Olympus recalls PKS Cutting Forceps model 920005PK due to potential jaw breaking during clinical use from defective welding. Affected users should contact Olympus for details.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Olympus is recalling PKS Cutting Forceps model 920005PK because defective welding could cause the jaws to break during medical procedures. This poses a risk of injury to patients or healthcare workers if the device fails unexpectedly.
The cutting forceps have defective welds due to inadequate supplier validation of the welding process. This can cause the jaws to break during clinical use, potentially leading to injury or complications in surgery.
Healthcare professionals using the PKS Cutting Forceps for surgical procedures are most at risk. Patients receiving surgery with these devices may also be affected if the forceps break during the procedure.
Check for the model number 920005PK on the device. The PKS Cutting Forceps are intended for use with a 5mm cannula in surgical procedures. They were sold with all unexpired lot numbers.
Reach out to Olympus Corporation of the Americas for specific instructions on how to return or replace the device.
Olympus identified that the Cutting Forceps contain components with defective welds due to inadequate supplier validation of the welding process.
Defective welds can cause the jaws to break during clinical use, potentially leading to injury or complications in surgery.
Look for the model number 920005PK on the device. The PKS Cutting Forceps are intended for use with a 5mm cannula in surgical procedures.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1644-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1644-2026 from Olympus. 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.
