Ethicon recalls specific endoscopic staplers due to potential failure to form staples properly. Affected models may not break the washer correctly during use, risking incomplete tissue sealing.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Ethicon is recalling endoscopic curved intraluminal staplers with model ECS21A and 21 mm diameter. The issue could cause staples to not form properly, potentially leading to tissue leaks or infections during surgery.
The staplers may not have enough force to break the washer, which is necessary for forming complete staples. This could result in tissue leaks or infections if the staples don't seal properly during surgery.
Surgical teams using the specific model ECS21A with 21 mm diameter are affected. Patients undergoing procedures with this stapler may face incomplete tissue sealing.
Check for the model ECS21A and 21 mm diameter on the stapler. These were sold between February 2023 and March 2024.
Identify the model number and diameter on the stapler to confirm if it matches the recalled ECS21A (21 mm diameter).
The staplers may have an insufficient firing stroke to break the washer and completely form staples, which could lead to incomplete tissue sealing during surgery.
The recall does not specify a remedy, so contact Ethicon directly for guidance on next steps.
These staplers 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-1271-2019 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-1271-2019 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.