Covidien recalls 5mm Endo Grasp Auto Suture Graspers with inconsistent sterilization. This may affect safety during medical procedures. Check lot numbers P8D1335PRX, P8D1336PR:1605PRX for affected units.
Sterilization method used was not consistent with the labeling and the approved sterilization method
Covidien is recalling 5mm Endo Grasp Auto Suture Graspers due to inconsistent sterilization methods. This could lead to safety issues during medical procedures if the instruments are not properly sterilized.
The sterilization method used does not match the labeling or approved process. This inconsistency could lead to improper sterilization, potentially causing infections or other complications during medical procedures.
Healthcare professionals using these instruments in gynecologic, urologic, thoracic, or endoscopic procedures. Patients undergoing surgeries with these instruments may be at risk if sterilization is inconsistent.
Check for lot numbers P8D1335PRX, P8D1336PRX, and P8D1605PRX on the instrument packaging. These are the specific lot numbers for the recalled 5mm Endo Grasp Auto Suture Graspers.
Look for lot numbers P8D1335PRX, P8D1336PRX, or P8D1605PRX on the instrument packaging.
The recalled instrument is the Covidien Endo Grasp Auto Suture Grasper 5mm with lot numbers P8D1335PRX, P8D1336PRX, and P8D1605PRX.
The sterilization method used does not match the labeling or approved process, which could lead to improper sterilization and potential safety issues during medical procedures.
Check the lot numbers on the packaging. If it matches P8D1335PRX, P8D1336PRX, or P8D1605PRX, contact Covidien for further instructions.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1212-2019 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1212-2019 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.
