The Recall Desk

Manufacturer

Covidien LP (formerly Nellcor Puritan Bennett Inc.)

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

What the numbers show

Total
7
Critical
1
Severe
1
Most recent
2016-03-23

Of the 7 recalls from Covidien LP (formerly Nellcor Puritan Bennett Inc.) we have scored against our rubric, 1 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (14%) 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.

1–7 of 7

  • SevereFDA (Devices)·Z-1181-2016·2016-03-23

    Puritan Bennett 980 Ventilator Recalled for Touchscreen and Ventilation Issues

    Medtronic is recalling 1,864 Puritan Bennett 980 ventilators worldwide due to unresponsive touchscreens and potential loss of primary ventilation.

    Product
    Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for pediatric and adult patients who require either invasive ventilation or non-invasive ventilation.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2329-2015·2015-08-26

    FDA Recalls 657 Puritan Bennett 980 Ventilators Due to Volume Defects

    The FDA is recalling 657 Puritan Bennett 980 Ventilators because tidal volumes may be lower than set in neonatal mode, potentially causing respiratory compromise.

    Product
    Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2267-2015·2015-08-05

    OxiMax N-65 Pulse Oximeters Recalled for Display Segment Defects

    FDA is recalling OxiMax N-65 handheld pulse oximeters because missing display segments may cause users to misinterpret oxygen saturation and pulse rate data.

    Product
    OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2268-2015·2015-08-05

    OxiMax N-560 Pulse Oximeters Recalled for Display Segment Defects

    The FDA is recalling OxiMax N-560 Pulse Oximeters because missing display segments may cause users to misinterpret oxygen saturation and pulse rate data.

    Product
    OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1951-2015·2015-07-15

    Shiley Pediatric Tracheostomy Tubes Recalled for Breathing Difficulties

    FDA recalls Shiley tracheostomy tubes due to reports of patient discomfort and breathing difficulties.

    Product
    Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1950-2015·2015-07-15

    Shiley Neonatal and Pediatric Tracheostomy Tubes Recalled for Breathing Difficulties

    FDA is recalling Shiley Neonatal and Pediatric Tracheostomy Tubes because patients reported discomfort and breathing difficulties after switching to these products.

    Product
    Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. Model Numbers: 2.5NEF,3.0NEF,3.5NEF,4.0NEF,4.5NEF,2.5PEF,3.0PEF,3.5PEF,4.0PEF,4.5PEF,5.0PEF,5.5PEF,5.0PELF,5.5PELF,6.0PELF,6.5PELF,2.5NCF,3.0NCF,3.5NCF,4.0NCF,4.5NCF,2.5PCF,3.0PCF,3.5PCF,4.0PCF,4.5PCF,5.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1058-2015·2015-02-11

    Puritan Bennett 980 Ventilator Recalled for Occasional GUI Resets

    Covidien is voluntarily recalling 418 Puritan Bennett 980 ventilators due to occasional graphical user interface resets lasting approximately 30 seconds.

    Product
    Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum
    Category
    Medical Device
    Distribution
    Distributed nationwide