The Recall Desk
ModerateFDA (Devices)·Z-2567-2021·Announced 2021-10-06

Olympus Bronchofiberscope BF-1T60 Receives Updated Reprocessing Instructions Nationwide

Olympus Corporation is issuing updated reprocessing instructions for the BF-1T60 bronchofiberscope to comply with FDA 2015 guidance on device reprocessing in health care settings.

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: Class II medical device with no reported illnesses or injuries. This recall represents a precautionary update of reprocessing instructions to comply with FDA 2015 guidance, meeting the criterion for voluntary precautionary recalls.

Plain-English summary

Olympus Corporation of the Americas is issuing validated, new reprocessing instructions for the BF-1T60 OES Bronchofiberscope model, in accordance with FDA 2015 guidance. All 350 units of this device model are affected, with distribution spanning the United States and globally.

Health care facilities using this bronchofiberscope should implement the updated reprocessing instructions provided by Olympus. These instructions detail the validated procedures for preparing the device for clinical use.

Contact Olympus Corporation of the Americas for the complete updated instructions and any additional information regarding this recall.

The recalled product

Product
BF-1T60 OES Bronchofiberscope, Model No. BF-1T60
Manufacturer
Olympus Corporation of the Americas
Hazard
  • sterilization

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.