The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

38501–38525 of 50506

  • HighFDA (Devices)·Z-1777-2015·2015-06-17

    Philips Medical Systems Recalls Forte-JetStream AZ UPS Accessory Devices

    Philips Medical Systems is recalling 11 Forte-JetStream AZ UPS accessory devices used in CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fumes.

    Product
    Forte-JetStream AZ (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1751-2015·2015-06-17

    HeartWare HVAD Recall Issued for Discolored and Cracked Driveline Outer Sheath

    HeartWare Inc is recalling HVAD systems due to complaints of discolored and cracked driveline outer sheaths. The recall affects 3,747 units currently in use.

    Product
    HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-1790-2015·2015-06-17

    Philips BrightView X UPS Accessory Devices Recalled for Battery Acid Leakage

    Philips Medical Systems is recalling 108 BrightView X UPS accessory devices used with CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fume emission.

    Product
    BrightView X (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1771-2015·2015-06-17

    Philips Medical Systems Recalls Ingenuity Core UPS Accessory Devices

    Philips Medical Systems is recalling 215 Ingenuity Core UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.

    Product
    Ingenuity Core (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1722-2015·2015-06-17

    Vilex FUZE Ankle Arthrodesis Screws Recalled for Breakage

    Vilex, Inc. is recalling FUZE 10.0 mm x 200 mm ankle arthrodesis screws because the incidence of breakage is higher than expected.

    Product
    Vilex, Inc., FUZE 10.0 mm x 200 mm, Product # FZ100-200T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1714-2015·2015-06-17

    ASP Recalls EVOTECH Endoscope Cleaner for Connection Detection Failure

    Advanced Sterilization Products is recalling EVOTECH Endoscope Cleaner and Reprocessor units because they may fail to detect disconnected endoscopes, allowing the cleaning cycle to complete without proper processing.

    Product
    EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to achieve…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1763-2015·2015-06-17

    Philips Brilliance CT 40 Uninterruptible Power Supply Recall

    Philips is recalling Brilliance CT 40 Uninterruptible Power Supply accessories due to risks of battery acid leakage, overheating, and fume emission.

    Product
    Brilliance CT 40 - Slices(Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1788-2015·2015-06-17

    Philips Recalls GEMINI TF Ready UPS Accessory Devices for CT Systems

    Philips Medical Systems is recalling three GEMINI TF Ready UPS accessory devices used with CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fumes.

    Product
    GEMINI TF Ready (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1758-2015·2015-06-17

    Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device Recalled for Potential Damage

    Edwards Lifesciences is recalling IntraClude Intra-Aortic Occlusion Devices due to potential damage near the hub that may cause blood leakage.

    Product
    Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System. Packaged sterile and non-pyrogenic in a sealed, peel-type pouch For use in patients undergoing cardiopulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1719-2015·2015-06-17

    Elekta Recalls Leksell GammaPlan Software Due to Memory Corruption

    Elekta is recalling 10 units of Leksell GammaPlan 10.2 software because memory can become corrupted when creating a fused study via drag and drop.

    Product
    Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1768-2015·2015-06-17

    Philips Brilliance iCT UPS Accessory Devices Recalled for Battery Acid Leakage

    Philips Medical Systems is recalling Brilliance iCT UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.

    Product
    Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1774-2015·2015-06-17

    Philips FORTE UPS Accessory Devices Recalled for Battery Acid Leakage Risk

    Philips Medical Systems is recalling 10 FORTE Uninterruptible Power Supply (UPS) accessory devices used with CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fume emission.

    Product
    FORTE (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1741-2015·2015-06-17

    Biomet Recalls Unilateral External Fixation Ankle Clamps Due to Assembly Error

    Biomet, Inc. is recalling 19 unilateral external fixation ankle clamps because they were assembled incorrectly. The defect may prevent full range of motion and cause the pin to loosen from the bone.

    Product
    Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone conditions amenable to treatment by use of external fixation modality
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·15165·2015-06-16

    Bunnies by the Bay Recalls Pull Toys Due to Choking Hazard

    Bunnies by the Bay is recalling Bud and Skipit Wheely Cute Pull Toys because wheel hub caps can break off, posing a choking hazard to young children.

    Product
    Bud and Skipit Wheely Cute Pull Toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·092-2015·2015-06-16

    Venus Foods Recalls Pork Sausage for Undeclared Wheat Allergen

    Venus Foods Inc. is recalling approximately 25,380 pounds of pork sausage products because they contain wheat, a known allergen, that is not declared on the label.

    Product
    Venus Foods Inc. — Venus Foods Inc Recalls Pork Sausage Products Due to Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·15V377000·2015-06-16

    EverGreen Recalls Fifth Wheel Trailers Due to Step Rivet Failure Risk

    EverGreen is recalling 2014-2016 fifth wheel trailers because a rivet on the entry steps may shear, causing the steps to give and increasing the risk of injury.

    Product
    EVERGREEN — EVERGREEN LIFESTYLE, ALPHA GOLD, BAY HILL, TESLA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V374000·2015-06-15

    New Horizons Recalls 2013-2015 Summit and Majestic RVs for Step Defect

    New Horizons is recalling 2013-2015 Summit and Majestic RVs because a rivet on the quad entry steps may fail, causing the steps to give and increasing the risk of injury.

    Product
    NEW HORIZONS — NEW HORIZONS SUMMIT, MAJESTIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15E051000·2015-06-15

    Alcoa Recalls 22.5-Inch Aluminum Wheels Due to Forging Defect

    Alcoa is recalling specific 22.5-inch aluminum wheels manufactured in April and May 2015 because a forging defect may cause the rim flange to separate during tire mounting.

    Product
    WHEELS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15E049000·2015-06-12

    Yakima Recalls Q-Tower Roof Racks Due to Loose Fit Risk

    Yakima is recalling specific Q-Tower Roof Racks and replacement towers because clamping wedges may slide, causing a loose fit that could eject the rack while driving.

    Product
    EQUIPMENT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15V366000·2015-06-12

    Subaru Recalls 2015-2016 Models for Driver Assist System Defect

    Subaru is recalling specific 2015-2016 models because a faulty switch may prevent the automatic pre-collision braking system from functioning, increasing crash risk.

    Product
    SUBARU — SUBARU XV CROSSTREK, OUTBACK, LEGACY, WRX
    Category
    Vehicle
    Distribution
    Distributed nationwide