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.

36726–36750 of 50504

  • HighFDA (Devices)·Z-0719-2016·2016-02-10

    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 mistaken for live images.

    Product
    INTEGRIS BN/BV3000; Model Number: 72240 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-0713-2016·2016-02-10

    Philips Allura Xper FD20/20 Recall for Image Interpretation Error

    Philips is recalling 13,297 Allura Xper FD20/20 systems because a software issue may cause still images to be mistaken for live images during medical procedures.

    Product
    Allura Xper FD20/20; Model Number: 722038 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
  • HighFDA (Devices)·Z-0708-2016·2016-02-10

    Philips UNIQ and Allura Systems Recalled for Image Interpretation Error

    Philips is recalling UNIQ and Allura imaging systems because still images may be misinterpreted as live images during medical procedures.

    Product
    UNIQ FD; Model Numbers: 722028 The Philips UNIQ is intended for use on human patients to perform: " Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0729-2016·2016-02-10

    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.

    Product
    INTEGRIS CV; Model Number: 722030 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 interventional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0725-2016·2016-02-10

    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 BV5000: Model Number: 72249 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-0723-2016·2016-02-10

    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 BH5000; Model Number: 72247 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 (Food)·F-0510-2016·2016-02-10

    This Kid Saves Lives Chocolate Chip Bars Recalled for Undeclared Milk

    This Bar Saves Lives is recalling This Kid Saves Lives Chocolate Chip bars because they contain whey protein but do not identify milk on the label.

    Product
    This Kid Saves Lives Chocolate Chip UPC #10858497004097 UPC# 858497004090
    Category
    Food
    Distribution
    28 states
  • HighFDA (Devices)·Z-0701-2016·2016-02-10

    Mindray Recalls Panorama Patient Monitoring Network Software Due to Restart Issue

    Mindray is recalling Panorama Patient Monitoring Network software kits because the system may spontaneously restart, causing a temporary loss of monitoring.

    Product
    Panorama Patient Monitoring Network. Software Kit 0020-00-0205-19A, View Station Software Kit 0020-00-0206-16A, Work Station Software Kit 0020-00-0207-16A, Software Kit Upgrade TECH-00-910. The Panaroma Patient Monitoring Network is intended for use in a fixed location in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0717-2016·2016-02-10

    Philips INTEGRIS and Allura Systems Recalled for Image Display Error

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

    Product
    INTEGRIS H3000; Model Number: 72238 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 interventional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0722-2016·2016-02-10

    Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Risk

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

    Product
    INTEGRIS H5000; Model Number: 72246 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 interventional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0741-2016·2016-02-10

    Horiba ABX PENTRA Lactic Acid Reagent Recalled for Interference

    Horiba Instruments Inc. is recalling ABX PENTRA Lactic Acid CP reagents because N-acetylcysteine in patient blood can cause falsely low results.

    Product
    ABX PENTRA Lactic Acid CP ref. A11A01721 reagent is intended for the quantitative in vitro diagnostic determination of lactic acid in plasma by colorimetry. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis…
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0733-2016·2016-02-10

    Owens & Minor Recalls MediChoice Cohesive Bandages Due to Microbial Contamination

    Owens & Minor is recalling MediChoice sterile cohesive bandages because testing revealed microbial contamination. The affected products were distributed nationwide.

    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
  • HighNHTSA·16E011000·2016-02-09

    Haier Recalls 55-Inch LED Televisions in Fifth-Wheel Recreational Vehicles

    Haier is recalling 55-inch LED televisions installed in fifth-wheel recreational vehicles because mounting brackets may separate, causing the TVs to fall.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V065000·2016-02-05

    Toyota and Lexus Vehicles Recalled for Side Air Bag Defect

    Toyota is recalling specific 2003-2006 Land Cruiser, LX470, Tundra, Sequoia, 4Runner, and GX470 vehicles because side air bags may deploy unexpectedly, increasing injury risk.

    Product
    LEXUS — LEXUS, TOYOTA LX470, GX470, 4RUNNER, LAND CRUISER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V070000·2016-02-05

    Kia Recalls 2011 Fortes for Transmission Fluid Leak Risk

    Kia is recalling 2011 Fortes because a defective transmission cooler hose may leak fluid, potentially causing the vehicle to stop moving and increasing crash risk.

    Product
    KIA — KIA FORTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16095·2016-02-04

    Wedgwood Decorative Baby Rattles Recalled Due to Choking Hazard

    WWRD is recalling Wedgwood Peter Rabbit decorative baby rattles because ball bearings can release, posing a choking hazard to young children.

    Product
    Wedgwood Peter Rabbit decorative baby rattles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16E010000·2016-02-04

    Helmet City Recalls Model 115 Helmets Due to Strap Stretching

    Helmet City, Inc. is recalling 270 Model 115 German helmets, size XL, because the straps may stretch excessively during a crash, failing to keep the helmet secured.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide