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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 (risk-of-harm product) without reported injuries, which aligns with the High severity criteria.
Plain-English summary
American Surgical Company is recalling 33 boxes of Ultracot 20 mm x 60 mm sponges (Ref Number: 23-09, Lot 2015/08 CJ). These neurosurgical and nonneurosurgical sponges are being recalled because defective packaging may compromise the sterility of the product.
The affected products were distributed worldwide, including in the United States, 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.
Consumers and healthcare facilities should stop using the affected sponges and contact American Surgical Company for instructions on return or replacement.
The recalled product
- Product
- American Surgical Ultracot 20 mm x 60 mm Ref Number: 23-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Affected units
- 33
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: 2015/08 CJ
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 →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- SevereCurity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach
FDA (Devices) · 2016-06-08
- SevereCurity All Purpose Sponges Recalled Due to Compromised Sterility
FDA (Devices) · 2016-06-08
- HighMedical Action Industries Recalls Laparotomy Sponges Due to Sterility Concerns
FDA (Devices) · 2019-04-03
- HighNeurological surgical kits may have compromised packaging sterility
FDA (Devices) · 2022-04-13
- HighMedical Action Industries Recalls Laparotomy Sponges Due to Sterility Compromise
FDA (Devices) · 2019-01-02
- SevereCustomed Recalls Universal Surgical Packs Due to Packaging Integrity Concerns
FDA (Devices) · 2014-09-10