Mobile Airway Scope Recalled Due to Unvalidated Drying Process
Aizu Olympus has recalled 33 Mobile Airway Scope units due to an unvalidated air drying process. Some repaired units had wet channels, creating a potential risk of contamination and 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 a Class II medical device recall involving 33 units with an unvalidated air drying process. No illnesses or infections have been reported, but residual water in endoscope channels creates a theoretical risk of contamination and infection during medical procedures, meeting the rubric criterion for high-severity risk-of-harm products without reported injury.
Plain-English summary
Aizu Olympus Co., Ltd. is recalling 33 Mobile Airway Scope units (models MAF-DM2, MAF-GM, MAF-GM2, MAF-TM, and MAF-TM2) distributed nationwide in the United States. These medical devices are endoscopes used for airway diagnosis, observation, and intubation management.
The recall was initiated because the air drying process for the device's channels was not properly validated. Some scopes returned to customers after repair contained residual water in their channels. Water remaining in the channels creates potential for contamination that could lead to the risk of infection during medical procedures.
Healthcare facilities and medical professionals using these devices should cease use immediately and contact Aizu Olympus Co., Ltd. for instructions on replacement or repair. The FDA classified this as a Class II recall.
The recalled product
- Product
- Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: MAF-DM2, MAF-GM, MAF-GM2, MAF-TM, MAF-TM2.
- Manufacturer
- Aizu Olympus Co., Ltd.
- Hazard
- Affected units
- 33
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 (5)
- Model Numbers: MAF-DM2 (04953170407260)
- MAF-GM (04953170340369)
- MAF-GM2 (04953170407208)
- MAF-TM (04953170288630)
- MAF-TM2 (04953170407147).
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.
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