Lower risk Medical device recall · FDA · Published January 25, 2024

Covidien Sofsilk Braided Silk Sutures Recall: Risk of Suture Failure After Sterilization

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1697-2024Medical device Covidien ›

Lower-risk 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.

Take action

Contact the company

Recalling firmCovidien, LP60 Middletown Ave · North Haven, CT 06473-3908

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/56256-covidien-sofsilk-braided-silk-sutures-recall-risk-of-suture-failure.

Source Summary by GovInfoNow · govinfonow.com/recall/56256-covidien-sofsilk-braided-silk-sutures-recall-risk-of-suture-failure · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1697-2024

Cite this page

“Covidien Sofsilk Braided Silk Sutures Recall: Risk of Suture Failure After Sterilization.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56256-covidien-sofsilk-braided-silk-sutures-recall-risk-of-suture-failure. Based on FDA recall #Z-1697-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1697-2024%22&limit=1).

The FDA announced on Jan. 25, 2024, that Covidien, LP is recalling Sofsilk Braided Silk sutures because one lot was exposed to excessive Ethylene Oxide sterilization cycles. This may decrease tensile strength and cause wound dehiscence or bleeding.

How to tell if you have it

Brand: Covidien
Product: Sofsilk Braided Silk sutures, Product Number S-2782K
Lot code: D2F2101RY
UDI-DI: 20884521086422

The hazard

One lot of the product was exposed to more than the approved number of Ethylene Oxide 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.

Context

GovInfoNow's records show Covidien, LP has 26 other recalls on record since July 17, 2017. Other recent recalls of similar products include DeRoyal Covaderm Plus Dressing Recall (May 18, 2026), Medline Surgical Drapes Recall (Jan. 7, 2026), and Zimmer Sterile Tourniquet Hoses Recall (June 9, 2026).

How to tell if you have this one

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.

Brand
Covidien
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Suture Packaging
Look for the product number S-2782K and UDI-DI 20884521086422 Lot D2F2101RY on the packaging or label.

How this recall unfolded

Recall timeline

FDA published this recall 3 months after the firm started it.

Jan 25, 2024Firm started the recall
Apr 29, 2024FDA classified it Class II
May 8, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/56256-covidien-sofsilk-braided-silk-sutures-recall-risk-of-suture-failure">Covidien Sofsilk Braided Silk Sutures Recall: Risk of Suture Failure After Sterilization (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-1697-2024 (January 25, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1697-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.