PlainRecalls
FDA Devices Moderate Class II Ongoing

TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP

Reported: December 20, 2023 Initiated: September 28, 2023 #Z-0557-2024

Product Description

TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP

Reason for Recall

Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification.

Details

Units Affected
75
Distribution
Worldwide - US Nationwide distribution in the states of AK, AL, AZ, CA, GA, IL, IN, MA, MD, MI, NC, NJ, OH, TX, UT, VA, WA, WV & AP (Armed Forces Pacific) and the countries of OUS: EMEA, Japan and Australia.
Location
Center Valley, PA

Frequently Asked Questions

What product was recalled?
TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP. Recalled by Olympus Corporation of the Americas. Units affected: 75.
Why was this product recalled?
Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 20, 2023. Severity: Moderate. Recall number: Z-0557-2024.