Olympus Paparella-Type Vent Tube Recall: Missing Expiration Date on Inner Packaging
Olympus Corporation of the Americas is recalling one lot of Paparella-Type Vent Tubes due to missing expiration date on the inner package, though the date is present on the outer packaging.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II medical device recall with no reported illnesses or injuries. This is a minor labeling defect involving a missing expiration date on primary packaging.
Plain-English summary
Olympus Corporation of the Americas is recalling 600 units of Paparella-Type Vent Tubes, Model 240044, sterile medical devices intended to ventilate the middle ear following otitis media treatment.
The recalled lot (SM280573, UDI 00821925031913) has an expiration date of February 12, 2033, which is printed on the secondary (outer) packaging but is missing from the primary (inner) packaging. The absence of the expiration date on the inner package creates a labeling defect.
The affected lot was distributed worldwide, including in the United States and Australia.
The recalled product
- Product
- Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device
- Affected units
- 600
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 (1)
- UDI: 00821925031913 Lot Number: SM280573
Distribution
Distributed nationwide across the United States.
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