Ethicon PDS Plus 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 a specific antibacterial suture product because it doesn't meet the required strength standards. This could lead to the suture breaking during medical procedures, potentially causing complications for patients.

Why it’s dangerous

The suture does not meet the required tensile strength specifications, meaning it may break under normal use during medical procedures. This could lead to complications such as incomplete wound closure or tissue damage.

Who’s affected

Medical professionals and patients who have received this specific suture product are affected. The risk is low for most users as the issue is related to product specifications rather than immediate danger.

How to tell if you have this one

Check for the product code PDP493G (GTIN 10705031203945) and lot number MCZ162 on the packaging. This suture is sold under the brand Ethicon.

Brand
Ethicon
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the product code PDP493G (GTIN 10705031203945) and lot number MCZ162 on the packaging.

✎ GovInfoNow

Questions people ask

Is this suture dangerous to use?

The recall states the suture does not meet tensile strength specifications, which could lead to breaking during use. However, the risk is low for most users.

What should I do if I have this suture?

The recall does not specify a remedy, so contact Ethicon directly for guidance on next steps.

How can I tell if I have the recalled product?

Check for product code PDP493G (GTIN 10705031203945) and lot number MCZ162 on the 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-2533-2018 — Ethicon Ethicon

Hello,

I own a Ethicon that is covered by recall Z-2533-2018 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-2533-2018 (June 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2533-2018 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 Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G

Lower-risk recall