The Recall Desk

Hazard

Medical Device Defect recalls

33 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
33
Critical
0
Severe
1
Most recent
2026-08-12

Of the 33 medical device defect recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (3%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all medical device defect recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

26–33 of 33

  • HighFDA (Devices)·Z-2229-2017·2017-06-14

    ConvaTec Recalls Rebreathing Masks with Reservoir Bags and Tubing

    ConvaTec, Inc. is voluntarily recalling Rebreathing Masks, Reservoir bags, with Tubing (Product Code 104MM) due to a Class II safety concern.

    Product
    Rebreathing Mask, Reservoir bag, with Tubing, Product Code 104MM
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2242-2017·2017-06-14

    ConvaTec Recalls Infant High Concentration Non-Rebreather Oxygen Masks

    ConvaTec is recalling specific lots of infant high concentration non-rebreather oxygen masks due to a Class II safety concern.

    Product
    Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, Two Side Valves, Product Code 3266-E
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2237-2017·2017-06-14

    ConvaTec Recalls Elongated Adult Non-Rebreather Oxygen Masks

    ConvaTec is voluntarily recalling specific lots of elongated adult non-rebreather oxygen masks. The recall was initiated in 2017 and is now terminated.

    Product
    Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, One Side Valve, FITS-All Conn., Product Code 3106-E
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1048-2017·2017-01-25

    Endologix AFX Endovascular AAA System Recall for Updated Endoleak Information

    Endologix is recalling 34 units of the AFX Endovascular AAA System to provide updated information regarding Type III endoleak rates and patient surveillance.

    Product
    AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V F0070308 A2828/C75 V F0070312 A3434/C80 V f00553 I1616/C55F SA F00556 I2013/C70F SA F00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0853-2016·2016-03-02

    Philips IntelliVue Measurement Module X1 Recalled for ST Alarm Failure

    Philips is recalling 13,300 IntelliVue Measurement Module X1 units because the ST elevation alarm may not sound for specific ECG leads.

    Product
    Philips IntelliVue Measurement Module X1 Model: M3001A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0003-2016·2015-10-07

    Biosense Webster Recalls SOUNDSTAR eco Diagnostic Ultrasound Catheters

    Biosense Webster is recalling SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters because the ultrasound image may disappear if the CARTO 3 system restarts during a pericardial effusion.

    Product
    SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0821-2013·2013-02-20

    Viterion TeleHealth Monitors Fail to Transmit Out-of-Range Blood Glucose Readings

    Viterion TeleHealth Monitors are being recalled because they do not transmit out-of-range blood glucose readings from specific Bayer and Roche meters to healthcare professionals.

    Product
    Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Physiological patient monitor (without arrhythmia detection or alarms) . Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0018-2013·2012-10-17

    Accutron Recalls Ultra PC Cabinet Mount Packages Due to Flowmeter Defect

    Accutron is recalling 220 Ultra PC Cabinet Mount Packages because the flowmeter may function incorrectly when nitrous gas flows without oxygen.

    Product
    Ultra PC% Cabinet Mount Package G, Model #36600, Serial # 13593, 13594, 13595, 13596, 13597, 13598, 13599, 13600, 13602, 13605, 13610, 13611, 13612, 13615, 13616, 13617, 13621, 13622, 13624, 13625, 13627, 13628, 13633, 13634, 13635, 13636, 13637, 13638, 13639, 13640, 13642, 136
    Category
    Medical Device
    Distribution
    Distributed nationwide