Covidien recalls hemorrhoid and prolapse stapler sets with DST Series Technology 4.8MM due to potential improper welding of the staple guide, which may cause 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 4.8MM (Product Number HEM3348) because the yellow staple guide may weld improperly, leading to bleeding or anastomotic leaks. This recall affects medical devices used in rectal procedures.
The yellow staple guide may weld improperly during manufacturing, causing the staples to form incorrectly. This can lead to bleeding or anastomotic leaks during surgical procedures.
Medical professionals who use the recalled stapler sets for hemorrhoid or rectal prolapse procedures are most at risk. Patients undergoing surgery with these devices could experience bleeding or leaks.
Check for Product Number HEM3348 with GTIN numbers 1-10884521047563 or 2-20884521047560. The device is sold in specific lots: N7K0694MX, N7L1078MX, N7M0837MX.
Verify the product number (HEM3348) and GTIN numbers to confirm if your device is recalled.
The yellow staple guide may weld improperly, leading to incorrect staple formation and potential bleeding or anastomotic leaks during surgery.
Check the product number and GTIN numbers to see if it's recalled; if so, contact the manufacturer for further instructions.
Yes, improper staple formation could cause bleeding or anastomotic leaks during rectal procedures.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1528-2018 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1528-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
