CanadaOlympus Medical PK/PKS/Everest 5 mm cutting forceps — including PKS Cutting Forceps (model 920005PK), Everest Bipolar 5 mm Cutting Forceps (model 3005), PK Cutting Forceps 5 mm (model PK-CF0533) and HALO PKS Cutting Forceps (model HACF0533) — are affected; lot/serial numbers have more than 10 digits, contact the manufacturer for specific serials. Olympus identified inadequate supplier welding validation that may cause jaw breakage during clinical use. Olympus is requesting customers to return all affected products and to contact the manufacturer for additional information.
What's being recalled
Companies: Olympus Medical Systems Corp., 2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507.
How to identify it
Affected products: PKS™ Cutting Forceps; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 920005PK
Affected products: Everest Bipolar 5 mm Cutting Forceps; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 3005
Affected products: PK® Cutting Forceps 5 mm; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: PK-CF0533
Affected products: HALO™ PKS™ Cutting Forceps; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: HACF0533
The hazard
Olympus identified inadequate supplier welding validation on several 5 mm cutting forceps models, which may cause jaw breakage during clinical use. Due to this defect, Olympus is requesting customers to return all affected products to prevent potential safety risks and ensure proper device performance.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)