The Recall Desk
HighFDA (Devices)·Z-2497-2023·Announced 2023-09-06

Olympus Bronchovideoscope Model BF-MP190F Recall for Oversized Diameter

Olympus Corporation recalls 441 Bronchovideoscope Model BF-MP190F units. The endoscope's diameter is too large, causing it to become lodged in the endotracheal tube connector.

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 an FDA Class II recall with no reported illnesses or injuries. Per the rubric, unresolved hazards without reported harm score at most 3. The mechanical defect poses a potential risk of device lodging in the connector, which could impair airway management.

Plain-English summary

Olympus Corporation of the Americas is recalling the Bronchovideoscope, Model BF-MP190F. The endoscope's outer diameter is too large, causing the device to become lodged when inserted into the endotracheal tube connector. This mechanical fit issue can interfere with the device's proper positioning and removal during medical procedures.

A total of 441 units were distributed nationwide in the United States. The recall affects all serial numbers of this model.

Healthcare facilities and clinicians using this device should stop using Model BF-MP190F immediately and contact Olympus Corporation for instructions regarding replacement or repair of affected units.

The recalled product

Product
Olympus Bronchovideoscope, Models BF-MP190F.
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Endoscopy / Airway Equipment
Hazard
  • device-lodging
  • 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 (2)

  • UDI-DI: 04953170395581
  • All Serial Numbers.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category