Recall of Olympus Everest Bipolar Cutting Forceps Model 3005
Olympus is recalling 106 units of the Everest Bipolar Cutting Forceps due to potential jaw breakage from defective welds in the components.
Recall Article
What Happened
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process, potentially resulting in the jaw breaking during clinical use.
Which Products Are Affected
The affected product is the Olympus Everest Bipolar Cutting Forceps, Model 3005. It includes 106 units with UDI: 00821925035881 and all unexpired lot numbers. The product is distributed nationwide in the US and to countries including Canada, Mexico, EU, Australia, China, Singapore, Korea, and Japan.
What You Should Do
Consumers should contact the recalling firm, Olympus Corporation of the Americas, as the recall was initiated via letter for further instructions on the affected devices.
Why This Matters
This recall affects 106 medical devices that could malfunction during procedures, potentially impacting patient safety in clinical settings.
Source
FDA Recall Number: Z-1638-2026
Source: FDA Official Notice