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.
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 (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.
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