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.

33801–33825 of 50502

  • HighFDA (Devices)·Z-0645-2017·2016-11-30

    DiaSorin Recalls LIAISON Estradiol II Gen Assay Due to Cross-Reactivity

    DiaSorin is recalling the LIAISON Estradiol II Gen assay because it may produce inaccurate results for patients treated with fulvestrant.

    Product
    LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent immunoassay (CLIA) intended for the quantitative determination of estradiol in human serum. Assay results should be used in conjunction with other clinical and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0376-2017·2016-11-30

    Philips CT Scanner Recall Due to Potential Tabletop Movement Failure

    Philips is recalling 1,363 CT scanners because the patient support tabletop may fail to move horizontally during scans due to a mechanical linkage failure.

    Product
    Philips Healthcare System X-ray Tomography Computed :
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0517-2017·2016-11-30

    CSM Bakery Products Recalls Donut Base for Undeclared Peanut Allergen

    CSM Bakery Products NA is recalling BM Westco 1440 Yst Rds Donut Base due to undeclared peanut protein. The product was distributed across 19 states and two territories.

    Product
    BM Westco 1440 Yst Rds Donut Base, 50#
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-0523-2017·2016-11-30

    CSM Bakery Products Recalls White Cake Mix for Undeclared Peanut

    CSM Bakery Products is recalling Brill White Crm Cake Mix because it contains undeclared peanut protein. The product was distributed across 19 states and two territories.

    Product
    Brill White Crm Cake Mix, 50#
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-0623-2017·2016-11-30

    Greatbatch Stiffer Coaxial Micro-Introducer Recalled for Detaching Luer

    Greatbatch Medical is recalling Stiffer Coaxial Micro-Introducers because a rotating luer detached from the dilator hub during use.

    Product
    Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micro-Introducer 4FR; 10904-002 Stiffer Coaxial Micro-Introducer 5FR. The radiopaque Stiffer Coaxial Micro-Introducer (Figure 1) consists of a dilator and sheath, available in 4FR and 5FR.…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0614-2017·2016-11-30

    Merge Healthcare Recalls RadSuite Software Due to Image Display Malfunction

    Merge Healthcare is recalling RadSuite software versions 8.30.7.8 through 8.31 because images may not appear readable, potentially delaying care or causing patient re-exposure to radiation.

    Product
    Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31. Advanced Visualization (Image Viewing) includes: Full featured 2D imaging, 3D surface and volume rendering, Real-time Multi-Planar Reformatting (MPR), Real-time…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0522-2017·2016-11-30

    CSM Bakery Products Recalls Cinnabon Rolls Due to Undeclared Peanut

    CSM Bakery Products is recalling Cinnabon Cinn Rl BS rolls because they contain undeclared peanut protein. The product was distributed to multiple US states and territories.

    Product
    Cinnabon Cinn Rl BS, 50# International
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-0514-2017·2016-11-30

    CSM Bakery Recalls 7-Eleven Spice Cookie Base for Undeclared Peanut

    CSM Bakery Products NA is recalling 7-Eleven Spice Cookie Base because it contains undeclared peanut protein. The product was distributed in multiple states and territories.

    Product
    7-Eleven Spice Cookie Base, 50#
    Category
    Food
    Distribution
    19 states
  • HighCPSC·17038·2016-11-29

    Stanley Commercial Door Locksets Recalled Due to Entrapment Risk

    Stanley is recalling about 70,000 commercial door locksets because the latches can fail, preventing doors from being unlocked from the inside during an emergency.

    Product
    Door locksets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V858000·2016-11-29

    Toyota Recalls 2011-2016 Sienna Minivans for Power Sliding Door Defect

    Toyota is recalling 2011-2016 Sienna minivans because the power sliding door may open unexpectedly while the vehicle is moving, increasing the risk of injury to occupants.

    Product
    TOYOTA — TOYOTA SIENNA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V860000·2016-11-29

    StarTrans PS2 Transit Buses Recalled for Brake Indicator Malfunction

    Forest River is recalling 2016-2017 StarTrans PS2 buses because the instrument cluster may display 'PARK' instead of 'BRAKE' during a brake malfunction, increasing crash risk.

    Product
    STARTRANS — STARTRANS PS2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V851000·2016-11-25

    Gulf Stream Motorhomes Recalled for Improperly Wired In-Dash Radio Assembly

    Gulf Stream is recalling 2016-2017 Conquest and B Touring Cruiser motorhomes because the in-dash radio assembly was improperly wired, allowing the DVD to operate while the vehicle is in motion.

    Product
    GULF STREAM — GULF STREAM B TOURING CRUISER, CONQUEST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0508-2017·2016-11-23

    ICU Medical Recalls Pediatric CVL Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 40 Pediatric CVL Monitoring Kits containing Transpac IV transducers due to a potential for leak.

    Product
    PEDIATRIC CVL MONITORING KIT W/03ML FLUSH DEVICE FOR YALE NEW HAVEN HOSP., Item No. 46094-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0530-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir and Blood Sampling Kits

    ICU Medical is recalling specific SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    CATH LAB KIT w/3 PORT "OFF" MANIFOLD, WASTE BAG, GUIDE WIRE, SPLASH STOP, NEEDLE & TP-4, Item No. 46098The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0602-2017·2016-11-23

    Siemens Artis zee/zeego Angiographic X-ray Systems Recalled for Footswitch Defect

    Siemens is recalling Artis zee/zeego angiographic x-ray systems because the semi-automatic focus switch may fail when the footswitch is pressed multiple times.

    Product
    Artis zee/zeego, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures…
    Category
    Medical Device
    Distribution
    Distributed nationwide