Class I — Bryan Medical Inc
| Recalling firm | Bryan Medical Inc. |
|---|---|
| Registered facility | BRYAN MEDICAL INC. (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes. |
| Product | Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access. |
| Quantity | 5 units |
| Distribution | Distributed in KY and AL. |
| Initiated | 2013-04-17 |
| Classified | 2013-07-08 |
| Terminated | 2013-10-29 |
| Recall number | Z-1667-2013 |
| 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 I recall — Bryan Medical Inc (Z-1667-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65449/
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