The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. 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.

13526–13550 of 29188

  • SevereFDA (Devices)·Z-3245-2018·2018-10-03

    Agfa DX-D 600 X-Ray System Recalled for Potential Cable Failure

    Agfa N.V. is recalling 108 DX-D 600 X-ray systems because support cables may break, posing a risk of the equipment falling.

    Product
    DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3265-2018·2018-10-03

    Bausch + Lomb Stellaris Elite Vit Cutter Back Cap Separation Recall

    Bausch & Lomb is recalling Stellaris Elite 20 GA Vit Cutters because the back cap may separate from the body of the device.

    Product
    Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper.
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Devices)·Z-3279-2018·2018-10-03

    GE Medical Systems Recalls Discovery MR750w MRI Systems Due to Burn Risk

    GE Medical Systems is recalling 516 Discovery MR750w MRI systems because a small area on the bore surface can become warm enough to cause a serious burn if a patient touches it without proper padding.

    Product
    Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under: Product Name (Model Number): A. 3.0T MR750 32CH (911000-3); B. 3.0T MR750W (5911000-3, 5481490-2, 5499460-7, 5499460-10, 5373011-3, 5352293, 5911000-3); C.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V682000·2018-10-01

    Winnebago Recalls Minnie Drop Trailers Due to Propane Line Fire Risk

    Winnebago is recalling 2017-2019 Minnie Drop trailers because a missing clamp may allow the propane line to contact the refrigerator burner, posing a fire risk.

    Product
    WINNEBAGO — WINNEBAGO MINNIE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V680000·2018-09-28

    BMW Recalls 2019 X6 and X6 M for Rear Suspension Defect

    BMW is recalling 2019 X6 and X6 M vehicles because improperly hardened rear suspension bolts may break, increasing crash risk.

    Product
    BMW — BMW X6, X6 M
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V681000·2018-09-28

    KZRV Sonic Travel Trailer Recall for Propane Manifold Fire Risk

    KZRV is recalling 2017-2019 Sonic 190VRB travel trailers because the liquid propane manifold may be located close to the axle tube, posing a fire risk.

    Product
    KZRV — KZRV SONIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V678000·2018-09-27

    Forest River Recalls 2019 Flagstaff and Rockwood Trailers for Brake Defect

    Forest River is recalling 2019 Flagstaff and Rockwood recreational trailers because incorrectly oriented brake mounting flanges may cause premature brake failure, increasing crash risk.

    Product
    FOREST RIVER — FOREST RIVER FLAGSTAFF, ROCKWOOD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·18235·2018-09-27

    Life Fitness Recalls PowerMill Climbers Due to Fire Hazard

    Life Fitness is recalling about 11,800 PowerMill climbers because liquid entering the power receptacle can cause electrical arcing, sparking, and fire.

    Product
    PowerMill climbers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V661000·2018-09-27

    Honda Recalls Vehicles for Frontal Air Bag Inflator Explosion Risk

    Honda is recalling specific 2010-2015 models because the passenger frontal air bag inflator may explode, potentially causing serious injury or death.

    Product
    HONDA — HONDA, ACURA PILOT, TSX, ACCORD, CR-V
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2972-2018·2018-09-26

    Pro-Med DORO LUCENT Transitional Member Recall for Potential Malfunction

    Pro-Med Instruments is recalling 31 DORO LUCENT Transitional Members because mixing design revisions may cause the headrest system to malfunction.

    Product
    DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-3006-2018·2018-09-26

    Ventana CONFIRM anti-Progesterone Receptor Antibody Recalled for Dispenser Defects

    Ventana Medical Systems is recalling CONFIRM anti-Progesterone Receptor antibodies due to leaking and sticking dispensers that may cause false negative IHC results.

    Product
    CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody, Catalog Number 05278392001, model 790-4296 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2970-2018·2018-09-26

    Pro-Med DORO LUCENT Headrest System Recalled for Malfunction Risk

    Pro-Med Instruments is recalling 30 DORO LUCENT Headrest Systems because mixing design revisions may cause malfunction during surgery.

    Product
    DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries
    Category
    Medical Device
    Distribution
    7 states
  • SevereNHTSA·18V677000·2018-09-26

    Daimler FCCC MC Motorhome Chassis Recall for Air Gauge Line Misconnection

    Daimler Trucks North America is recalling 2017-2019 FCCC MC motorhome chassis because primary and secondary air lines were incorrectly connected to the pressure gauges, increasing crash risk.

    Product
    FCCC — FCCC MC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3194-2018·2018-09-26

    Fresenius 2008T Hemodialysis Systems Recalled for Disinfectant Exposure Risk

    Fresenius Medical Care is recalling 80 hemodialysis systems because a power failure during cleaning may allow disinfectant to remain in the machine and be delivered to patients.

    Product
    2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1193-2018·2018-09-26

    Beaumont Bio-Med Recalls Sinus Response Homeopathic Formula Due to CGMP Deviations

    Beaumont Bio-Med, Inc. is recalling 90 bottles of Sinus Response Homeopathic Formula due to manufacturing deviations that could result in microbial contamination.

    Product
    Sinus Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7013-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V670000·2018-09-26

    Nova Bus Recalls 2017 LFS Hybrid Buses for Transmission Defect

    Nova Bus is recalling 2017 LFS Hybrid and LFS Arctic Hybrid buses because pressure switches may fail, causing a loss of drive and increasing crash risk.

    Product
    NOVA BUS — NOVA BUS LFS, LFS ARTIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2999-2018·2018-09-26

    Ventana Medical Systems Recalls ultraView SISH DNP Detection Kit Due to Leaking

    Ventana Medical Systems is recalling 96 units of the ultraView SISH DNP Detection Kit because leaking and sticking dispensers may cause false negative IHC results.

    Product
    ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-098 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1968-2018·2018-09-26

    Campomex USA Fresh Cilantro Recalled Due to Cyclospora Contamination

    Campomex USA is recalling fresh cilantro found positive for Cyclospora. The product was distributed in California after being mistakenly released from import hold.

    Product
    Campomex USA fresh cilantro: 5 dozens (60) per box.
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·18V666000·2018-09-25

    Kia Recalls 2017-2018 Niro Hybrids for Fire Risk

    Kia is recalling 2017-2018 Niro hybrid vehicles because a faulty relay may overheat the rear seat, increasing the risk of a fire.

    Product
    KIA — KIA NIRO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·18230·2018-09-25

    Traeger Recalls Scout and Ranger Grills Due to Fire Hazard

    Traeger Grills is recalling Scout and Ranger portable wood pellet grills because grease can leak from the drip tray, posing a fire hazard.

    Product
    Scout and Ranger portable wood pellet grills
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V667000·2018-09-25

    Suzuki Recalls 2006 Grand Vitara for Power Steering Belt Tensioner Defect

    Suzuki is recalling 2006 Grand Vitara vehicles because a plastic component in the power steering system can deteriorate, potentially causing a loss of steering assist and increasing crash risk.

    Product
    SUZUKI — SUZUKI GRAND VITARA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V669000·2018-09-25

    Maintainer Service Mechanic Bodies Recalled for Driveshaft Interference Risk

    Maintainer is recalling 2017-2018 Service Mechanic Bodies mounted on Ford F-Series Super Duty trucks because a hydraulic pump may interfere with the front axle driveshaft, potentially causing separation and increasing crash risk.

    Product
    MAINTAINER — MAINTAINER SERVICE/MECHANICBODY FORD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V668000·2018-09-25

    Volvo Recalls VNL Trucks Due to Fuel Line Burst Risk

    Volvo is recalling 2016-2019 VNL trucks with Cummins ISX15 engines because a restricted fuel pump cooling circuit screen may cause the fuel line to burst.

    Product
    VOLVO — VOLVO VNL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V658000·2018-09-24

    Grand Design Recalls 2019 Travel Trailers Due to Axle Bearing Defect

    Grand Design is recalling 2019 Reflection, Imagine, and Transcend travel trailers because missing inner axle bearings may cause overheating and fire.

    Product
    GRAND DESIGN — GRAND DESIGN TRANSCEND, REFLECTION, IMAGINE
    Category
    Vehicle
    Distribution
    Distributed nationwide