Sofsilk Braided Silk Sutures (Unknown) – Sterilization Exposure (2024)
Excessive sterilization cycles can decrease suture tensile strength.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Lot Codes / Batch Numbers
UDI-DI 20884521086422 Lot D2F2101RY
Products Sold
UDI-DI 20884521086422 Lot D2F2101RY
A medical device manufacturer is recalling Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026