The Recall Desk
HighFDA (Devices)·Z-2492-2023·Announced 2023-09-06

Olympus Bronchovideoscope Model BF-Q180-AC Recalled for Lodging Risk

Olympus Corporation is recalling 416 units of the Bronchovideoscope Model BF-Q180-AC nationwide because the endoscope can become lodged in the endotracheal tube connector due to an oversized diameter.

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 for a mechanical defect where the endoscope can become lodged in the endotracheal tube connector. No injuries have been reported to date. It qualifies as High (Score 3) under the criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Olympus Corporation of the Americas is recalling 416 units of the Olympus Bronchovideoscope Model BF-Q180-AC distributed nationwide. The company initiated this recall following a complaint that the endoscope model can become lodged in the endotracheal tube connector because the endoscope's diameter is larger than intended.

The recalled units are identified by UDI-DI 04953170340086. All serial numbers of the Olympus Bronchovideoscope Model BF-Q180-AC are affected.

The recalled product

Product
Olympus Bronchovideoscope, Model BF-Q180-AC
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device
Hazard
  • equipment-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: 04953170340086
  • All Serial Numbers.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category