High FDA (Devices)·Z-1178-2023·Announced 2023-03-08

Surgilon Braided Nylon sutures recalled due to sterile barrier defect

Covidien is recalling Surgilon Braided Nylon sutures due to a sterile barrier breach in the breather pouch that could allow bacterial contamination, potentially causing infection or vision loss in ophthalmic procedures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall involves a manufacturing defect that could compromise sterile barrier integrity in surgical sutures used in vision-critical ophthalmic procedures. The source text does not report any illnesses or injuries, and the hazard is potential rather than confirmed, placing this at the risk-of-harm level with no reported injuries.

Plain-English summary

Covidien, LP is recalling multiple lot numbers of Surgilon Braided Nylon sutures, a sterile surgical suture used in medical procedures. The recall is due to a sterile barrier breach in the breather pouch that may allow microorganisms to enter the package, compromising the sterility of the sutures.

A breach in the sterile barrier can result in bacterial contamination of the sutures. When contaminated sutures are used in ophthalmic procedures (eye surgery) where there is direct patient contact, there is a potential risk of infection or vision loss.

The recalled sutures were distributed nationwide in the United States and to numerous countries worldwide. Approximately 87,708 units were distributed. Multiple product codes and lot numbers are affected, as detailed in FDA's recall notice.

Healthcare facilities and surgeons should stop using the affected sutures immediately and quarantine any remaining inventory. The sutures should not be used in patient procedures. For specific lot numbers and product codes affected, healthcare providers should consult the FDA recall notice or contact Covidien directly for full details.

The recalled product

Product: Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-61 SURGILON* 0 B
Manufacturer: Covidien, LP
Category: Medical Device — Surgical Sutures
Hazard: sterile-barrier-breach
bacterial-contamination
infection
vision-loss
Affected units: 87,708

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (18)

GTIN: 20884521073996
20884521076652
10884521072183
20884521072180
10884521071223
20884521071220
10884521071797
20884521071794
20884521071763
20884521071787
20884521071749
10884521073838
20884521073835
20884521076669
10884521076662
10884521071766
20884521071725
10884521071513

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by Covidien, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

Same manufacturer · Covidien, LP

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