American Surgical Cotton Balls Recalled for Packaging Sterility Defect
American Surgical Company is recalling 87 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 risk-of-harm product (sterile surgical sponges) where the defect compromises sterility, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
American Surgical Company is voluntarily recalling 87 boxes of American Surgical Cotton Balls-Strung 1/4" (Ref Number: 30-00). These products are intended for use as neurosurgical and nonneurosurgical sponges.
The recall was initiated because the product packaging is defective, which compromises the sterility of the cotton balls. The affected lot numbers are 2015/09 CM, 2015/11 AO, and 2015/12 BR.
The 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. Healthcare facilities and distributors should stop using the affected products and contact the recalling firm for instructions.
The recalled product
- Product
- American Surgical Cotton Balls-Strung 1/4" Ref Number: 30-00 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Hazard
- Affected units
- 87
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 CM 2015/11 AO 2015/12 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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