Ethicon STRATAFIX Spiral PDS Plus Violet 18 Suture Recall: Strength Testing Issue

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

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Ethicon is recalling STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle sutures that failed internal strength testing. This could lead to the suture breaking during use, potentially causing injury or complications in medical procedures.

Why it’s dangerous

The suture does not meet internal strength testing specifications, meaning it may break during use. This could cause complications or injury during medical procedures if the suture fails unexpectedly.

Who’s affected

Medical professionals and patients using the recalled suture for surgeries are affected. Those with the specific product code SXPP1B430 and lot number LPH946 are most at risk.

How to tell if you have this one

Check for product code SXPP1B430 and lot number LPH946 on the suture packaging. The suture is violet in color and 45cm long with a CT-1 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 SXPP1B430 and lot number LPH946 on the suture packaging.

✎ GovInfoNow

Questions people ask

Is this suture safe to use?

The recall states the product does not meet internal strength testing specifications, so it is not safe to use.

What should I do if I have this suture?

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

How can I tell if I have the recalled suture?

Check for product code SXPP1B430 and lot number LPH946 on the packaging. The suture is violet, 45cm long, and has a CT-1 needle.

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-0047-2020 — Ethicon Ethicon

Hello,

I own a Ethicon that is covered by recall Z-0047-2020 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-0047-2020 (August 13, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0047-2020 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.

Ethicon, Inc. recalls STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture

Recall notice