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.

30801–30825 of 50502

  • HighNHTSA·17V582000·2017-09-20

    Double K Recalls 2016-2017 Hometown Trolley Buses for Seat Belt Defect

    Double K is recalling 2016-2017 Hometown Trolley buses because the seat belt buckle may be stuck in the locked position, preventing the belt from latching.

    Product
    HOMETOWN TROLLEY — HOMETOWN TROLLEY STREETCAR, MAINSTREET, VILLAGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2870-2017·2017-09-20

    X-Laser High-Power Laser Projectors Recalled for Safety Standard Non-Compliance

    X-Laser is recalling 830 high-power laser light show projectors because they fail to meet federal performance standards when used in auto and music modes.

    Product
    X-Laser Laser Light Show projector models Aurora, Caliente Aurora, PSX-400, Mobile Beat Max, Mobile Beat Max MKII, X-Beam, Hawk 500 High-power laser light show projector.
    Category
    Consumer Product
    Distribution
    0 states
  • HighCPSC·17228·2017-09-20

    DEMDACO Recalls Infant Bib and Bootie Sets Due to Choking Hazard

    DEMDACO is recalling about 1,500 infant bib and bootie sets because rattle attachments can detach, posing a choking hazard. No injuries have been reported.

    Product
    Infant bib and bootie sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3117-2017·2017-09-20

    Zimmer Biomet Recalls ROSA Surgical Device Foot Switches

    Zimmer Biomet is recalling 64 ROSA surgical device foot switches that may freeze or shut down during use.

    Product
    Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model 2.5.8. The firm name on the foot switch label is Herga Electric Limited, Bury, St. Edmunds, Suffolk IP32 6NN. ROSA Surgical Device is a computer-controlled…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3543-2017·2017-09-20

    Wegmans Assorted Muffins Recalled for Unlabeled Walnut Allergen

    Wegmans is recalling Assorted Muffins 4-Packs because they may contain walnuts that are not listed on the ingredient label.

    Product
    Wegmans Assorted Muffins 4-Pack-18 oz. (1 lb. 2 oz.) 510g packaged in clear plastic shell. UPC: 77890-22744 .
    Category
    Food
    Distribution
    6 states
  • HighNHTSA·17V584000·2017-09-20

    Fleetwood Recalls 2013-2016 RVs Due to Battery Tray Weld Defect

    REV Recreation Group is recalling 2013-2016 Fleetwood Bounder and Southwind RVs because insufficient battery tray welds may cause the tray to separate, risking fire or injury.

    Product
    FLEETWOOD — FLEETWOOD BOUNDER, SOUTHWIND
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17227·2017-09-20

    John Deere Recalls D105 Lawn Tractors Due to Transmission Crash Hazard

    John Deere is recalling D105 lawn tractors and service transmissions because the transmission can fail, posing a crash hazard. No injuries have been reported.

    Product
    John Deere D105 lawn tractors and service part transmissions
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3541-2017·2017-09-20

    Tomanetti Pizza Crusts Recalled for Flexible Plastic Contamination

    Tomanetti Food Products is recalling 12-inch homestyle pizza crusts after a consumer complaint reported small pieces of flexible plastic in the product.

    Product
    12" homestyle pizza crusts packed 18 to a case (no consumer packaging) labeled as: Tomanetti Pizza Crusts with the 18-12" Homestyle 9111 block checked.; Keep Frozen; Pizza Crusts; Tomanetti Food Products, 625 Allegheny Avenue, Oakmont, PA 15139 stamped with code: Manufactured…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-3542-2017·2017-09-20

    Zlotoklos Butter Cookies Recalled for Undeclared Milk Allergen

    Zlotoklos brand butter cookies are being recalled because the packaging lists butter but fails to identify milk as the source, violating FALCPA requirements.

    Product
    Zlotoklos brand Ciastka maslane w czekoladzie (Butter cookies in chocolate), 12.3 oz (350 g). Product is packaged in a plastic tray with foil overwrap, 12 packages per case.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-3133-2017·2017-09-20

    Baxter Amia Automated Peritoneal Dialysis Set Recalled for Flow Issues

    Baxter Healthcare is recalling 164,700 units of Amia Automated Peritoneal Dialysis Sets due to increased customer complaints regarding flow and drain alerts.

    Product
    Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3127-2017·2017-09-20

    Orthofix Firebird NXG Decorticating Planer Recalled for Missing Plastic Core

    Orthofix is recalling six Firebird NXG Spinal Fixation System Decorticating Planers because the plastic core was found missing, which could cause scoring of the bone screw neck.

    Product
    Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx. .A Decorticating Planer is used to decorticate bone surrounding the spherical head of an implanted bone screw in order to provide clearance to allow for proper seating of the modular…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-3130-2017·2017-09-20

    Mako Surgical Recalls Robotic Knee System Due to Software Display Error

    Mako Surgical Corporation is recalling the Makoplasty Partial Knee Application software because it may fail to display all necessary constants when the screen is full.

    Product
    Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·17V574000·2017-09-19

    Mercedes-Benz Recalls Four 2017 Models for Steering Defect

    Mercedes-Benz is recalling four 2017 vehicles due to improperly welded steering pins that may disable power assist, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ E300, AMG E43, GLC300, AMG C43
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V567000·2017-09-14

    GM Recalls 2017-2018 Silverado and Sierra Trucks for Seat Belt Defect

    General Motors is recalling 2017-2018 Chevrolet Silverado and GMC Sierra trucks because front seat belt retractors may not perform correctly in a crash.

    Product
    GMC — GMC, CHEVROLET SIERRA 3500, SIERRA 2500, SILVERADO 3500, SILVERADO 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3113-2017·2017-09-13

    Beckman Coulter Hematology Analyzers Recalled for Potential Blast Detection Failure

    Beckman Coulter is recalling LH 750, LH 780, and LH 500 analyzers because they may fail to flag blasts in some blood samples.

    Product
    Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Analyzers are quantitative, automated hematology analyzers and leukocyte differential counters For In Vitro Diagnostic used in clinical laboratories. They also provide automated Reticulocyte analysis and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3107-2017·2017-09-13

    Cardinal Health Recalls Presource Kits Contaminated with Needle Particulate

    Cardinal Health is recalling Presource surgical kits because they contained BD SafetyGlide needles with loose polypropylene particulate in the fluid path.

    Product
    Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific disposable class I, II, and II implantable, life-supporting, or life-sustaining devices required by customers for common surgical and other medical procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·17V564000·2017-09-13

    Heartland Recalls 2018 Sundance XLT TT Trailers Due to Axle Defect

    Heartland is recalling 2018 Sundance XLT TT recreational trailers because rear axles were installed backwards, which may reduce braking ability or cause brakes to lock up.

    Product
    HEARTLAND — HEARTLAND SUNDANCE XLT TT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3103-2017·2017-09-13

    MicroVention Traxcess 7 Mini Guidewire Recalled for Coating Delamination

    MicroVention is recalling 34 units of Traxcess 7 Mini Guidewires because the hydrophilic coating may delaminate from the device.

    Product
    MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-3114-2017·2017-09-13

    Beckman Coulter HmX Analyzers Recalled for Potential Blast Detection Failure

    Beckman Coulter is recalling HmX CP and HmX AL analyzers because they may fail to flag or detect blasts in rare blood sample situations.

    Product
    Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies. These studies include further measurements of cell size and cell…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3105-2017·2017-09-13

    Merge Unity Software Recall for Incorrect Gail Risk Calculations

    Merge Healthcare is recalling Merge Unity software versions 10.0 through 11.1.2 Patch 4 because the software fails to identify atypical hyperplasia, leading to incorrect Gail Risk calculations.

    Product
    Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3112-2017·2017-09-13

    Qualigen Vitamin D Immunoassay Kit Recalled for Inaccurate Test Results

    Qualigen Inc is recalling specific lots of its Vitamin D Complete Immunoassay Kit because they may produce falsely low results.

    Product
    Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3104-2017·2017-09-13

    Stanmore JTS Distal Femoral Implant Recalled Due to Extension Failure

    Stanmore Implants Worldwide Ltd. is recalling 15 JTS Distal Femoral Extendible Implants because they may fail to extend as intended due to incorrect orientation or settings.

    Product
    JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.
    Category
    Medical Device
    Distribution
    10 states
  • HighNHTSA·17V562000·2017-09-12

    RAM Trucks Recalled for Water Pump Leak Fire Risk

    Chrysler is recalling 2013-2017 RAM trucks with specific Cummins diesel engines because a water pump defect may leak coolant and increase the risk of an engine compartment fire.

    Product
    RAM — RAM 3500, 5500, 4500, 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide