Sofsilk Braided Silk sutures — Class II medical device recall Z-1697-2024
Ongoing recall by Covidien, LP, reported 2024-05-08. One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. T
| Recall number | Z-1697-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, LP, North Haven, CT, United States |
| Recall initiated | 2024-01-25 |
| Classified | 2024-04-29 |
| Reported by FDA | 2024-05-08 |
| Countries outside the US | IT, PT |
| Quantity | 36 total |
| Reason classes | chemical contamination, potency |
| UPC / GTIN / UDI-DI | 20884521086422 |
| Lot numbers | D2F2101RY |
Product
Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk fibers, for use in soft tissue approximation and/or ligation.
Reason for recall
One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which could result in harms such as wound dehiscence, hemorrhage, blood loss, bleeding, tissue breakdown, peritonitis, unspecified infection, vision loss (when used in ophthalmic application), and/or prolonged surgery.
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-1697-2024. 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.