Ethicon recalls PROXIMATE HCS Hemorrhoidal Circular Staplers (Product Code PPH01) due to potential bleeding or soft tissue injury from improper assembly. Affected units sold with lot codes P9461W or P94K20.
Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially cause bleeding or soft tissue injury during use as the device may not fully cut when fired
Ethicon is recalling PROXIMATE HCS Hemorrhoidal Circular Staplers (Product Code PPH01) because some units may have been assembled without a washer, which could cause bleeding or soft tissue injury during use. This recall affects patients who have had surgery involving hemorrhoidal tissue repair.
The stapler may not fully cut when fired if assembled without a washer, which can lead to bleeding or soft tissue injury during surgical procedures. This issue occurs because the washer is necessary for proper function and safety.
Patients who have had hemorrhoid surgery using this specific stapler model are most at risk. The recall applies to units sold with lot codes P9461W or P94K20.
Check for the product code PPH01 on the stapler and accessories. Affected units were sold with lot codes P9461W or P94K20.
Look for the product code PPH01 on the stapler and accessories to confirm if it is affected.
The stapler may have been assembled without a washer, which can cause bleeding or soft tissue injury during use as the device may not fully cut when fired.
Check the product code and lot code to see if it is affected. If it is, contact Ethicon for further instructions.
Yes, using an affected unit could cause bleeding or soft tissue injury during surgical procedures.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-0695-2019 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-0695-2019 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.
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.
