Olympus recalls PK Cutting Forceps (model PK-CF0533) due to potential jaw breakage during surgery from defective welding. Affected units sold since 2020.
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 PK Cutting Forceps (model PK-CF0533) because defective welding could cause the surgical tool's jaw to break during use. This poses a risk of injury to patients or surgeons during procedures.
The cutting forceps contain components with defective welding that could break during clinical use. This might cause the tool to malfunction while cutting or coagulating tissues, potentially leading to injury.
Surgeons and medical staff using Olympus PK Cutting Forceps (model PK-CF0533) are affected. Patients undergoing procedures with these tools may be at risk if the jaw breaks during surgery.
Check for the model number PK-CF0533 on the product. These forceps were sold since 2020 and are used in surgical procedures to cut and coagulate tissues.
Look for the model number PK-CF0533 on the forceps or packaging.
Olympus identified that the Cutting Forceps contain components with defective welding that could break during clinical use.
The recall does not specify a remedy, so contact Olympus directly for guidance.
The product may be unsafe due to potential jaw breakage during surgery, so it is recommended to stop using it until further instructions are received.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1640-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1640-2026 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.
