Ethicon PDS II Suture Recall: Tensile Strength Issue

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Contact the company & request your remedy

Recalling firmEthicon, Inc.Us Highway 22 West, N/A · Somerville, NJ 08876

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Ethicon is recalling certain PDS II sutures because they don't meet the required tensile strength. This could lead to the suture breaking during surgery, potentially causing complications for patients.

Why it’s dangerous

The sutures may break under tension during medical procedures due to insufficient tensile strength. This could lead to complications like tissue damage or incomplete wound closure.

Who’s affected

Surgical professionals and patients who used the recalled sutures during procedures. Those most at risk are individuals who have the specific model and lot numbers listed.

How to tell if you have this one

Check for the product code Z511G (GTIN 10705031061347) and lot number MCZ363 on the suture packaging. The suture is a 45cm (18") 5-0 single armed PS-6 Prime Needle.

Brand
Ethicon
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for product code Z511G (GTIN 10705031061347) and lot number MCZ363 on the suture packaging.

✎ GovInfoNow

Questions people ask

Why is this suture being recalled?

The sutures do not meet the required tensile strength specification, which could lead to breaking during medical procedures.

What should I do if I have this suture?

The recall record does not specify a remedy, so contact Ethicon directly for guidance.

How can I tell if I have the recalled product?

Check for product code Z511G (GTIN 10705031061347) and lot number MCZ363 on the suture packaging.

Take action

Contact Ethicon

We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2534-2018 — Ethicon Ethicon

Hello,

I own a Ethicon that is covered by recall Z-2534-2018 from Ethicon.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-2534-2018 (June 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2534-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 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.

Ethicon, Inc. recalls PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle Product Code:

Lower-risk recall