The Recall Desk

Manufacturer

Nellcor Puritan Bennett Inc. (dba Covidien LP)

11 recalls in our database name Nellcor Puritan Bennett Inc. (dba Covidien LP) as the manufacturing or recalling firm.

What the numbers show

Total
11
Critical
0
Severe
2
Most recent
2014-12-17

Of the 11 recalls from Nellcor Puritan Bennett Inc. (dba Covidien LP) we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (18%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–11 of 11

  • ModerateFDA (Devices)·Z-0180-2015·2014-12-17

    Covidien Recalls Puritan Bennett 980 Ventilators Due to Capacitor Failure

    Nellcor Puritan Bennett is recalling 324 Puritan Bennett 980 Ventilators because a capacitor component can fail, causing a dim screen and thermal odor.

    Product
    Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0112-2015·2014-11-05

    FDA Recalls 324 Puritan Bennett 980 Ventilators Due to Software Issue

    The FDA is recalling 324 Puritan Bennett 980 ventilators because a software issue may cause the devices to become inoperative.

    Product
    Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2234-2014·2014-08-20

    Vital Sync Virtual Patient Monitoring Platform software recall for alarm mismatch

    Nellcor Puritan Bennett Inc. is recalling Vital Sync software due to a mismatch between alarm priorities on medical devices and the monitoring system.

    Product
    Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals fo
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-2235-2014·2014-08-20

    Vital Sync Virtual Patient Monitoring Platform Recalled for Alarm Priority Mismatch

    Nellcor Puritan Bennett Inc. is correcting Vital Sync Virtual Patient Monitoring Platform units due to a mismatch between device alarm priorities and the system.

    Product
    Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professiona
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1844-2014·2014-07-02

    Puritan Bennett 840 Ventilator Recall for Display Loss

    Nellcor Puritan Bennett is recalling 104 Puritan Bennett 840 Ventilators due to reports of loss of graphical user interface display information while the device continues to provide breath support.

    Product
    Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. It is used in hospit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1809-2014·2014-06-25

    Nellcor Puritan Bennett PB840 Ventilator Display Component Recalled

    Nellcor Puritan Bennett Inc. is recalling Backlight Inverter Printed Circuit Boards for PB840 Ventilators due to a potential loss of the graphical user interface display.

    Product
    Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840 Ventilator: The Backlight Inverter Printed Circuit Board (BLI PCBA) for the 9.4 Display part number 4-079056-00. The PB840 Ventilator System is intended to provide in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1577-2014·2014-05-21

    Newport Medical e360 Ventilator Component Recalled for Audible Alarm Failure

    Nellcor Puritan Bennett is recalling 5,765 single board computer components for the Newport Medical e360 Ventilator because the audible alarm may not sound during alarm states.

    Product
    Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Intended to provide invasive or noninvasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0822-2014·2014-01-29

    Puritan Bennett Ventilator Manual Labeling Correction for Oxygen Sensor Life

    Nellcor Puritan Bennett is correcting operator and service manuals for PB700 and PB840 ventilators to clarify the operational life of the oxygen sensor.

    Product
    Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operators Manual: PN 10066984 & PN G-061874-00 and PB700 Series Service Manual: PN 10070389 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0821-2014·2014-01-29

    Puritan Bennett Ventilator Manual Addendum Corrected for Oxygen Sensor Life

    Nellcor Puritan Bennett is correcting a labeling error in the PB840 Operator's Manual Addendum that incorrectly stated the oxygen sensor life as two years instead of one.

    Product
    Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient wye (inspiratory-expiratory interface). The oxygen sensor does not control t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2301-2012·2012-09-05

    Recall of DGHP RFA High-Power Grounding Pads Due to Burn Risk

    Nellcor Puritan Bennett Inc. is recalling DGHP RFA High-Power grounding pads and electrode kits because foil degradation may cause electrical burns to patients.

    Product
    DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The product is used during ablation surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2174-2012·2012-08-22

    Shiley Reusable Tracheostomy Tubes Recalled Due to Cannula Connection Issues

    Nellcor Puritan Bennett Inc. is recalling Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes due to consumer complaints regarding the connections and functions of the inner and outer cannula.

    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 an
    Category
    Medical Device
    Distribution
    Distributed nationwide