Hudson RCI — Class II medical device recall Z-1078-2015
Terminated recall by Teleflex Medical, reported 2015-02-18, distributed in FL, GA, IL, KY, MA, MI, MO, MS…. Labeling; The affected product packaging is incorrectly labeled as being a cuffed oral ET tube; The correct pr
| Recall number | Z-1078-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Research Triangle Park, NC, United States |
| Recall initiated | 2015-01-09 |
| Classified | 2015-02-10 |
| Reported by FDA | 2015-02-18 |
| Terminated | 2016-09-27 |
| Distributed | FL, GA, IL, KY, MA, MI, MO, MS, OH, TX, WA, WV |
| Countries outside the US | CA, NL |
| Quantity | 300 units |
| Reason classes | labeling |
| Lot numbers | 01M1300076 |
| Model numbers | 5-22110 |
Product
Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical.
Reason for recall
Labeling; The affected product packaging is incorrectly labeled as being a cuffed oral ET tube; The correct product labeling is uncuffed nasal ET tube.
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-1078-2015. 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.