Agency classClass IIOur severity:High FDA (Devices)·Z-2145-2024·Announced 2024-06-26

FDA Recalls VICRYL Plus Antibacterial Sutures Due to Packaging Defect

Ethicon is recalling VICRYL Plus Antibacterial Sutures due to a packaging machine defect that created holes in the primary packaging, potentially compromising product sterility. Affected sutures may pose an infection risk.

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 of medical sutures with compromised sterility due to packaging defect. The hazard (infection risk) is potential rather than reported, meeting the criterion for High severity: a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Ethicon, Inc. is recalling VICRYL Plus Antibacterial (polyglactin 910) Sutures due to a defect on a specific packaging machine that resulted in holes in the primary packaging. The compromised packaging could allow the sterile product to become contaminated, potentially exposing patients to infection.

The recall affects approximately 55,296 units that were distributed worldwide, including throughout the United States, Puerto Rico, and in 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. Affected product codes are VCP196H, VCP417H, VCP602H, VCP603H, VCP662H, VCPB259H, and VCPB946H, with specific lot numbers identified by the FDA.

The recalled product

Product: VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues. PRODUCT CODE: VCP196H VCP417H VCP602H VCP603H VCP662H VCPB259H…
Manufacturer: Ethicon, Inc.
Category: Medical Device — Surgical Sutures
Hazard: packaging-defect
sterility-compromise
infection-risk
Affected units: 55,296

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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PDS Plus Antibacterial Surgical Sutures Recalled for Compromised Sterility
FDA (Devices) · 2024-06-26
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MONOCRYL Surgical Sutures Recalled for Packaging Sterility Defect
FDA (Devices) · 2024-06-26

Same hazard · packaging defect