Duravent Silicone Ventilation Tubes recalled for product substitution error
Olympus is recalling 984 Duravent Silicone Ventilation Tubes (Model 240075) due to the potential that some units may contain incorrect product—specifically 1.32 mm Tiny T Tubes (Model 70240076) instead of the intended product.
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 involving a product substitution error where the wrong model ventilation tube may have been shipped. While no illnesses or injuries have been reported, the use of an incorrect ventilation tube in clinical procedures poses a risk of harm, fitting the rubric criterion for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling 984 units of Duravent Silicone Ventilation Tubes, Model Number 240075, distributed across multiple U.S. states and internationally.
The company identified a potential that some units may contain incorrect product—specifically 1.32 mm Tiny T Tubes (Model 70240076) instead of the intended Duravent Silicone Ventilation Tubes. Using the incorrect ventilation tube could pose a clinical risk.
The recalled units have lot numbers SM405666 and JB362646. Distribution included Alabama, Arizona, California, Illinois, Kentucky, Maryland, Minnesota, Missouri, North Carolina, North Dakota, New York, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Washington, and Wisconsin. Units were also distributed internationally to Australia, Canada, and Germany.
If you received these ventilation tubes, contact Olympus regarding the recall. Do not use the affected units and arrange for replacement or credit.
The recalled product
- Product
- Duravent Silicone Ventilation Tube. Model Number: 240075.
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- Affected units
- 984
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 (3)
- Model Number: 240075. UDI: 00521925031883 (17)331015 (10)SM405666
- Lot Number: SM405666. UDI: 00521925031883 (17)331015 (10)JB362646
- Lot Number: JB362646.
Distribution
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