Ethicon Straight Intraluminal Staplers: Risk of Incomplete Staple Formation

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Recalling firmEthicon Endo-Surgery Inc4545 Creek Rd · Blue Ash, OH 45242-2803

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Ethicon recalls Straight Intraluminal Staplers (Model SDH25A) because they may not form staples properly. This could lead to tissue damage during medical procedures. Affected units were sold between February 2023 and March 2024.

Why it’s dangerous

The staplers may not form staples completely due to an insufficient firing stroke. This could cause tissue damage or improper closure during surgery. The issue affects the device's ability to create secure tissue attachments.

Who’s affected

Medical professionals using the staplers for surgical procedures are most at risk. Patients undergoing surgery with these staplers may experience complications.

How to tell if you have this one

Check for the model number SDH25A on the stapler. Affected units were sold between February 2023 and March 2024.

Brand
Ethicon
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the model number SDH25A on the stapler to confirm if it is affected.

✎ GovInfoNow

Questions people ask

What is the model number of the affected staplers?

The affected model is SDH25A.

When were these staplers sold?

These staplers were sold between February 2023 and March 2024.

What should I do if I have this model?

Contact Ethicon for details on next steps.

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-1276-2019 — Ethicon Ethicon

Hello,

I own a Ethicon that is covered by recall Z-1276-2019 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-1276-2019 (April 11, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1276-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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 Endo-Surgery Inc recalls Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are

Lower-risk recall