Olympus Airway Mobilescope Recall Due to Connector Lodging Defect
Olympus is recalling 122 Airway Mobilescope units nationwide because the endoscope can become lodged in endotracheal tube connectors due to oversized diameter. Healthcare providers should immediately stop using affected devices.
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 FDA Class II recall involves a mechanical defect in a medical airway device where the endoscope can become lodged. The absence of injury reports in the source text and Class II designation indicate a significant risk-of-harm without documented patient harm, supporting a High severity classification.
Plain-English summary
Olympus Corporation of the Americas is recalling 122 Airway Mobilescope devices (Models MAF-DM2, MAF-GM2, and MAF-TM2) that were distributed nationwide in the United States. These are medical endoscopes used in airway procedures.
The recall was initiated because the endoscope can become lodged in endotracheal tube connectors due to the device having a diameter that is larger than specified. This mechanical defect can occur during clinical use and may interfere with patient care procedures.
Healthcare facilities and clinicians using these devices should immediately stop using all affected units. Contact Olympus Corporation of the Americas for instructions on device return or replacement. This recall applies to all serial numbers of the three affected models.
The recalled product
- Product
- Olympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2.
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 122
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: 04953170407260
- 04953170407208
- and 04953170407147
- All Serial Numbers.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 recalled by Olympus Corporation of the Americas 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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