Agency classClass IIOur severity:High FDA (Devices)·Z-2148-2024·Announced 2024-06-26

MONOCRYL Surgical Sutures Recalled for Packaging Sterility Defect

Ethicon recalls 306,000 MONOCRYL surgical sutures worldwide due to holes in primary packaging from a manufacturing defect that compromises sterility and could result in infection.

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: This FDA Class II medical device recall presents significant infection risk due to packaging defects compromising sterility. No illnesses or injuries have been reported; the hazard is high-consequence but theoretical, meeting the rubric criterion for score 3.

Plain-English summary

Ethicon, Inc. is recalling approximately 306,000 units of MONOCRYL (poliglecaprone 25) Suture, a medical device used for general soft tissue approximation and ligation in surgical procedures.

The recall was initiated due to an issue with a specific packaging machine that resulted in holes in the primary packaging. This defect compromised product sterility, creating a potential risk of infection if the product is used.

The affected sutures were distributed worldwide, including throughout the United States, Puerto Rico, and to Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, Israel, Japan, Kuwait, Mexico, New Zealand, Panama, Saudi Arabia, Singapore, Uruguay, and South Africa.

Healthcare providers and consumers who have these sutures should discontinue use and contact Ethicon, Inc. for further instructions regarding the affected lot numbers.

The recalled product

Product: MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y398H Y416H Y417H Y426H Y427H Y935H Y936H Y945H
Manufacturer: Ethicon, Inc.
Category: Medical Device — Surgical Sutures
Hazard: infection
sterility-compromise
packaging-defect
Affected units: 306,000

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Part of a larger recall action

This product is one of 6 recalled by Ethicon, Inc. 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 6 products in this recall →

Same manufacturer · Ethicon, Inc.

See all →

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FDA (Devices) · 2024-11-27
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Coated VICRYL Surgical Sutures Recalled for Needle Pull-Off and Degradation
FDA (Devices) · 2024-11-13
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PDS Plus Antibacterial Surgical Sutures Recalled for Compromised Sterility
FDA (Devices) · 2024-06-26
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PDS II Polydioxanone Sutures Recalled Due to Compromised Sterility
FDA (Devices) · 2024-06-26
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Ethicon MONOCRYL Plus Sutures Recalled for Packaging Defect
FDA (Devices) · 2024-06-26

Same hazard · infection