The Recall Desk
HighFDA (Devices)·Z-2498-2023·Announced 2023-09-06

Olympus Bronchovideoscope Recalled Due to Lodging Risk in Airway

Olympus is recalling Bronchovideoscope Model BF-XT190 units because the device diameter is too large, causing the endoscope to become lodged in endotracheal tube connectors.

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: FDA Class II recall for a design defect that causes device lodging in a critical airway component. Although no injuries or hospitalizations are reported, the inherent risk of airway obstruction from a lodged endoscope during medical procedures qualifies this as a high-risk product where harm has not yet been reported.

Plain-English summary

Olympus Corporation of the Americas is recalling Bronchovideoscope Model BF-XT190 units distributed throughout the United States. The endoscope can become lodged in the endotracheal tube connector because the device diameter is too large.

Approximately 235 units were affected. The recalled equipment is identified by UDI-DI 04953170402470, and all serial numbers are included in this recall.

Healthcare facilities and medical professionals should immediately discontinue use of the affected Bronchovideoscope units. Contact Olympus Corporation of the Americas for information regarding replacement, repair, or return of the recalled devices.

The recalled product

Product
Olympus Bronchovideoscope, Models BF-XT190.
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Endoscope
Hazard
  • device-lodging
  • design-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: 04953170402470
  • All Serial Numbers.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category