TRACHEAL INTUBATION FIBERSCOPE recallZ-0557-2024 · Olympus Corporation of the Americas · initiated Sep 28, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification.
FDA root cause category: Under Investigation by firm
What the company is doing
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].
Recall details
- Recall number
- Z-0557-2024
- Status
- Open, Classified
- Initiated by the company
- Sep 28, 2023
- Posted by the FDA
- Dec 14, 2023
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 75
- Product code
- EOQ
- FDA submissions
- K981543
- 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 description
TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP
Code information (models, lots, serial numbers)
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.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GPOlympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)3 recalls23 reports
- TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GPOlympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)2 recalls70 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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