Improperly Repaired Gastrointestinal Videoscope May Expose Patients to Contamination
Aizu Olympus gastrointestinal videoscopes (GIF-H190) may have defective repairs that prevent proper sterilization, risking patient exposure to contaminated material. Affected units were distributed to medical facilities in six states.
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 device with potential for serious patient harm through device malfunction and contamination risk, though no illnesses or injuries have been reported. The defect in reprocessing capability creates risk of infection from contaminated material exposure.
Plain-English summary
Aizu Olympus Co., Ltd. is recalling 24 units of the GIF-H190 EVIS EXERA III gastrointestinal videoscope due to improperly repaired light guide connectors. The repair defect involves missing adhesive that fails to secure the suction channel mouthpiece to the scope connector.
This defect can cause loss of image, decreased suction, and prevents the device from being effectively reprocessed and sterilized. These failures may result in unanticipated delays to patient treatment. Additionally, improper reprocessing creates a risk of patient exposure to contaminated material and subsequent infection.
Twenty-four affected devices with serial numbers 2515895, 2312905, and 2628532 were distributed to medical facilities in Florida, Kentucky, Massachusetts, New Jersey, New York, and Pennsylvania.
The recalled product
- Product
- GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
- Manufacturer
- Aizu Olympus Co., Ltd.
- Category
- Medical Device — Endoscope
- 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 (3)
- UDI-DI 04953170305290 Serial Numbers 2515895
- 2312905
- 2628532
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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