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Critical recall: Death or serious injury has been reported or is considered likely. Stop using this product now.

Olympus Corporation of the Americas 2023-07-26 Health critical FDA
Health · FDA · Recall #FDA-Z-2012-2023

Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2 Recall

Issued July 26, 2023 · Olympus Corporation of the Americas

In July 2023, Olympus Corporation of the Americas recalled the Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.

Compiled by Maya Ellison, RecallCheckr

What this means for you

There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.

What you should do

  1. 1 Stop using Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2 right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact Olympus Corporation of the Americas to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
Olympus Corporation of the Americas
Category
Health
Recall date
July 26, 2023
Units affected
Not reported
Sold at
US Nationwide Distribution.
Recall number
FDA-Z-2012-2023
Made in
United States
Issuing agency
FDA

In context

  • Olympus Corporation of the Americas has 42 recalls in our database, including 6 rated Critical.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 903rd Health recall we've logged in 2023.
Read the official FDA notice

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