FDA Medical Device Recalls (openFDA)
Covidien, LP: 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.
- Recall number
- Z-1697-2024
- Recalling firm
- Covidien, LP
- 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.
- Status
- Open, Classified
- Initiated
- 2024-01-25
- Posted
- 2024-04-29
- Terminated
- not on file
- 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.
- Root cause
- Process control
- Action
- On January 25, 2024, Medtronic issued an expansion to their earlier recall for sutures (RES 93768) concerning gamma sterilization. As part of that expansion, there was an additional lot of product which was exposed to more than the approved number of EO sterilization cycles, which is covered in this recall, RES 94351. The issue was communicated to affected consignees via letters. Consignees are asked to return any affected product they may have, forward this notification to those who need to be aware within the organization and to any location which the devices have been transferred.
- Quantity
- 36 total, OUS distribution only
- Distribution
- International distribution in the countries of Portugal and Italy.
- Lot, serial or model codes
- UDI-DI 20884521086422 Lot D2F2101RY
- 510(k) numbers
- ["K981128"]
- PMA numbers
- not on file
- Product code
- GAP
- Firm FEI
- 1219930
- Firm city
- North Haven
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28