Olympus endoscopes recalled for potential water contamination in channels
Aizu Olympus Co., Ltd. is recalling duodenovideoscope models due to an unvalidated channel air drying process. Water remaining in the channels after repair poses a potential contamination risk that could lead to 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 with no reported illnesses or infections. The hazard—water contamination in endoscope channels—poses a theoretical risk of infection but no actual infections have been documented. Per the severity rubric, risk-of-harm products without reported injury are scored as High (3).
Plain-English summary
Aizu Olympus Co., Ltd. is recalling specific duodenovideoscope models used for endoscopic and surgical procedures. The affected models are TJF-145, TJF-150, TJF-Q180V, and TJF-Q190V. These instruments and their associated endotherapy accessories, such as biopsy forceps, and other ancillary equipment are used for endoscopy and endoscopic surgery.
The recall was initiated because the manufacturer's channel air drying process was not validated. As a result, a small percentage of scopes returned to customers after repair contained water remaining in their channels. Water in the channels creates a potential for contamination that could lead to the risk of infection.
These endoscopes have been distributed worldwide and nationwide in the United States. Healthcare facilities using these affected models should discontinue use of any instruments found to have wet channels and contact the manufacturer for guidance on proper drying validation and corrective repairs. Practitioners should ensure all channel drying procedures are properly validated before returning equipment to service.
The recalled product
- Product
- Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery Model Numbers: TJF-145, TJF-150, TJF-Q180V, TJF-Q190V.
- Manufacturer
- Aizu Olympus Co., Ltd.
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)
- Model Number (UDI-DI): TJF-145 (04953170339950)
- TJF-150 (04953170307553)
- TJF-Q180V (04953170229503)
- TJF-Q190V (04953170405563).
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 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.
See all 22 products in this recall →Related recalls
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