Covidien recalls Sofsilk coated braided silk suture products due to risk of infection or vision loss in eye surgeries if the sterile barrier pouch is breached during patient contact.
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Covidien is recalling Sofsilk coated braided silk suture products because the sterile barrier pouch may breach during use, potentially causing infection or vision loss in eye surgeries. Patients using these sutures for eye procedures should stop using them immediately.
The sterile barrier pouch in these suture products may breach during use, allowing contaminants to enter the surgical site. This can lead to infections or vision loss if the product comes into direct contact with the patient during eye procedures.
Healthcare professionals and patients who use Sofsilk suture products for ophthalmic procedures are at risk. Those with direct patient contact during eye surgery using the recalled products are most vulnerable.
Check for the product codes listed in the recall notice: CS211, CS490, CS562, GS823, GS835, S1172, S1173, S1174, S1750K, S176, S1768K, S182, S183, S184, S185, S187, S206, S243, S244, S245, S246, S2782K, S303, S304, S305, S316, S317, S318, S346, S605, S607, S608, SS523, SS525, SS5641, SS5641G, SS5678, SS5684, SS623, SS645, SS653, SS673, SS683G, SS685G, SS686, SS689, SS745, SS786, SS787, VS533, VS845, VS870, VS871, VS8712, VS872, VS8722, VS882, VS8902, XX5278, XX5280, XX5281, XX5284.
Immediately stop using any Sofsilk suture products with the model numbers listed in the recall notice.
The recall includes Sofsilk coated braided silk suture products with model numbers such as CS211, CS490, CS562, GS823, GS835, S1172, S1173, S1174, S1750K, S176, S1768K, S182, S183, S184, S185, S187, S206, S243, S244, S245, S246, S2782K, S303, S304, S305, S316, S317, S318, S346, S605, S607, S608, SS523, SS525, SS5641, SS5641G, SS5678, SS5684, SS623, SS645, SS653, SS673, SS683G, SS685G, SS686, SS689, SS745, SS786, SS787, VS533, VS845, VS870, VS871, VS8712, VS872, VS8722, VS882, VS8902, XX5278, XX5280, XX5281, and XX5284.
The sterile barrier pouch in these suture products may breach during use, potentially causing infection or vision loss in eye surgeries if the product comes into direct contact with the patient.
Check the model numbers on the product packaging. The recall includes specific model numbers listed in the notice, such as CS211, CS490, and others.
Immediately stop using the product and contact your healthcare provider for guidance on alternative products.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1176-2023 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1176-2023 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.
