Armstrong Grommet with wire Otological Ventilation Tube Catalog #:… — Class II medical device recall Z-1731-2014
Terminated recall by Summit Medical, Inc., reported 2014-06-18, distributed in CA. One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventilation tubes w
| Recall number | Z-1731-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Summit Medical, Inc., Eagan, MN, United States |
| Recall initiated | 2014-05-12 |
| Classified | 2014-06-09 |
| Reported by FDA | 2014-06-18 |
| Terminated | 2014-06-19 |
| Distributed | CA |
| Countries outside the US | DE |
| Quantity | 9 boxes |
| Lot numbers | 147809 |
| Model numbers | VT-0507-01 |
Product
Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only. Intended to provide ventilation to the middle ear space through the tympanic membrane.
Reason for recall
One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventilation tubes with wire attached to the straight flange. This poses no health hazard to the user or patient.
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-1731-2014. 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.