The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2490-2023·Announced 2023-09-06

Olympus Bronchovideoscope models recalled for lodging risk in airway connectors

Olympus is recalling 1,715 Bronchovideoscope units across eight models due to a diameter defect that causes the device to lodge in the endotracheal tube connector.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 involving a medical device with a diameter defect that causes endoscope lodging in the endotracheal tube connector. Device entrapment during critical airway procedures presents a risk-of-harm scenario consistent with severity score 3.

Plain-English summary

Olympus Corporation of the Americas is recalling eight models of Bronchovideoscope endoscopes: BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, and BF-XT160. Approximately 1,715 units have been distributed nationwide in the United States.

The recall stems from a complaint that the endoscope becomes lodged in the endotracheal tube connector because the device diameter is too large. This mechanical fit problem can occur during clinical use.

Healthcare providers using these Bronchovideoscope models should contact Olympus Corporation of the Americas regarding this recall. The FDA has classified this as a Class II recall.

The recalled product

Product
Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160.
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Respiratory Endoscope
Hazard
Affected units
1,715

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 (16)

  • UDI-DI: 04953170308185
  • 04953170288968
  • 04953170308161
  • 04953170339264
  • 04953170308277
  • 04953170339394
  • 04953170308178
  • 04953170288876
  • 04953170308123
  • 04953170339196
  • 04953170062988
  • 04953170339974
  • 04953170063008
  • 04953170339998
  • & 04953170340147
  • All Serial Numbers.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 15 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 15 products in this recall →

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