Agency classClass IIOur severity:High FDA (Devices)·Z-1174-2023·Announced 2023-03-08

Monosof nylon sutures recalled for sterile barrier breach

Covidien is recalling Monosof nylon sutures due to sterile barrier breach in the breather pouch, which may cause infection or vision loss in ophthalmic procedures. The recall affects 54,288 units distributed nationwide and globally.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: FDA Class II recall involving a direct contamination risk to sterile surgical products. The sterile barrier breach presents a significant potential for patient harm (infection or vision loss) in ophthalmic procedures. The source describes potential hazards rather than confirmed illnesses, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Covidien, LP is recalling Monosof monofilament nylon sutures in multiple product configurations due to a sterile barrier breach of the breather pouch. The breach may allow contamination that could cause infection or vision loss when the sutures are used in ophthalmic (eye) procedures involving direct patient contact.

The recall affects 54,288 units of various Monosof suture products distributed nationwide in the United States and internationally to numerous countries. Multiple product codes and lot numbers are affected as specified in the FDA recall notice.

This is an FDA Class II medical device recall.

The recalled product

Product: Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36 CN-791-12 MONOSOF* 2-0 BLK 100CM GCC90 CN-793 MONOSOF* 1 BLK 100CM GCC90 X36 CN-793-12…
Manufacturer: Covidien, LP
Category: Medical Device — Surgical Sutures
Hazard: sterile-barrier-breach
infection-risk
vision-loss
Affected units: 54,288

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 (20)

GTIN: 20884521075105
20884521075235
10884521075238
20884521075143
10884521635395
20884521077857
20884521075372
20884521078090
20884521077994
20884521079073
10884521080348
20884521080345
20884521080321
10884521080324
10884521078758
20884521078755
20884521078182
20884521078045
20884521075129
10884521635371

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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Same hazard · sterile barrier breach