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.

40051–40075 of 50506

  • HighFDA (Devices)·Z-0227-2015·2014-11-26

    Monteris Medical Recalls SideFire Directional Laser Probes Due to Tip Separation

    Monteris Medical is recalling 234 SideFire Directional Laser Probes because the distal sapphire tip may separate from the probe.

    Product
    SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal…
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1581-2014·2014-11-26

    Medtronic Recalls Disposable Surgical Devices Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 single-use disposable devices because returned items were not adequately inspected for damage that could compromise sterility.

    Product
    DISP 9730950 STRL SPHERE, 1 PK INSERT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0219-2015·2014-11-26

    Synthes Recalls Titanium Trochanteric Fixation Nails Due to Assembly Error

    Synthes, Inc. is recalling six sterile titanium trochanteric fixation nails due to incorrect assembly that may compromise bone stability.

    Product
    10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0228-2015·2014-11-26

    Monteris Medical Recalls FullFire Diffusing Tip Laser Probes Due to Tip Separation

    Monteris Medical is recalling 133 FullFire Diffusing Tip Laser Probes because the distal sapphire tip may separate from the probe.

    Product
    FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal…
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0225-2015·2014-11-26

    Medacta MectaLIF Oblique Handle Recalled for Incorrect Laser Marking

    Medacta USA is recalling 32 MectaLIF Oblique Handles because incorrect laser markings could lead to improper device insertion during surgery.

    Product
    The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1583-2014·2014-11-26

    Medtronic Recalls Sterile O-Arm Drapes Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 sterile O-Arm drapes because returned devices were not adequately examined for damage to ensure sterility.

    Product
    DRAPE 9732722 TUBE STERILE O-ARM 20PK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1591-2014·2014-11-26

    Medtronic Recalls Patient Tracker Devices Due to Sterility Control Issues

    Medtronic Navigation is recalling single-use Patient Tracker devices because returned units may not have been properly examined for damage to ensure sterility.

    Product
    PATIENT TRACKER 9733534XOM ENT 1PK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14V753000·2014-11-25

    Aston Martin Recalls 2006-2014 Models for Seat Heater Overheating Risk

    Aston Martin is recalling 7,256 vehicles because a faulty seat heater module may prevent the heaters from turning off, creating a risk of overheating and injury.

    Product
    ASTON MARTIN — ASTON MARTIN V8 VANTAGE, DBS, DB9, V12 VANTAGE COUPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15037·2014-11-25

    Pro Armor Recalls Utility Vehicle Doors Due to Latch Failure

    Pro Armor is recalling about 300 utility vehicle doors for Polaris RZR models because the latch pin can disengage, posing impact and laceration hazards.

    Product
    Utility vehicle doors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V748000·2014-11-24

    Champion Transit Bus Recall for Defective Passenger Seat Spring Nuts

    Champion is recalling 2014-2015 transit buses because defective spring nuts may fail to secure passenger seats, increasing injury risk in a crash.

    Product
    CHAMPION — CHAMPION DEFENDER, CRUSADER, CHALLENGER, LF TRANSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V745000·2014-11-21

    Altec Recalls Aerial Devices Due to Hydraulic Pressure Transducer Defect

    Altec is recalling 1999-2014 aerial devices because an improperly set hydraulic pressure transducer may cause inadvertent boom movement in cooler temperatures, increasing injury risk.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15709·2014-11-20

    Tyco Recalls Simplex Fire Alarm Panels Due to Activation Failure

    Tyco is recalling about 750 Simplex 4100ES fire alarm control panels because a defective chip can prevent the system from activating during an alarm, posing a risk of injury and property damage.

    Product
    Simplex 4100ES Fire Alarm Control Panel
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·15035·2014-11-20

    Leatherman Recalls Children's Multi-Tool Due to Laceration Hazard

    Leatherman is recalling the Leap multi-tool because the optional knife blade can inadvertently release, posing a laceration hazard. No injuries have been reported.

    Product
    Leatherman® Leap™ multi-tool
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·15708·2014-11-20

    Bob-Cat Recalls Zero Turn Riding Mowers Due to Crash Hazard

    Bob-Cat is recalling about 4,900 zero turn riding mowers because the steering control arm can break, causing the driver to lose control and crash.

    Product
    Bob-Cat Zero Turn Riding Mower
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V741000·2014-11-19

    Jaguar Recalls 2014-2015 XJ Models for Brake Line Leak Risk

    Jaguar is recalling 2014-2015 XJ vehicles because brake line junctions may leak fluid, potentially reducing braking ability and increasing crash risk.

    Product
    JAGUAR — JAGUAR XJ
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0501-2015·2014-11-19

    Mondelez Recalls Chiclets Fruit Gum for Undeclared Soy Lecithin

    Mondelez Global LLC is voluntarily recalling specific packages of Chiclets Fruit Flavor Gum because the label fails to declare soy lecithin.

    Product
    1) Chiclets Fruit Flavor Gum, 12 piece, Retail UPC 0 12546 10628 3; 2) Chiclets Fruit Flavor Gum, 20 - 12 piece packages (240 pieces), Retail UPC 0 12546 02503 4, Case UPC 10012
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0196-2015·2014-11-19

    Steris 5085 Surgical Tables Recalled for Damaged Column Shrouds

    Steris is recalling 5085 and 5085SRT surgical tables because column shrouds may become damaged, potentially preventing the table from raising or lowering.

    Product
    The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation.
    Category
    Medical Device
    Distribution
    36 states
  • HighNHTSA·14V742000·2014-11-19

    Champion Transit Buses Recalled for Wheelchair Lift Platform Cracking Risk

    Champion Bus is recalling 2006-2014 transit buses equipped with certain Ricon wheelchair lifts because the platform side plate may crack, posing an injury risk.

    Product
    CHAMPION — CHAMPION HCAC, STACKED RAIL, PLATINUM SHUTTLE, DEFENDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15031·2014-11-19

    Mohawk Recalls Altitude Gold Shag Rugs Due to Fire Hazard

    Mohawk Industries is recalling Altitude Gold shag rugs sold at The Home Depot because large sizes fail federal flammability standards, posing fire and burn risks.

    Product
    Altitude Gold shag rugs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0209-2015·2014-11-19

    American Medical Systems Recalls AMS 700 Series Inflatable Penile Prosthesis Accessory Kits

    American Medical Systems is recalling AMS 700 Series Accessory Kits because supplier-supplied Keith needles may bend or break when used with the Furlow tool.

    Product
    AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850. Keith Needles are part of the AMS 700 Accessory Kit. In conjunction with the Furlow Insertion Tool (Furlow), the Keith Needles facilitate the passing of the pulling sutures…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·15029·2014-11-19

    Olympus Recalls Digital Audio Recovers Due to Overheating Burn Hazard

    Olympus is recalling DS-5500 digital audio recorders because they can overheat while charging, posing a burn hazard to consumers and property.

    Product
    Olympus DS-5500 digital audio recorders
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0503-2015·2014-11-19

    Chiclets Gum Recalled for Undeclared Soy Lecithin

    Mondelez Global LLC is voluntarily recalling Chiclets Gum because the label fails to declare soy lecithin, a common allergen.

    Product
    Chiclets Gum, 200 - 2 piece packs (400 pieces), Retail UPC 0 12546 02509 6, Case UPC 10012546108499
    Category
    Food
    Distribution
    Distributed nationwide