Olympus/Gyrus Paparrela-Type Vent Tube 1 — Class II medical device recall Z-1004-2024
Ongoing recall by Olympus Corporation of the Americas, reported 2024-02-14, distributed nationwide. The expiration date is missing from the primary (inner) packaging. The secondary (outer) box label correctly s
| Recall number | Z-1004-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2023-12-11 |
| Classified | 2024-02-07 |
| Reported by FDA | 2024-02-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU |
| Quantity | 600 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00821925031913 |
| Lot numbers | SM280573 |
| Model numbers | 240044 |
Product
Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
Reason for recall
The expiration date is missing from the primary (inner) packaging. The secondary (outer) box label correctly states the expiration date of February 12, 2033, for this lot
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1004-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.