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.

36676–36700 of 50504

  • HighFDA (Devices)·Z-0791-2016·2016-02-17

    Richard Wolf Reusable Rotary Blade Recalled for Weak Welds

    Richard Wolf Medical Instruments Corp. is recalling two reusable rotary blades due to weak welds that may cause the product to break during surgical use.

    Product
    Reuseable rotary blade/abrader, product number 899751514. The oval burr frontally hooded is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0771-2016·2016-02-17

    Accuray CyberKnife Robotic Recall for Potential Gun Box Mounting Bracket Failure

    Accuray is recalling CyberKnife Robotic systems because the gun box mounting bracket may fail, allowing the gun box to fall and contact a patient.

    Product
    CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0761-2016·2016-02-17

    Del Medical VS200 Radiographic Cassette Holder Recall for Falling Hazard

    Del Medical is recalling VS200 radiographic cassette holders and wall stands because they can suddenly fall to the ground and contact patients.

    Product
    VS200 radiographic Cassette Holder or Wall Stand. For use in radiology department.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0763-2016·2016-02-17

    GE Medical Systems Recalls Mavig Monitor Suspension System Due to Fall Risk

    GE Medical Systems is recalling 2,111 Mavig Monitor Suspension Systems because a reported incident involved a suspension arm falling to the floor.

    Product
    Mavig Monitor Suspension System, Model GD60, contained in the following Fluoroscopic imaging systems: Advantx LCV+, Advantx LCN+, Advantx LCLP+, Advantx LCA, INNOVA 2000, INNOVA 4100, INNOVA 3100, INNOVA 3131IQ, INNOVA 2121IQ, INNOVA 2100IQ, INNOVA 3100IQ, and INNOVA 4100IQ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0762-2016·2016-02-17

    Del Medical VS300 Radiographic Cassette Holder Recall for Falling Hazard

    Del Medical, Inc. is recalling VS300 radiographic cassette holders and wall stands because the unit can suddenly fall to the bottom of its travel and contact a patient.

    Product
    VS300 radiographic Cassette Holder or Wall Stand. For use in radiology department.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0559-2016·2016-02-17

    Signature Kitchens Hot Dog Buns Recalled for Foreign Material

    Albertsons is recalling Signature Kitchens Enriched Hot Dog Buns because cloth material from production equipment may be present in the product.

    Product
    Signature Kitchens Enriched Hot Dog; 8 buns; NET WT 12 oz 340 g UPC 0 21130 18501 6; Distributed by Living Better Brands, LLC, Pleasanton, CA 94566 Contains: Wheat May Contain eggs, milk.
    Category
    Food
    Distribution
    3 states
  • HighNHTSA·16V086000·2016-02-16

    Starcraft AR-One Toy Hauler Recall for Incorrect Tire Labels

    Starcraft is recalling 2016 AR-One toy hauler trailers because incorrect tire labels may lead to improper tire replacement, increasing crash risk.

    Product
    STARCRAFT RV TT — STARCRAFT RV TT AR-ONE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V087000·2016-02-16

    Mercedes-Benz Recalls 2016 C300 and C450 Models for Sunroof Defect

    Mercedes-Benz is recalling specific 2016 C300 and C450 vehicles because the panoramic sunroof glass may not be properly bonded and could detach during operation.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ C300, C450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V088000·2016-02-16

    IMT Recalls Dominator Cranes Due to Valve Bank Cover Defect

    Iowa Mold Tooling is recalling 2013-2016 Dominator vehicles because a valve bank cover may crack and fall off, creating a road hazard.

    Product
    IMT — IMT DOMINATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16101·2016-02-12

    Crescent Point Energy Recalls Propane Gas Due to Fire and Burn Hazards

    Crescent Point Energy is recalling approximately 118 million gallons of propane gas in the U.S. because insufficient odorant levels may prevent consumers from detecting leaks, posing fire and burn risks.

    Product
    Propane (LP) Gas
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V084000·2016-02-11

    GM Recalls 2016 Vehicles for Missing Audio Safety Warnings

    General Motors is recalling 2016 Chevrolet and GMC vehicles because the radio may fail to provide audio warnings for unbelted drivers or keys left in the ignition.

    Product
    GMC — GMC, CHEVROLET SIERRA, SILVERADO, MALIBU, CAMARO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V082000·2016-02-11

    Starcraft RV Recalls 2016 Trailers Due to Water Heater Overheating Risk

    Starcraft RV is recalling 2016 Solstice and Travel Star trailers because water heaters may overheat, posing a scalding risk.

    Product
    STARCRAFT RV FW — STARCRAFT RV FW, STARCRAFT RV TT SOLSTICE, TRAVEL STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0710-2016·2016-02-10

    Philips Allura Xper OR Table Recall for Image Interpretation Risk

    Philips is recalling Allura Xper FD20 OR Tables because live and still images may be misinterpreted, potentially affecting diagnostic accuracy.

    Product
    Allura Xper FD20 OR Table; Model Numbers: 722035 722023 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0720-2016·2016-02-10

    Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error

    Philips is recalling INTEGRIS and Allura medical imaging systems because a software issue may cause still images to be misinterpreted as live images.

    Product
    INTEGRIS BH3000; Model Number: 72242 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0707-2016·2016-02-10

    Philips Allura Xper FD20 Recall for Image Interpretation Error

    Philips is recalling Allura Xper FD20 systems because still images may be misinterpreted as live images, potentially affecting diagnostic accuracy.

    Product
    Allura Xper FD20; Model Numbers: 722028 722012 722006 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0756-2016·2016-02-10

    BioMerieux Recalls API ZYM Bx2 Reagent Due to False Negative Results

    BioMerieux SA is recalling API ZYM Bx2 reagent because it produces false negative results, leading to discrepant identification outcomes in laboratory tests.

    Product
    API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test used for revealing the results of some miniaturized biochemical test including in the involved API strips.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0735-2016·2016-02-10

    MediChoice Cohesive Bandages Recalled for Microbial Contamination

    Owens & Minor is recalling MediChoice sterile cohesive bandages because testing revealed microbial contamination.

    Product
    MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging] General Hospital Use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0712-2016·2016-02-10

    Philips Allura Xper Biplane OR Table Recall for Image Interpretation Error

    Philips is recalling Allura Xper FD20 Biplane OR Tables because still images may be incorrectly interpreted as live images during use.

    Product
    Allura Xper FD20 Biplane OR Table; Model Numbers: 722025 722020 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0718-2016·2016-02-10

    Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error

    Philips is recalling INTEGRIS and Allura systems because a software issue may cause still images to be mistaken for live images during procedures.

    Product
    INTEGRIS HM3000; Model Number: 72239 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0715-2016·2016-02-10

    Philips Allura Medical Imaging Systems Recalled for Image Interpretation Error

    Philips is recalling Allura CV20 systems because a software issue may cause still images to be mistaken for live images during medical procedures.

    Product
    Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are qualified to perform medical procedures on humans (having a maximum weight of 250…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0714-2016·2016-02-10

    Philips Allura Xper OR Table Recalled for Image Interpretation Error

    Philips is recalling Allura Xper OR Tables because still images may be mistaken for live images, potentially affecting diagnostic accuracy.

    Product
    Allura Xper FD20/20 OR Table; Model Number: 722039 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0706-2016·2016-02-10

    Philips Allura Xper FD20/15 Recall for Image Display Error

    Philips is recalling 13,297 Allura Xper FD20/15 systems worldwide because a software error may cause still images to be interpreted as live images.

    Product
    Allura Xper FD20/15; Model Numbers: 722058 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements…
    Category
    Medical Device
    Distribution
    Distributed nationwide