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Open, Classified

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

FDA Recall Z-0557-2024 · Posted 2023-12-14

Recalling FirmOlympus Corporation of the Americas
Recall StatusOpen, Classified
Product CodeEOQ
Date Initiated2023-09-28
Product Quantity75

Reason for Recall

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

Firm Action

An Urgent Medical Device notification dated November 1, 2023 issued via UPS Ground. The notice advises customers to examine inventory for affected serial numbers and quarantine affected product. Contact Olympus Customer Solutions Team (1-800-848-9024, option 3) to arrange for for return. Olympus will inspect and repair if necessary. Customers are to forward notice to any facility affected product may have been transferred to. Olympus requests that you acknowledge receipt of this letter with [email protected].

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981543OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENTThe Olympus Optical Co. · 1998-06-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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