Recall Z-0557-2024— Olympus Corporation of the Americas

Name: FDA recall Z-0557-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-28

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2023-09-28. It names one FDA 510(k) clearance: K981543. Product: TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP. Reason: Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2023-09-28
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K981543 — OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENTThe Olympus Optical Co.·cleared 1998-06-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.