Recall archive / FDA device enforcement
Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed ... — FDA record Z-1697-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 25, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- 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.
- Classification
- Class II
- Recalling firm
- Covidien, LP
- Quantity
- 36 total, OUS distribution only
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1697-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI 20884521086422 Lot D2F2101RY |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution in the countries of Portugal and Italy.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- May 8, 2024
- Recall initiation date
- Jan 25, 2024
- Center classification date
- Apr 29, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.