FDA Recall of Olympus PK Cutting Forceps Due to Welding Defect
Olympus is recalling 444 units of its PK Cutting Forceps because of potential welding issues that could cause the jaw to break during clinical use, affecting devices distributed nationwide in the US and internationally.
Recall Article: Olympus PK Cutting Forceps
What Happened
Olympus Corporation of the Americas is recalling the PK Cutting Forceps due to components with inadequately validated welding processes, which could result in defective welds and the jaw breaking during clinical use.
Which Products Are Affected
The affected product is the Olympus PK Cutting Forceps, with Model/Catalog Number: PK-CF0533. The UDI is 00821925035867, and it includes all unexpired lot numbers. A total of 444 units are involved, distributed nationwide in the US and to countries including Canada, Mexico, EU, Australia, China, Singapore, Korea, and Japan. The recall number is Z-1640-2026.
What You Should Do
Consumers and healthcare providers should stop using the affected Cutting Forceps immediately and contact Olympus Corporation of the Americas for instructions on returns or refunds, as the initial notification was made via letter.
Why This Matters
This recall highlights potential risks in medical devices that could lead to malfunctions during procedures, affecting 444 units worldwide and underscoring the need for validated manufacturing processes to ensure patient safety.
Source
This information is attributed to the FDA. For details, refer to the FDA recall page for Recall Number Z-1640-2026.
Source: FDA Official Notice