Covidien recalls Sofsilk Braided Silk sutures (Product S-2782K) due to potential tensile strength reduction from excessive ethylene oxide sterilization cycles, which may cause wound complications.
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.
Covidien is recalling Sofsilk Braided Silk sutures (Product Number S-2782K) because one lot was exposed to too many ethylene oxide sterilization cycles. This could weaken the sutures over time, leading to wound dehiscence, bleeding, or other complications during surgery.
The sutures were exposed to more ethylene oxide sterilization cycles than approved, which reduces their tensile strength over time. This weakening could cause the sutures to break during surgery, leading to wound dehiscence, excessive bleeding, or other complications.
Surgical professionals and patients who used the recalled lot of Sofsilk Braided Silk sutures (Product S-2782K) with UDI-DI 20884521086422 Lot D2F2101RY. Patients using these sutures in ophthalmic procedures are at higher risk for vision loss.
Check for the product number S-2782K and UDI-DI 20884521086422 Lot D2F2101RY on the packaging or label. The sutures are nonabsorbable, sterile silk threads used for soft tissue repairs.
Look for the product number S-2782K and UDI-DI 20884521086422 Lot D2F2101RY on the packaging or label.
One lot of Sofsilk Braided Silk sutures was exposed to more than the approved number of ethylene oxide sterilization cycles, which may reduce tensile strength over time.
Weakened sutures could cause wound dehiscence, bleeding, infection, or vision loss in ophthalmic procedures.
Check for product number S-2782K and UDI-DI 20884521086422 Lot D2F2101RY on the packaging or label.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1697-2024 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1697-2024 from Covidien. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
