Lower riskMedical device recall · FDA · Published September 25, 2024
Ethicon Coated VICRYL Suture Recall: Needle Pull-Off and Degradation Risk
Ethicon recalls coated VICRYL Polyglactin 91:0 suture due to needle pull-off and visible degradation in packaging. Affected units may have compromised strength.
Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.
“Ethicon Coated VICRYL Suture Recall: Needle Pull-Off and Degradation Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53860-ethicon-coated-vicryl-suture-recall-needle-pull-off-and-degradation. Based on FDA recall #Z-0319-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0319-2025%22&limit=1).
The FDA announced on September 25, 2024, that Ethicon, Inc. is voluntarily recalling Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT due to needle pull-off and suture degradation hazards. The recall affects 31,032 units distributed internationally to China.
Complaints were received regarding needle pull-off and suture degradation, according to the FDA. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.
Context
GovInfoNow's records show ETHICON, INC. has 25 other recalls on record since August 17, 2017. Other recent recalls of similar products include Ethicon Monocryl Sutures Recall (October 8, 2024), Ethicon PDS Plus Suture Recall (May 10, 2024), and Ethicon SURGIFOAM Absorbable Gelatin Powder Kit Recall (April 23, 2024). Other recent recalls of similar products include Covidien Dermalon 4-0 Blue 75cm Sutures Recall (June 24, 2026), Covidien V-Loc 180 Absorbable Wound Closure Device Recall (June 24, 2026), and Covidien V-Loc 90 Wound Closure Device Recall (June 24, 2026).
How to tell if you have this one
Check for the product number J358H on the packaging. The lot number QP2AJM and UDI-DI 10705031237308 (each) or 30705031237302 (box) indicate the affected units.
Brand
Ethicon
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Packaging
Look for the product number J358H, lot number QP2AJM, and UDI-DI numbers on the packaging.
How this recall unfolded
Recall timeline
FDA published this recall 49 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The recall indicates some sutures may have degraded in packaging, potentially causing needle pull-off and weakening during use. This could affect surgical outcomes.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0319-2025 (September 25, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0319-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.