The Recall Desk
HighFDA (Devices)·Z-2495-2023·Announced 2023-09-06

Olympus Airway Mobilescope models may become lodged in connectors

Olympus Airway Mobilescope endoscopes may become lodged in endotracheal tube connectors due to oversized diameter affecting airway management procedures nationwide.

What this means for you

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 with a confirmed mechanical defect creating a risk of device lodgement during airway procedures. No injuries or illnesses have been reported.

Plain-English summary

Olympus Corporation of the Americas is recalling 1,859 units of the Olympus Airway Mobilescope, Models MAF-GM and MAF-TM (UDI-DI: 04953170340369, 04953170288661, and 04953170288630, all serial numbers). The devices are distributed nationwide in the United States.

The recall addresses a complaint that the endoscope model can become lodged in the endotracheal tube connector due to the endoscope's diameter being too large. This mechanical defect may impair proper device function.

Patients who have used this device and healthcare providers should contact Olympus Corporation of the Americas for instructions on return, replacement, or other appropriate remedial measures.

The recalled product

Product
Olympus Airway Mobilescope, Models MAF-GM & MAF-TM.
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Airway Management
Hazard
  • device-lodgement
  • mechanical-defect

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: 04953170340369
  • 04953170288661
  • & 04953170288630
  • All Serial Numbers.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category