The Recall Desk

Hazard

Device Malfunction recalls

1,800 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,800
Critical
31
Severe
370
Most recent
2026-09-02

Of the 1,800 device malfunction recalls we have scored against our rubric, 31 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 370 (21%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all device malfunction 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.

1401–1425 of 1800

  • HighFDA (Devices)·Z-1192-2016·2016-03-30

    QiG Group Recalls Algovita Implanted Pulse Generators Due to Connection Issues

    QiG Group LLC is recalling 40 Algovita Implanted Pulse Generators because they may fail to connect to external devices unless held very close.

    Product
    Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1193-2016·2016-03-30

    QiG Group Recalls Algovita Implanted Pulse Generators Due to Connection Issues

    QiG Group LLC is recalling 34 Algovita Implanted Pulse Generators because they may fail to connect to external devices unless held very close, preventing reprogramming and recharging.

    Product
    Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)
    Category
    Medical Device
    Distribution
    0 states
  • 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-1187-2016·2016-03-23

    Medtronic Recalls Covidien Emprint Percutaneous Antenna Due to Generator Shutdown Risk

    Medtronic is voluntarily recalling specific lots of the Covidien Emprint Percutaneous Antenna because the generator may shut down during high-temperature measurements.

    Product
    Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneous Antenna with Thermosphere" Technology; The product is packaged in a blister with a tyvek lid, contained in a display box. The numbers of units per carton is 1. Long Percutaneous Antenna with Thermosp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1044-2016·2016-03-09

    ConvaTec Recalls Opti-Mist Nebulizer Masks Due to Reduced Aerosol Output

    ConvaTec is recalling Opti-Mist and Opti-Mist Clear nebulizer masks because a component defect reduces or stops aerosol output, potentially preventing patients from receiving medication.

    Product
    Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0921-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 326 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548350 (XMD P/N 70-0050-214) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0935-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 189 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548530 (XMD P/N 70-0050-416) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0975-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem Mediem Medical Devices Inc is recalling 36 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number M00548430 (XMD P/N 70-0050-A14) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The Endo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0981-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem Mediem Medical Devices Inc is recalling 39 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548320 (XMD P/N 70-0050-B12) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0930-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage

    Xeridiem is recalling 34 EndoVive 3s Low Profile Balloon Kits because the feeding valve may leak gastric contents when disconnected.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548840 (XMD P/N 70-0050-320) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0992-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 126 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00549420 (XMD P/N 70-0050-C22) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0896-2016·2016-03-02

    Olympus Video Colonoscopes Recalled Due to Internal Coil Detachment Risk

    Integrated Medical Systems Inc is recalling 82 Olympus CF-Q180AL video colonoscopes because excessive pressure may cause the internal coil pipe to detach, preventing proper angulation.

    Product
    Olympus, Model No. CF-Q180AL, flexible scope, large diameter, video colonoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0904-2016·2016-03-02

    Olympus Video Gastroscope Recall Due to Internal Coil Detachment Risk

    Integrated Medical Systems Inc. is recalling 54 Olympus GIF-Q160 video gastroscopes because excessive pressure may cause the internal coil pipe assembly to detach, preventing proper angulation.

    Product
    Olympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0924-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548830 (XMD P/N 70-0050-220) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1006-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 31 EndoVive 3s Low Profile Balloon Kits because the feeding valve may leak gastric contents or feeding solution when disconnected.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548640 (XMD P/N 70-0050-F16) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0933-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage

    Xeridiem is recalling 38 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548250 (XMD P/N 70-0050-412) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0942-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 186 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548540 (XMD P/N 70-0050-516) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0897-2016·2016-03-02

    Olympus Video Colonoscope Recall Due to Internal Coil Detachment Risk

    Integrated Medical Systems is recalling five Olympus video colonoscopes because the internal coil pipe assembly may detach if excessive pressure is applied to the distal end.

    Product
    Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0934-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 323 EndoVive 3s Low Profile Balloon Kits because the feeding valve may leak gastric contents or feeding solution.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548370 (XMD P/N 70-0050-414) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1015-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem Mediem Medical Devices Inc. is recalling 32 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00549460 (XMD P/N 70-0050-G22) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0945-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem Mediem Medical Devices Inc is recalling 36 EndoVive 3s Low Profile Balloon Kits because the feeding valve may leak gastric contents.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M005489350 (XMD P/N 70-0050-522) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The En
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0980-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00549540 (XMD P/N 70-0050-A24) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0960-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 43 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00549510 (XMD P/N 70-0050-724) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0915-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 199 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548340 (XMD P/N 70-0050-114) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0893-2016·2016-03-02

    Olympus Video Gastroscope Recall Due to Detached Internal Coil Assembly

    Integrated Medical Systems Inc is recalling 180 Olympus GIF-H180J video gastroscopes because excessive pressure can cause the internal coil pipe assembly to detach, preventing proper angulation.

    Product
    Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope
    Category
    Medical Device
    Distribution
    Distributed nationwide