Ethicon recalls ECHELON 45mm staple reloads with GST technology due to risk of incomplete tissue stitching during surgery, potentially requiring additional procedures. Affected units include specific product numbers and lots.
There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, or surgical delay.
Ethicon recalls certain ECHELON 45mm staple reloads that may not form proper tissue stitches during surgery, risking bleeding or longer procedures. This is a serious issue for surgical procedures using these staples.
The staples may not form a complete stitch line during surgery, causing tissue to not bond properly. This could lead to bleeding, longer surgical times, or the need for additional procedures to fix the issue.
Surgical teams using the ECHELON Endopath Stapler system with the recalled reloads are most at risk. Patients undergoing procedures with these staples may face complications like bleeding or extended surgery.
Check for product numbers GST45W and UDI-DI 10705036014928 on the reloads. The affected lots are 442C02 and 442C03.
Verify the product number (GST45W) and UDI-DI code (10705036014928) on the reloads.
Reach out to Ethicon Endo-Surgery for guidance on next steps if you have the recalled product.
The recall is due to a risk of incomplete staple line formation during surgery, which could lead to bleeding or longer procedures.
Check the product number and UDI-DI code on the reloads; contact Ethicon Endo-Surgery for further instructions.
Yes, patients undergoing surgery with these staples may face bleeding, longer procedures, or additional surgeries.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-0834-2024 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-0834-2024 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.
