American Surgical Cotton Balls Recalled for Packaging Sterility Defects
American Surgical Company is recalling 3 boxes of 1-inch non-strung cotton balls due to packaging defects that compromise sterility.
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 a defect compromises sterility, creating a risk of harm (infection) even though no injuries have been reported yet, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
American Surgical Company is recalling 3 boxes of American Surgical Cotton Balls-Non-Strung 1" (Ref Number: 31-04). These products are intended for use as neurosurgical and nonneurosurgical sponges. The specific lot number affected is 2015/10 BR.
The recall was initiated because the product packaging is defective, which compromises the sterility of the cotton balls. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.
The affected products were distributed worldwide, including the United States and various countries in Europe, Asia, Africa, and the Middle East. Consumers and healthcare facilities should stop using the affected lot and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- American Surgical Cotton Balls-Non-Strung 1" Ref Number: 31-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Affected units
- 3
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 BR
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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