Class II — Summit Medical, Inc.
| Recalling firm | Summit Medical, LLC |
|---|---|
| Registered facility | SUMMIT MEDICAL LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 9 boxes |
| Distribution | Worldwide Distribution -- USA, including CA, and GERMANY. |
| Initiated | 2014-05-12 |
| Classified | 2014-06-09 |
| Terminated | 2014-06-19 |
| Recall number | Z-1731-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Summit Medical, Inc. (Z-1731-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68267/
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