Ethicon recalls 21mm diameter Model SDH21A intraluminal staplers due to potential insufficient firing stroke causing incomplete staple formation. Affected units were sold between February 2023 and March 2024.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Ethicon is recalling straight intraluminal staplers with model SDH21A and 21mm diameter because they may not fire properly to form complete staples. This could lead to improper tissue attachment during medical procedures.
The staplers may not have enough movement to properly break the washer and form complete staples. This could result in tissue not being securely joined during surgical procedures, potentially causing leaks or complications.
Surgical professionals using these staplers for procedures involving tissue anastomosis are most at risk. Patients undergoing surgery with these specific staplers may experience incomplete tissue joining.
Check for the model number SDH21A and 21mm diameter on the stapler. These units were sold between February 2023 and March 2024.
Identify the model number and diameter on the stapler to confirm if it matches the recalled SDH21A 21mm size.
The staplers may have an insufficient firing stroke to break the washer and completely form staples, which could lead to improper tissue joining during surgery.
The recall record does not specify a remedy, so contact Ethicon Endo-Surgery directly for guidance.
These units were sold between February 2023 and March 2024.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-1275-2019 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-1275-2019 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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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.
