FDA Devices recall · Reported August 22, 2012
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
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 observ…
Nellcor Puritan Bennett Inc. (dba Covidien LP) recalled Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide)… - a critical-severity action.
Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide)… was recalled by Nellcor Puritan Bennett Inc. (dba Covidien LP) in August 22, 2012. Reason: Covidien is recalling certain cuffed Shiley tracheostomy tubes due to consumer complaints related to the conn…. Check the official notice for the remedy. Verify recall #Z-2174-2012 with the FDA Devices before acting.
The recall
Nellcor Puritan Bennett Inc. (dba Covidien LP) issued this critical-severity FDA Devices recall-Covidien is recalling certain cuffed Shiley tracheostomy tubes due to consumer complaints related to the conn….
- Critical
- severity level
- 337K units
- affected scope
- Class I
- classification
- August 22, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2174-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope (see the Recall Profile below) is large enough to require multi-state distribution tracking. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2174-2012 |
| Date reported | August 22, 2012 |
| Date initiated | July 18, 2012 |
| Recalling firm | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| Firm location | Boulder, CO |
| Affected scope | 337,227 units |
| Distribution | Worldwide Distribution - US Nationwide |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2174-2012) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026