American Surgical Americot Blue Sponges Recalled for Packaging Defects
American Surgical Company is recalling Americot Blue sponges because defective packaging compromises sterility. The recall covers 24 boxes 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 harm (infection) without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
American Surgical Company is recalling 24 boxes of Americot Blue 3/8" x 3/8" sponges, reference number 20-22S. These neurosurgical and nonneurosurgical sponges are being recalled because defective product packaging compromises sterility.
The affected products are identified by lot numbers 2015/10 AR and 2015/11 BX. The recall covers distribution in the United States and internationally, including 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 sponges and contact American Surgical Company for instructions on return or replacement. The FDA has classified this as a Class II recall.
The recalled product
- Product
- American Surgical Americot Blue 3/8" x 3/8" Ref Number: 20-22S Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Affected units
- 24
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 AR 2015/11 BX
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.
See all 91 products in this recall →Related recalls
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