American Surgical Cotton Balls Recalled for Packaging Sterility Defects
American Surgical Company is recalling 237 units of 1-inch 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 with a defect compromising sterility, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
American Surgical Company is recalling 237 units of American Surgical Cotton Balls-Strung 1" (Ref Number: 30-04). These products are used as neurosurgical and nonneurosurgical sponges. The recall is being conducted because the product packaging is defective, which compromises the sterility of the cotton balls.
The affected lots are 2015/08 AI, 2015/09 AA, 2015/09 CL, 2015/10 AT, 2015/11 CH, 2015/12 CB, and 2015/12 AJ. 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 consumers should stop using these products immediately and contact American Surgical Company for instructions on how to return the items.
The recalled product
- Product
- American Surgical Cotton Balls-Strung 1" Ref Number: 30-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Affected units
- 237
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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