Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes Recalled by Nellcor Puritan Bennett Inc. (dba Covidien LP) Due to Covidien is recalling certain cuffed Shiley tracheostomy tubes...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Nellcor Puritan Bennett Inc. (dba Covidien LP) directly.
Affected Products
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.
Quantity: 337,227 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Nellcor Puritan Bennett Inc. (dba Covidien LP)
Nellcor Puritan Bennett Inc. (dba Covidien LP) has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report