Tracoe Mini 3 — Class I medical device recall Z-1667-2013
Terminated recall by Bryan Medical Inc, reported 2013-07-17, distributed in AL, KY. The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.
| Recall number | Z-1667-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bryan Medical Inc, Cincinnati, OH, United States |
| Recall initiated | 2013-04-17 |
| Classified | 2013-07-08 |
| Reported by FDA | 2013-07-17 |
| Terminated | 2013-10-29 |
| Distributed | AL, KY |
| Quantity | 5 units |
| Reason classes | labeling |
| Lot numbers | 000-1000071752 |
| Model numbers | 350-3.0 |
Product
Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.
Reason for recall
The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.
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-1667-2013. 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.