Agency classClass IIOur severity:High FDA (Devices)·Z-2144-2024·Announced 2024-06-26

VICRYL Sutures recalled due to packaging defect compromising sterility

Ethicon recalls 341,532 units of VICRYL surgical sutures worldwide due to holes in primary packaging that compromise 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: FDA Class II recall with no reported illnesses or injuries. The hazard is real—compromised sterility in surgical sutures could cause infection—but is currently theoretical. Per the rubric, risk-of-harm medical devices without reported harm score at 3 (High).

Plain-English summary

Ethicon, Inc. is recalling VICRYL (polyglactin 910) sutures, surgical devices indicated for use in general soft tissue approximation and ligation, including ophthalmic surgery. The recall affects 341,532 units distributed worldwide, including throughout the United States and Puerto Rico.

The recall was initiated because a packaging machine defect resulted in holes in the primary packaging of affected units. This defect compromises the sterility of the product, which is critical for surgical sutures.

A compromised sterile barrier could result in infection if the affected sutures are used in surgical procedures. Healthcare facilities and surgical teams should immediately discontinue use of the affected product codes and lot numbers and quarantine remaining inventory. Affected product codes and lot numbers are detailed in the FDA recall notice.

The recalled product

Product: VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues. PRODUCT CODE: J214H J218H J258H J268H J269H J327H…
Manufacturer: Ethicon, Inc.
Category: Medical Device — Surgical Sutures
Hazard: packaging-defect
sterility-compromise
infection-risk
Affected units: 341,532

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

Same hazard · packaging defect