American Surgical Telfa 3/8" x 3" Ref Number: 80-05 Product Usage:… — Class II medical device recall Z-1800-2016
Terminated recall by American Surgical Company, reported 2016-06-01, distributed nationwide. Product packaging defective compromising sterility
| Recall number | Z-1800-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Surgical Company, Salem, MA, United States |
| Recall initiated | 2016-03-31 |
| Classified | 2016-05-26 |
| Reported by FDA | 2016-06-01 |
| Terminated | 2016-10-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CH, DE, ES, FR, GB, GR, HK, IL, IT, JP, NL, NZ, PT, SA, SE, ZA |
| Quantity | 11 boxes |
| Reason classes | sterility, packaging |
| Lot numbers | 2015/12AD |
| Model numbers | 80-05 |
Product
American Surgical Telfa 3/8" x 3" Ref Number: 80-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Reason for recall
Product packaging defective compromising sterility
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1800-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.