Covidien recalls hemorrhoid and prolapse stapler sets with DST Series Technology 3.5MM for potential improper staple formation causing bleeding or anastomotic leaks.
There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding or anastomotic leak.
Covidien is recalling hemorrhoid and prolapse stapler sets with DST Series Technology 3.5MM (product number HEM3335) due to a risk of improper staple formation that could lead to bleeding or anastomotic leaks. This recall affects medical professionals using these devices during surgical procedures.
The staple guide may weld improperly to the instrument, causing staples to form incorrectly. This can lead to bleeding or anastomotic leaks during surgery, which are serious complications that could affect patient outcomes.
Medical professionals who use the recalled hemorrhoid and prolapse stapler sets during surgical procedures are most at risk. The recall specifically targets surgeons and healthcare providers performing rectal procedures.
Check for the product number HEM3335 on the packaging or device. The recall includes specific lots listed in the record: N7J1145MX, N7L0380MX, N7L0762MX, and other lots starting with N7 or N8.
Look for the lot numbers N7J1145MX, N7L0380MX, N7L0762MX, or other listed lots on the packaging or device to confirm if it is affected.
The recalled model is the EEA Hemorrhoid and Prolapse Stapler Set with DST Series Technology 3.5MM (product number HEM3335).
There is a potential for improper welding of the yellow staple guide to the instrument, which could cause improper staple formation and lead to bleeding or anastomotic leaks during surgery.
Check the product number on the packaging or device. The affected units have the product number HEM3335 and specific lot numbers listed in the recall notice.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1527-2018 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1527-2018 from Covidien. 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.
