Olympus Everest Bipolar Cutting Forceps Recalled for Packaging Defects
Olympus is recalling Everest Bipolar Cutting Forceps surgical instruments due to fractures and breakages in packaging trays and Tyvek covers that may compromise sterility. Affected batches: FR150448, FR154445, FR173022.
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 with potential for sterility compromise—a risk-of-harm product where injury has not yet been reported. The source text explicitly indicates no reported illnesses or injuries, making this a theoretical hazard scenario.
Plain-English summary
Olympus Corporation of the Americas is recalling the Everest Bipolar Cutting Forceps, surgical instruments used for tissue coagulation and cutting in medical procedures. The recall affects 100 units distributed worldwide, including the United States, Canada, Germany, Australia, Singapore, and South Korea.
The forceps are being recalled due to fractures and breakages identified in the packaging trays and Tyvek covers. These defects may result in a breach of sterility, compromising the integrity of the sterile product before use.
Healthcare facilities and practitioners who received affected units from batches FR150448, FR154445, or FR173022 should stop using the products and contact Olympus for further instructions. Users should verify batch numbers before use or dispensing these devices.
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
- 100
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: N/A Batch Numbers: FR150448 FR154445 FR173022
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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