American Surgical Cotton Balls Recalled for Packaging Sterility Defect
American Surgical Company is recalling 182 boxes of 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 packaging defects compromise sterility, creating a risk of infection or harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
American Surgical Company is recalling 182 boxes of American Surgical Cotton Balls-Strung 1/2" (Ref Number: 30-02). The product is used for neurosurgical and nonneurosurgical sponges. The recall is due to defective product packaging that compromises sterility.
The affected lot number is 2015/09 BN. The products were distributed worldwide, including 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.
Healthcare facilities and consumers should stop using the affected products and contact American Surgical Company for instructions on return or replacement.
The recalled product
- Product
- American Surgical Cotton Balls-Strung 1/2" Ref Number: 30-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Affected units
- 182
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 BN
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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