Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes — Class I medical device recall Z-2174-2012
Terminated recall by Nellcor Puritan Bennett Inc. (dba Covidien LP), reported 2012-08-22, distributed nationwide. Covidien is recalling certain cuffed Shiley tracheostomy tubes due to consumer complaints related to the conne
| Recall number | Z-2174-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nellcor Puritan Bennett Inc. (dba Covidien LP), Boulder, CO, United States |
| Recall initiated | 2012-07-18 |
| Classified | 2012-08-10 |
| Reported by FDA | 2012-08-22 |
| Terminated | 2015-01-22 |
| Distributed | Nationwide (US) |
| Quantity | 337,227 units |
| Lot numbers | 0910000342, 0910000348, 0910001002, 0910001010, 0910002075, 1003002176, 1004000412, 1101001558, 1101001823, 110200327X, 1103002052, 1103002299, 110300622X, 110601803X, 111000400X, 120100433X, 120402125X, 120600014X, 120600351X, 120600700X, 8FEN-S, 8FENJ-S, 8LPC, 8LPC-S |
| Model numbers | 8FEN, 8FEN-S, 8FENJ, 8FENJ-S, 8LPC, 8LPC-S |
Product
Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FENJ, 8FENJ-S, 8LPC-S, 8FEN-S. Product Usage: The product is intended for use to bypass upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. The product is sold as sterile. The packaging may indicate either Covidien or Tyco as the manufacturer as the firm has transitioned from Tyco to Covidien over the past 4 years.
Reason for recall
Covidien is recalling certain cuffed Shiley tracheostomy tubes due to consumer complaints related to the connections and functions of the inner and outer cannula which were observed during mechanical ventilation of patients.
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-2174-2012. 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.