Stop using nowMedical device recall · FDA · Published November 16, 2022
Ethicon PDS II Suture Recall: Knots May Break During Surgery
Ethicon recalls violet monofilament PDS II sutures with low knot strength that could break during surgery. Affected units have product code Z340H and expire February 2027. Stop using immediately.
knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative breakage
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Contact the company
📍Recalling firmEthicon, Inc.Us Highway 22 West · Somerville, NJ 08876
“Ethicon PDS II Suture Recall: Knots May Break During Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59371-ethicon-pds-ii-suture-recall-knots-may-break-during-surgery. Based on FDA recall #Z-0480-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0480-2023%22&limit=1).
Ethicon, Inc. recalled PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 on November 16, 2022, according to the FDA. The hazard is that knot tensile strengths were significantly below minimums, resulting in breakage prior to use or intra-operatively.
The recall involves PDS II sutures where knot tensile strengths were observed to be significantly below the minimum knot tensile. This defect will result in breakage prior to use or intra-operatively rather than premature post-operative breakage.
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 Coated VICRYL Suture Recall (September 25, 2024), and Ethicon PDS Plus Suture Recall (May 10, 2024). Other recent recalls of similar products include da Vinci S/Si Cautery Hook Recall (December 9, 2025), da Vinci S Si Tenaculum Forceps (December 9, 2025), and Genesis Push-In Suture Anchor Recall (December 17, 2025).
How to tell if you have this one
Check for the product code Z340H on the suture packaging. The suture is violet in color, 27 inches long, and labeled for soft tissue use. It expires February 2027.
Brand
Ethicon
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop Using Immediately
Discard the suture if you have it, as it may break during surgery.
How this recall unfolded
Recall timeline
FDA published this recall 35 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 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-0480-2023 (November 16, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0480-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.