American Surgical Telfa Sponges Recalled for Packaging Sterility Defects
American Surgical Company is recalling Telfa sponges because defective packaging may compromise sterility. The recall covers 178 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 infection. This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
American Surgical Company is recalling 178 boxes of Telfa 1/2" x 3" sponges (Ref Number: 80-09) used for neurosurgical and nonneurosurgical procedures. The recall was initiated because the product packaging is defective, which may compromise the sterility of the sponges.
The affected lots are 2015/09 CC, 2015/10 BL, 2015/12 BI, 2016/01 AP, and 2015/12 CZ. These products were distributed nationwide in the United States and in numerous international markets, including Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, the Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and the United Kingdom.
Healthcare providers and consumers should stop using the affected sponges and contact American Surgical Company for instructions on return or replacement. The U.S. Food and Drug Administration has classified this as a Class II recall.
The recalled product
- Product
- American Surgical Telfa 1/2" x 3" Ref Number: 80-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Affected units
- 178
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 CC 2015/10 BL 2015/12 BI 2016/01 AP 2015/12 CZ
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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