Olympus tracheal intubation fiberscope recalled due to suction flow specification issue
Olympus tracheal intubation fiberscopes are being recalled because the manufacturer lacks adequate data confirming the suction flow rate meets device specifications. No injuries have been reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with no reported hospitalizations or injuries. However, the identified specification non-compliance affects a critical airway management device, representing a risk-of-harm product where proper function is essential for patient safety.
Plain-English summary
Olympus Corporation of the Americas is recalling 75 units of the TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP (Model LF-GP) worldwide due to insufficient data confirming that the suction flow rate meets device specifications.
The affected devices were distributed across the United States (Alaska, Alabama, Arizona, California, Georgia, Illinois, Indiana, Massachusetts, Maryland, Michigan, North Carolina, New Jersey, Ohio, Texas, Utah, Virginia, Washington, West Virginia, and Armed Forces Pacific), and internationally in EMEA, Japan, and Australia. The devices are identified by UDI-DI codes 04953170340215 and 04953170061998, with specific serial numbers documented in the recall notice.
Healthcare providers currently using these fiberscopes should verify the device serial number against the recall list and contact Olympus Corporation of the Americas for further guidance. Do not use affected units until receiving instructions from the manufacturer.
The recalled product
- Product
- TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 75
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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