Ethicon recalls ECHELON FLEX Powered Plus Stapler devices labeled as 60mm but containing 45mm devices. This mislabeling may cause surgical errors. Affected units have specific product codes and expiration dates.
Mislabeled: Labeled on the package as 60mm contains 45mm devices
Ethicon is recalling ECHELON FLEX Powered Plus Stapler surgical devices because they are mislabeled as 60mm but actually contain 45mm devices. This could lead to surgical errors if used without proper size awareness.
The devices are labeled as 60mm but contain 45mm devices. This size discrepancy could lead to improper surgical technique if the surgeon uses the device without verifying the actual size, potentially causing tissue damage or surgical errors.
Surgical professionals using the ECHELON FLEX Powered Plus Stapler for procedures like resection or anastomosis. Patients undergoing surgery with this device may be at risk if the mislabeled size causes incorrect application.
Check for product code PSEE60A, lot number U94V47, and expiration date July 31, 2023. The devices are sold under GTIN 10705036014607.
Look for the product code PSEE60A, lot number U94V47, and expiration date July 31, 2023 on the device packaging.
The devices are mislabeled as 60mm but contain 45mm devices, which could lead to surgical errors if the incorrect size is used.
Check the device label for product code PSEE60A, lot number U94V47, and expiration date July 31, 2023. If it matches, contact Ethicon for further instructions.
The recall is for mislabeling, not a safety hazard that causes injury. The risk is low and related to potential surgical errors.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-2326-2021 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-2326-2021 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.
