Olympus ENDOEYE Videoscope Recalled for Reprocessing Instructions Deviations
Olympus Corporation recalls 1,403 ENDOEYE Flex endoscopic videoscopes due to deviations in reprocessing instructions. Affected devices may not be reprocessed properly for safe reuse in surgical procedures.
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 recall with no reported illnesses or injuries. Incomplete or incorrect reprocessing instructions could lead to inadequate sterilization of surgical instruments, qualifying this as a risk-of-harm product where injury has not yet been reported per the rubric.
Plain-English summary
Olympus Corporation of the Americas is recalling 1,403 ENDOEYE Flex Deflectable Videoscope units (Model LTF-S190-5) distributed nationwide. These videoscopes are used with various equipment for endoscopic and endoscopic surgical procedures in the thoracic cavity, abdominal cavity, and female reproductive organs.
The recall addresses deviations in the Instructions for Use related to reprocessing of the videoscope. Proper reprocessing steps are necessary for the safe use of these devices. The Instructions for Use do not currently contain complete or accurate reprocessing instructions.
Users of affected videoscopes should obtain the correct reprocessing instructions from Olympus Corporation of the Americas and follow them carefully. The affected devices are identified by UDI-DI: 04953170310355, which applies to all serial numbers.
The recalled product
- Product
- OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery…
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 1,403
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-DI: 04953170310355 All Serial Numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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