Device recall: Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.)…

Class I FDA enforcement event 62559. Recall start date: 18 Jul 2012. Status in the FDA record: Terminated. Termination date: 22 Jan 2015.

Reason for recall, in the words of FDA

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.

Class I, in the words of FDA

a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

Nellcor Puritan Bennett Inc. (dba Covidien LP) started this device recall on 18 Jul 2012. The firm address in the FDA record is in Boulder, CO. FDA put the recall in Class I. FDA event 62559 has 1 product record. The first FDA enforcement report date is 22 Aug 2012. The record gives the status Terminated, with the termination date 22 Jan 2015.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide Distribution - US Nationwide

Recalling firm

Nellcor Puritan Bennett Inc. (dba Covidien LP), Boulder, CO.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 62559: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2174-2012	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.…	337,227 units	Class I	Terminated	22 Aug 2012

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

The event in context

Device events that started in 2012: 823
Share of these events in Class I: 5%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 9

Other events of the firm

Other FDA enforcement events of Nellcor Puritan Bennett Inc. (dba Covidien LP)
Initiated	Product (first record)	Type	Class	Records
1 Oct 2014	Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.	Device	Class I	1
1 Oct 2014	Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital t	Device	Class I	1
17 Jul 2014	Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packag	Device	Class II	2
4 Jun 2014	Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840 Ventilator: T	Device	Class II	1
3 Jun 2014	Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-inva	Device	Class II	1
18 Apr 2014	Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number S	Device	Class II	1
25 Jan 2013	Puritan Bennett 840 Series Ventilator PB840 Operator’s Manual Addendum PN 066009A 09/02 The intended use of the oxygen s	Device	Class II	2
1 Aug 2012	DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single u	Device	Class II	1

Nellcor Puritan Bennett Inc. (dba Covidien LP): all 9 events

Official channels

FDA enforcement report Z-2174-2012The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 62559. https://recallregister.com/fda/i/62559/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide Distribution - US Nationwide
What quantity of product is in FDA event 62559?: The FDA record gives this quantity: 337,227 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2012 have the same class?: 5% of the 823 device events that started in 2012 are in Class I.