The Recall Desk
HighFDA (Devices)·Z-2503-2023·Announced 2023-09-06

Olympus Bronchovideoscope Recalled for Risk of Lodging in Airway Connector

Olympus Corporation is recalling 1,004 units of the Bronchovideoscope Model BF-3C160 due to a dimensional defect that can cause the endoscope to become lodged in an 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: FDA classified this as a Class II recall. Although the dimensional defect poses a risk of device lodging during medical procedures, no injuries or hospitalizations have been reported in the source material. This meets the rubric criterion for High severity: a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Olympus Corporation of the Americas is recalling 1,004 units of the Bronchovideoscope Model BF-3C160 nationwide. This endoscope is used in bronchoscopy procedures for airway examination.

A complaint has been received that the endoscope model can become lodged in an endotracheal tube connector during use. The defect is attributed to the endoscope having an outside diameter that is too large. An endotracheal tube connector is a standard component used in airway management and anesthesia procedures.

The affected units are identified by UDI-DI 04953170340031 and 04953170063039, with all serial numbers of Model BF-3C160 included in this recall.

The recalled product

Product
Olympus Bronchovideoscope, Models BF-3C160.
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Endoscopy
Hazard
  • mechanical-entrapment
  • device-malfunction

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: 04953170340031 & 04953170063039
  • All Serial Numbers.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category