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Use caution Medical device recall · FDA · Published August 8, 2022

Ethicon PDS II Suture Recall: Incorrect Material Risk

Ethicon recalls PDS II sutures with possible incorrect material that could impact treatment. Consumers should check product details and contact Ethicon for guidance.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1773-2022Medical deviceEthicon ›
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Contact the company

Recalling firmEthicon, Inc.Us Highway 22 West · Somerville, NJ 08876
✎ GovInfoNow plain-language explainer

Ethicon is recalling PDS II sutures that may contain the wrong material, which could affect medical treatment. This is serious because using incorrect sutures might lead to treatment complications. Read more at govinfonow.com/recall/60206-ethicon-pds-ii-suture-recall-incorrect-material-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/60206-ethicon-pds-ii-suture-recall-incorrect-material-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1773-2022

Cite this page

“Ethicon PDS II Suture Recall: Incorrect Material Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60206-ethicon-pds-ii-suture-recall-incorrect-material-risk. Based on FDA recall #Z-1773-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1773-2022%22&limit=1).

Ethicon, Inc. recalled PDS II sutures on Aug. 8, 2022, because they may contain incorrect material that could impact treatment, the FDA said. The voluntary Class II recall affects products distributed in Japan.

How to tell if you have it

  • Brand: Ethicon
  • Product: PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
  • UDI-DI (GTIN): 10705031061705 (individual unit); 30705031061709 (sales unit box)
  • Product Number: Z771D
  • Lot No: SAMPAL
  • Quantity: 88 boxes (1056 ea)
  • Distribution: Japan only

The hazard

The product may contain the incorrect material which could impact treatment, according to the FDA.

Context

GovInfoNow's records show ETHICON, INC. has 25 other recalls on record since 2017-08-17. Other recent recalls of similar products include Ethicon Monocryl" Sutures Recall (2024-10-08), Ethicon Coated VICRYL Suture Recall (2024-09-25) and Ethicon Monocryl Plus Suture Recall (2024-05-10). Other recent recalls of similar products include ConMed Suture Anchor Recall (2026-07-14), Straumann Custom Abutment AS Ti Recall (2026-03-17) and Covidien Dermalon 4-0 Blue 75cm Sutures Recall (2026-06-24).

How to tell if you have this one

Check for the product code Z771D, 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles. The UDI-DI (GTIN) numbers 10705031061705 (individual) or 30705031061709 (box) help identify the recalled items.

  • Brand
    Ethicon
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the product code Z771D, 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles.

How this recall unfolded

Recall timeline

FDA published this recall 51 days after the firm started it.

1. Firm started the recall: Aug 8, 202212. FDA classified it Class II: Sep 20, 202223. Published in FDA’s Enforcement Report: Sep 28, 202232022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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-1773-2022 (August 8, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1773-2022 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA