The Recall Desk
HighFDA (Devices)·Z-0319-2025·Announced 2024-11-13

Coated VICRYL Surgical Sutures Recalled for Needle Pull-Off and Degradation

Ethicon is recalling Coated VICRYL surgical sutures due to needle pull-off and visual degradation. Lot QP2AJM, consisting of 31,032 units, was distributed to China.

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: FDA Class II medical device with confirmed product defects (needle pull-off and visual suture degradation) affecting surgical sutures. No reported patient injuries or deaths are mentioned in the source, but the hazard represents a risk of product failure during surgical use.

Plain-English summary

Ethicon, Inc. is recalling Coated VICRYL Polyglactin 910 Suture (Product Number J358H) due to reports of needle pull-off and suture degradation. Analysis of returned product from lot QP2AJM confirmed that some sutures showed visual degradation in the package.

The defects reported include needle pull-off and visual suture degradation detected in the product packaging. These issues were confirmed through analysis of returned product samples from the affected lot.

The recalled lot, QP2AJM, consisted of 31,032 units and was distributed internationally to China.

The recalled product

Product
Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
Manufacturer
Ethicon, Inc.
Category
Medical Device — Surgical Suture
Hazard
  • needle-pull-off
  • suture-degradation

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 (3)

  • UDI-DI: 10705031237308 (each)
  • 30705031237302 (box)
  • Lot Number: QP2AJM

Distribution

Distribution scope not specified by the agency.

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