The Recall Desk

Manufacturer

Del Mar Reynolds Medical, Ltd.

8 recalls in our database name Del Mar Reynolds Medical, Ltd. as the manufacturing or recalling firm.

What the numbers show

Total
8
Critical
0
Severe
2
Most recent
2017-05-24

Of the 8 recalls from Del Mar Reynolds Medical, Ltd. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (25%) 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.

1–8 of 8

  • HighFDA (Devices)·Z-2093-2017·2017-05-24

    Spacelabs Arkon Anesthesia Delivery System Canister Carrier Recall

    Del Mar Reynolds Medical is recalling 62 Spacelabs Arkon Anesthesia Delivery System components because the canister carrier can break, causing a breathing circuit leak and potential patient hypoventilation.

    Product
    Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room. Absorber Adapter Assembly Service Kit, part number: 050-9045-00. Absorber Adapter Assembly, part number: 650-1648-01. Arkon Absorber Canister Carrier, p
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1460-2017·2017-03-22

    Arkon Anesthesia Delivery System Recalled for Unannounced Power Supply Failure

    Del Mar Reynolds Medical is recalling Arkon Anesthesia Delivery Systems because the power supply can fail without triggering normal battery alarms.

    Product
    Arkon Anesthesia Delivery System, Model 99999. Product Usage: Continuous Ventilator The Arkon Anesthesia Delivery System is designed to provide emergency oxygen, vaporized agent delivery and manual ventilation in the event of a power failure scenario. Clinicians are able to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1458-2015·2015-04-29

    Spacelabs Pediatric Flow Sensor Kit Recalled for Inaccurate Low Flow Readings

    Del Mar Reynolds Medical is recalling Spacelabs Pediatric Flow Sensor Kits because they report inspiratory and expiratory tidal volumes lower than the actual volumes delivered to patients.

    Product
    Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs Healthcare Blease 700/900 Series Ventilators. Designed specifically for the mechanical ventilation of adult and pediatric patients under general anesthesia.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1442-2014·2014-04-23

    SpaceLabs Arkon Anesthesia Delivery System Recalled for Software Failure

    Del Mar Reynolds Medical is recalling 16 SpaceLabs Arkon Anesthesia Delivery Systems with Version 2.0 software because they may enter a controlled failed state.

    Product
    SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0352-2014·2013-11-27

    Spacelabs recalls anesthesia workstation absorbers due to potential switch failure

    Spacelabs Healthcare is recalling CAS I/II Absorbers for Blease anesthesia workstations because the Bag-to-Vent switch may fail due to loose hardware.

    Product
    CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following part numbers: 12200900; 12200901; 12200902; 12200903; 14200100, and service kits part number 050-0659-00 and 050-0901-00. BleaseFocus Anest
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1771-2013·2013-07-31

    Spacelabs ARKON Anesthesia Workstation Recalled for Software Defect

    Del Mar Reynolds Medical is recalling nine Spacelabs ARKON Anesthesia Workstations due to a software defect that may cause false communication error alerts.

    Product
    Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0968-2013·2013-03-27

    Spacelabs Anesthesia Workstation Recall for Carbon Dioxide Defect

    Del Mar Reynolds Medical is recalling Spacelabs anesthesia workstations and service kits containing CAS I/II Absorbers due to a defect that may increase carbon dioxide levels in patient gas.

    Product
    Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation installed with the CAS I/II Absorber. Anesthesia workstation for use in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0565-2013·2012-12-26

    Del Mar Reynolds Medical Recalls BleaseFocus Anesthesia Workstations Due to Manual Error

    Del Mar Reynolds Medical is recalling BleaseFocus Anesthesia Workstations and 700/900 Series Ventilators because the user manuals describe a secondary oxygen supply failure alarm that is not actually installed in the devices.

    Product
    BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would co
    Category
    Medical Device
    Distribution
    Distributed nationwide