Z-0557-2024Class II

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

Name: Z-0557-2024 TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP
Creator: Olympus Corporation of the Americas
Published: 2023-09-28
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2023-09-28 / Open, Classified

FDA source

Olympus Corporation of the Americas began a recall of TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP on 2023-09-28. FDA classified it as Class II and gives the reason as "Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0557-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-28
Posted: 2023-12-14
Recalling firm: OLYMPUS Corporation of the Americas
Product: TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP
Product code: EOQ Bronchoscope (Flexible Or Rigid)
Reason for recall: Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification.
FDA root cause: Under Investigation by 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].
Quantity in commerce: 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.
Product codes and lots: UDI-DI: 04953170340215 & UDI-DI: 04953170061998. Serial numbers: 2515143, 2515181, 2515449, 2515549, 2615760, 2615761, 2615763, 2615825, 2615830, 2615831, 2616057, 2616130, 2616199, 2716417, 2817430, 2917855, 2917867, 2917997, 2918003, 2918010, 2918012, 2918030, 2018337, 2018435, 2018486, 2018543, 2018571, 2018675, 2319768, 2319820, 2510582, 2621001.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0557-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0557-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-20	2023-12-14

Product code EOQ

K981543Class IIOlympus Lf-Tp and Lf-Dp Tracheal Intubation Fiberscopes, Accessories and Ancillary EquipmentThe Olympus Optical Co. / cleared 1998-06-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)