Gastrointestinal Videoscope Recall Due to Improper Repair and Infection Risk
Aizu Olympus recalls 24 gastrointestinal videoscopes with improperly repaired light guide connectors. The defect may cause loss of image and suction, preventing proper device reprocessing and risking patient infection.
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 imaging device with a manufacturing defect that poses a risk of serious harm including patient infection and treatment delay from contamination exposure, though no illnesses have been reported to date.
Plain-English summary
Aizu Olympus Co., Ltd. is recalling 24 units of the GIF-HQ190 EVIS EXERA III Gastrointestinal Videoscope due to improperly repaired light guide connectors. The suction channel mouthpiece was not adequately secured to the scope connector due to missing adhesive during repair.
The defect may result in loss of image, decreased suction capability, and inability to properly reprocess the device. These issues can lead to unanticipated delays in patient treatment and potential exposure to contaminated material, raising the risk of patient infection.
The affected units were distributed domestically to medical facilities in Florida, Kentucky, Massachusetts, New Jersey, New York, and Pennsylvania. The recalled devices are identified by specific serial numbers: 2270393, 2201027, 2201611, and 2745407.
The recalled product
- Product
- GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
- Manufacturer
- Aizu Olympus Co., Ltd.
- Affected units
- 24
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 (4)
- UDI-DI 04953170305276 Serial Numbers 2270393
- 2201027
- 2201611
- 2745407
Distribution
Part of a larger recall action
This product is one of 5 recalled by Aizu Olympus Co., Ltd. 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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