Everest Bipolar Cutting Forceps Recalled for Potential Sterility Breach
Olympus is recalling Everest Bipolar Cutting Forceps due to fractures and breakages in packaging trays and Tyvek covers that may result in a sterility breach. Approximately 6985 units are affected and were distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall involving potential sterility breach from packaging defects. This qualifies as a risk-of-harm product where injury has not yet been reported. No illnesses or injuries have been reported in the source material.
Plain-English summary
Olympus Corporation of the Americas is recalling Everest Bipolar Cutting Forceps, surgical instruments used in minimally invasive procedures. These devices are designed to pass through 5-mm or 10-mm cannulas and use electrosurgical energy to coagulate and cut tissue. Approximately 6985 units are affected by this recall.
The defect involves fractures and breakages in the packaging trays and Tyvek covers. These packaging defects may result in a sterility breach. For surgical instruments, maintaining sterility before use is a critical safety requirement.
The affected devices were distributed worldwide, including the United States, Canada, Germany, Australia, Singapore, and South Korea. Multiple batch numbers are involved in the recall.
The recalled product
- Product
- The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visualization. The device is to be used with bipolar outputs of…
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 6,985
Distribution
Part of a larger recall action
This product is one of 3 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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