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EVIS EXERA III BRONCHOVIDEOSCOPE recallZ-0053-2026 · Olympus Corporation of the Americas · initiated Sep 11, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

FDA root cause category: Device Design

What the company is doing

An URGENT Medical Device Correction notification dated 9/11/25 was mailed to consignees to notify them of this recall action. Consignees are asked to carefully read the recall notification and identify any affected devices in their inventory. Consignees are to ensure all personnel are knowledgeable and aware of the updated IFU. Consignees are to acknowledge receipt of the recall notification through Olympus' web portal at https://olympusamerica.com/recall. Forward the provided recall notification if product was further distributed. Consignees with any questions can contact Cynthia Ow by phone at 647-999-3203 or by email at [email protected].

Recall details

Recall number
Z-0053-2026
Status
Open, Classified
Initiated by the company
Sep 11, 2025
Posted by the FDA
Oct 16, 2025
Recalling firm
Olympus Corporation of the Americas
Quantity
5,221 units US; 4,321 units OUS
Product code
EOQ
FDA submissions
K121959
Distribution
US Nationwide Distribution.

Product description

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190

Code information (models, lots, serial numbers)

Model No. BF-H190; UDI: 4953170335174; All Serial No.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

10 devices cleared under K121959 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 97441).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page