Ultrasonic Gastrovideoscope Recalled Due to Reprocessing Incompatibility and Infection Control Risk
Olympus recalls the GF-UC140P-AL5 ultrasonic gastrovideoscope nationwide because it is no longer compatible with the OER-Pro reprocessing system, creating an infection control risk to patients.
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: This is an FDA Class II recall of a medical device used in patient care. Although no illnesses or injuries have been reported, the incompatibility with the OER-Pro reprocessor prevents proper infection control and device reprocessing, which constitutes a risk-of-harm product where injury has not yet been reported, scoring as High per the severity rubric.
Plain-English summary
Olympus Corporation of the Americas is recalling the GF-UC140P-AL5 Ultrasonic Gastrovideoscope. This device is intended for endoscopic real-time ultrasound imaging.
The recall is being issued because the GF-UC140P-AL5 is no longer compatible with the OER-Pro reprocessing system. Incompatibility with the intended reprocessor prevents proper reprocessing of the device and presents an infection control risk to patients.
All serial numbers of this device are affected. A total of 731 units have been distributed nationwide.
The recalled product
- Product
- Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscope
- Affected units
- 731
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)
- All serial numbers. GTIN: 04953170356322
Distribution
Distributed nationwide across the United States.
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