Ethicon Straight Intraluminal Staplers May Not Form Staples Properly

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

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

✎ GovInfoNow plain-language explainer

What happened, in plain English

Ethicon is recalling straight intraluminal staplers with model SDH33A and 33mm diameter because they may not form staples properly. This could lead to improper tissue attachment during medical procedures.

Why it’s dangerous

The staplers may have an insufficient firing stroke to break the washer and completely form staples. This could result in improper tissue attachment during surgical procedures, potentially leading to leaks or complications.

Who’s affected

Surgical professionals using these staplers for procedures involving tissue attachment. Patients undergoing surgery with these devices are at risk of incomplete tissue sealing.

How to tell if you have this one

Check for the model number SDH33A and 33mm diameter 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 SDH33A and 33mm diameter on the stapler.

✎ GovInfoNow

Questions people ask

Why is this stapler being recalled?

The staplers may have an insufficient firing stroke to break the washer and completely form staples, which could lead to improper tissue attachment during surgery.

When were these staplers sold?

These staplers were sold between February 2023 and March 2024.

What should I do if I have this stapler?

The recall record does not specify a remedy, so check with Ethicon Endo-Surgery Inc for further instructions.

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-1278-2019 — Ethicon Ethicon

Hello,

I own a Ethicon that is covered by recall Z-1278-2019 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-1278-2019 (April 11, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1278-2019 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, 33 mm diameter, Model SDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are

Lower-risk recall