) sponges, reference number 23-09G. These sponges are used for neurosurgical and nonneurosurgical procedures. The recall is due to defective product packaging that compromises sterility.
The affected lots are 2015/09 AZ, 2015/10 AD, 2015/10 BQ, 2015/10 CQ, and 2015/11 AE. The products were distributed nationwide in the United States and internationally to Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, 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 instructions on return or replacement. The FDA has classified this as a Class II recall.
The recalled product
- Product
- American Surgical Ultracot 20 mm x 60 mm (Glassine) Ref Number: 23-09G Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Affected units
- 155
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: 2015/09 AZ 2015/10 AD 2015/10 BQ 2015/10 CQ 2015/11 AE
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 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
- HighAmerican Surgical Americot Blue Sponges Recalled for Packaging Sterility Defect
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