The Recall Desk
ModerateFDA (Devices)·Z-2573-2021·Announced 2021-10-06

Olympus Bronchovideoscope Model BF-Q180-AC Recalled for Updated Reprocessing Instructions

Olympus Corporation is recalling 431 BF-Q180-AC EVIS EXERA II Bronchovideoscopes to issue validated reprocessing instructions aligned with FDA 2015 guidance.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II device recall involving reprocessing instructions with no reported illnesses or injuries. The update aligns with FDA guidance and applies to procedural labeling rather than a device defect.

Plain-English summary

Olympus Corporation of the Americas is recalling the BF-Q180-AC EVIS EXERA II Bronchovideoscope. The recall affects 431 units distributed domestically and globally, encompassing all serial numbers of this model.

The firm is issuing validated, new reprocessing instructions according to FDA 2015 guidance on reprocessing medical devices in health care settings.

The recalled product

Product
BF-Q180-AC EVIS EXERA II Bronchovideoscope, Model No. BF-Q180-AC
Manufacturer
Olympus Corporation of the Americas
Hazard
  • reprocessing

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

Distribution

Distributed nationwide across the United States.