The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

9701–9725 of 29157

  • SevereFDA (Devices)·Z-1806-2020·2020-05-06

    Philips TraumaDiagnost X-Ray System Recalled Due to Potential Shaft Failure

    Philips North America is recalling 346 TraumaDiagnost X-Ray systems because a shaft may break due to material fatigue, causing the arm to fall and potentially injure patients or staff.

    Product
    Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1836-2020·2020-05-06

    Radiometer ABL800 FLEX Blood Gas Analyzer Recall for Power Supply Defect

    Radiometer Medical ApS is recalling two ABL800 FLEX analyzers in California due to a power supply defect that may cause treatment delays and serious health risks.

    Product
    ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1825-2020·2020-05-06

    Elekta MONACO RTP System Recalled for Potential Inaccurate Radiation Dose Delivery

    Elekta Inc is recalling 96 MONACO RTP systems because the software may alter contour shapes, potentially resulting in inaccurate radiation dose delivery to patients.

    Product
    Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0925-2020·2020-05-06

    Whole Foods Market Recalls Minestrone Soup for Undeclared Milk

    Whole Foods Market is recalling Minestrone Soup sold in deli containers and bags because it may contain undeclared milk.

    Product
    Whole Foods Market Minestrone Soup PLU code printed on the product scale labels beginning with 248529 for soup sold in clear plastic deli-style containers of various weight and 246691 for soup sold in clear plastic bags weighing 7 lbs. 12 oz.
    Category
    Food
    Distribution
    33 states
  • SevereNHTSA·20V249000·2020-05-05

    Blue Bird Recalls Vision Buses Due to Fuel Line Chafing Risk

    Blue Bird is recalling 2018-2021 Vision buses with Ford 6.8L engines because parking brake cables may chafe fuel lines, creating a fire risk.

    Product
    BLUE BIRD — BLUE BIRD VISION, VISION TRANSIT BUS, VISION SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V251000·2020-05-05

    Freightliner M2 Trucks Recalled for Potential Loss of Drive Power

    Daimler Trucks is recalling 2019 Freightliner Business Class M2 trucks because a wire harness connector may unplug, causing sudden loss of drive power and power steering.

    Product
    FREIGHTLINER — FREIGHTLINER BUSINESS CLASS M2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V248000·2020-05-04

    Hyundai Recalls 2016 Genesis Coupe Due to Air Bag Mounting Bolt Issue

    Hyundai is recalling 2016 Genesis Coupe vehicles because driver-side air bag mounting bolts may be insufficiently tightened, posing an injury risk in a crash.

    Product
    HYUNDAI — HYUNDAI GENESIS COUPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V246000·2020-05-01

    Mercedes-Benz Recalls 2020 GLB 250 for Water Intrusion Electrical Risk

    Mercedes-Benz is recalling 2020 GLB 250 vehicles because water entering the foot wells may damage electrical components, causing the instrument cluster to go blank or the engine to stall.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLB 250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·20116·2020-05-01

    Epson Recalls Scanner Power Adapters Due to Fire and Burn Hazards

    Epson is recalling power adapters sold with V-series scanners because they can overheat, melt, and catch fire. Consumers should stop using them and contact Epson for a free replacement.

    Product
    Power adapters sold with Epson scanners
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V245000·2020-05-01

    Aprilia Motorcycles Recalled for Front Brake Pad Corrosion Risk

    Piaggio is recalling 3,287 Aprilia motorcycles because front brake pads may corrode and detach, increasing stopping distance and crash risk.

    Product
    APRILIA — APRILIA TUONO RF, RSV4 RR, RSV4 RF, TUONO RR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V243000·2020-04-29

    BMW Recalls 2017-2018 5 Series Vehicles for Head Air Bag Defect

    BMW is recalling 2017-2018 530i, 530e, and 540i vehicles because humidity exposure may impair head air bag deployment, increasing injury risk in crashes.

    Product
    BMW — BMW 540I, 530E, 530I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1768-2020·2020-04-29

    Acutus Medical Recalls Rhythm Xience Guider Catheter Introducers Due to Foreign Material

    Acutus Medical Inc is recalling 108 units of Rhythm Xience Guider Catheter Introducers because manufacturing defects may have left foreign material particulates on the devices.

    Product
    Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1745-2020·2020-04-29

    Wilson-Cook Recalls HEMO-7 Hemospray Endoscopic Hemostat Devices

    Wilson-Cook Medical is recalling HEMO-7 Hemospray Endoscopic Hemostat devices because the handle or activation knob may crack or break during activation, potentially causing the carbon dioxide cartridge to exit the handle.

    Product
    HEMO-7 Hemospray Endoscopic Hemostat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1771-2020·2020-04-29

    Acutus Medical Recalls AcQGuide Flex Steerable Introducer Due to Foreign Material

    Acutus Medical Inc is recalling 5 units of the AcQGuide Flex Steerable Introducer because manufacturing defects may have left foreign material particulates on the device.

    Product
    Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, SterileEO RxOnly
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1793-2020·2020-04-29

    bioMerieux PREVI Isola Printer Power Supply Units Recalled for Fire Hazard

    bioMerieux is recalling PREVI Isola printer power supply units due to a potential fire hazard. The affected units are distributed worldwide.

    Product
    PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units), P1028888-001 PSU (used in Zebra LP2824 Plus printers) PSUs with the following date code; 0639XX through 1253XX (YYWWXX, where YY=Year, and WW=week).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1770-2020·2020-04-29

    Acutus Medical Recalls Rhythm Xience Flextra Steerable Introducers Due to Foreign Material

    Acutus Medical Inc is recalling 30 units of Rhythm Xience Flextra Steerable Introducers because manufacturing defects may have left foreign material particulates on the devices.

    Product
    Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1769-2020·2020-04-29

    Acutus Medical AcQGuide Introducer Recalled for Foreign Material Particulates

    Acutus Medical Inc is recalling 268 units of AcQGuide Mini Fixed-Curve Introducers because manufacturing defects may have left foreign material on the devices.

    Product
    Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1746-2020·2020-04-29

    Wilson-Cook Recalls HEMO-10 Hemospray Endoscopic Hemostat Devices

    Wilson-Cook Medical is recalling HEMO-10 Hemospray Endoscopic Hemostat devices because the handle or activation knob may crack or break, potentially causing the carbon dioxide cartridge to exit the handle.

    Product
    HEMO-10 Hemospray Endoscopic Hemostat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1786-2020·2020-04-29

    Degania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures

    Degania Medical Devices is recalling specific lots of temperature sensing Foley catheters because inadequate incoming inspection practices were used on the thermistor sensors.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101863DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0911-2020·2020-04-29

    H & C Food Inc. Recalls Enoki Mushrooms Due to Listeria Risk

    H & C Food Inc. is recalling 2,500 units of 7.5oz Enoki Mushrooms potentially contaminated with Listeria monocytogenes. The product was distributed in New York, Maryland, and Virginia.

    Product
    Enoki Mushroom; 7.5oz (200g); UPC #831211204181; packed in clear plastic bag with green label; imported from Green Co. located in Korea; distributed from February 15th, 2020 to March 5th, 2020.
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·20V238000·2020-04-28

    Jayco Recalls 2020 Jay Flight SLX Trailers Due to Propane Leak Risk

    Jayco is recalling 2020 Jay Flight SLX travel trailers because an improperly tightened propane hose may leak, increasing the risk of fire or explosion.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER JAY FLIGHT SLX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V236000·2020-04-28

    Triumph Recalls Motorcycles Due to Front Brake Pad Corrosion Risk

    Triumph is recalling 3,709 motorcycles because front brake pads may corrode and detach, increasing stopping distance and crash risk.

    Product
    TRIUMPH — TRIUMPH XRX (LRH), STREET TRIPLE RS, SPEED TRIPLE RS, SPEED TRIPLE S
    Category
    Vehicle
    Distribution
    Distributed nationwide