The Recall Desk
SevereFDA (Devices)·Z-2015-2023·Announced 2023-07-26

Olympus BRONCHOVIDEOSCOPE Model BF-Q170 Recalled Due to Combustion Risk

Olympus BRONCHOVIDEOSCOPE Model BF-Q170 is recalled nationally due to complaints of endobronchial combustion during therapeutic laser procedures, classified as FDA Class I.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification requires a minimum severity of 4 per the rubric. The source reports complaints of serious internal burn complications (endobronchial combustion) during device use, but does not report deaths or hospitalizations.

Plain-English summary

Olympus Corporation of the Americas is recalling the BRONCHOVIDEOSCOPE Model BF-Q170, classified as an FDA Class I recall. The device is used in therapeutic bronchoscopy procedures and is distributed nationwide in the United States.

There have been complaints of endobronchial combustion occurring during therapeutic laser procedures performed with this bronchoscope. Endobronchial combustion is a serious complication involving internal burning in the airway during device use.

The recalled product

Product
Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Bronchoscopy Equipment
Hazard
  • endobronchial-combustion
  • thermal-burn-injury

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 (1)

  • All serial numbers BF-Q170 BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 UDI: 04953170342912

Distribution

Distributed nationwide across the United States.

Related recalls

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