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.

23326–23350 of 50435

  • HighFDA (Devices)·Z-1785-2020·2020-04-29

    Degania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures

    Degania Medical Devices is recalling specific lots of temperature sensing Foley catheters because inadequate inspection practices were used on the thermistor sensors during production.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101663DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1774-2020·2020-04-29

    Medivators Recalls Endo Smartcap Endoscope Tubing Due to Manufacturing Anomaly

    Medivators is recalling Endo Smartcap Endoscope Tubing due to a manufacturing anomaly that may cause inadequate insufflation, air bubbles, or water leaks during procedures.

    Product
    Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXTU, packaged as Contents 1, 10, 50. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes With Extended CO2 Input. Sterile EO - Product Usage: is intended to be used with an air or CO2 source and/or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1779-2020·2020-04-29

    Degania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures

    Degania Medical Devices is recalling specific lots of temperature sensing Foley catheters because inadequate incoming inspection practices were used on the thermistor sensors.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1755-2020·2020-04-29

    Radiometer TCM4 Base Unit Recalled for Display Flickering and Unresponsiveness

    Radiometer Medical ApS is recalling 84 TCM4 Base units due to reports of display flickering and unresponsiveness, which may delay patient monitoring.

    Product
    TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-946 or 902-862), TCM400 (902-564), TOSCA (903-044) and CombiM (903-111) - Product Usage: It is indicated for use on pediatrics and adults.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1780-2020·2020-04-29

    Degania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures

    Degania Medical Devices is recalling 1,929 temperature sensing Foley catheters because inadequate inspection practices were used on the thermistor sensors during production.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101063MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1776-2020·2020-04-29

    Medivators Recalls Endo SmartCap Tubing Due to Manufacturing Anomaly

    Medivators is recalling Endo SmartCap Tubing kits due to a manufacturing anomaly that may cause inadequate insufflation or water leaks during endoscopic procedures.

    Product
    Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes forCO2 Connection with Olympus OFP or Boston Scientific Endostat II Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Olympus 140/240…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1781-2020·2020-04-29

    Degania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures

    Degania Medical Devices is recalling 700 temperature sensing Foley catheters because inadequate inspection practices were used on the thermistor sensors.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1754-2020·2020-04-29

    KT Health Recalls Ice/Heat Massage Balls Due to Leak Risk

    KT Health, LLC is recalling 94,554 KT RECOVERY+ Ice/Heat Massage Balls because overheating may cause leaks, potentially exposing users to hot fluid.

    Product
    KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be interchanged depending on the therapy type desired
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V242000·2020-04-29

    MCI Buses Recalled for Seat Belts That May Not Extend

    Motor Coach Industries is recalling certain 2015-2020 buses because seat belts may not extend from the retracted position, rendering them unusable.

    Product
    MCI — MCI D4505, D4000, D4500, J4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V237000·2020-04-28

    Forest River Recalls 2020 StarTrans PS2 Buses for Seat Belt Defect

    Forest River is recalling 2020 StarTrans PS2 transit buses because seat belt retractors may not secure occupants properly, increasing injury risk in crashes.

    Product
    STARTRANS — STARTRANS PS2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E026000·2020-04-24

    Denso Fuel Pump Recall for Potential Engine Stall Risk

    Denso is recalling certain fuel pumps where an impeller may crack and deform. This defect can cause the engine to stall while driving, increasing the risk of a crash.

    Product
    FUEL SYSTEM, GASOLINE:DELIVERY:FUEL PUMP recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E025000·2020-04-24

    Ford Recalls Replacement Headlamps for 2013-2016 Lincoln MKZ Vehicles

    Ford is recalling specific replacement headlamps for 2013-2016 Lincoln MKZ vehicles because they may have improper beam patterns and missing markings, potentially reducing visibility.

    Product
    LINCOLN — LINCOLN MKZ
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20738·2020-04-23

    LUS Recalls Hair Dryers Due to Electrocution or Shock Hazard

    LUS Distribution Inc. is recalling approximately 2,700 hair dryers and diffusers sold in the U.S. because they lack immersion protection, posing an electrocution or shock hazard if they fall into water.

    Product
    LUS Hair Dryers & Diffusers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1703-2020·2020-04-22

    Sysmex CF-70 Blood Smear Transporter Recalled for Software Mismatch Hazard

    Sysmex America is recalling 93 CF-70 instruments because a software mismatch may prevent the device from halting when the cover door is opened.

    Product
    The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, selects only smears that require analysis, and transports them to the DI-60 for further analysis. After completing the analysis on DI-60 the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1693-2020·2020-04-22

    Medtronic NavLock Tracker Recalled Due to Incorrect Assembly

    Medtronic Navigation is recalling one unit of the NavLock Tracker because incorrect assembly could affect navigation accuracy.

    Product
    NavLock Tracker *** Rx Only
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1699-2020·2020-04-22

    Stago STA-Deficient VIII Plasma Recalled for Cross-Contamination Risk

    Diagnostica Stago is recalling STA-Deficient VIII plasma due to a risk of sample-to-sample cross-contamination that may cause falsely increased factor VIII levels.

    Product
    STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended for use in tests for the determination of factor VIII activity in plasma on STA-R and STA Compact analyzer platforms as follows: (A) STA-R Max, Product Codes: 58989…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0909-2020·2020-04-22

    DSD Merchandisers Recalls Deluxe Mixed Nuts Due to Undeclared Peanuts

    DSD Merchandisers is recalling Roasted/Salted Deluxe Mixed Nuts because peanuts were included in the mix but not declared on the label.

    Product
    Roasted/Salted Deluxe Mixed Nuts; Net Wt. 10 oz./284 g, Clear plastic container UPC 65143370994 Cashews, Almonds, Brazil Nuts, Hazelnuts, Pecan Halves, Macadamia Nuts, Canola Oil, salt. Contains Tree nuts (Cashews, Almonds, Brazil Nuts, Hazelnuts, Macadamia Nuts…
    Category
    Food
    Distribution
    5 states
  • HighNHTSA·20V226000·2020-04-22

    Mercedes-Benz Recalls 2020 GLE Models Due to Air Bag Wiring Defect

    Mercedes-Benz is recalling 2020 GLE 350 and GLE 450 vehicles because a pinched wiring harness may prevent rear side air bags from deploying correctly.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLE 350, GLE 450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1715-2020·2020-04-22

    Smiths Medical Recalls Portex Arterial Blood Sampling Syringes with Broken Luer

    Smiths Medical ASD, Inc. is recalling Portex LineDraw Arterial Blood Sampling Syringes because the luer connectors may be broken.

    Product
    Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-1716-2020·2020-04-22

    Smiths Medical Recalls Arterial Blood Sampling Kits with Broken Luer Defect

    Smiths Medical is recalling Portex Pro-Vent Arterial Blood Sampling Kits because some lots may have broken luer connectors.

    Product
    Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-1692-2020·2020-04-22

    Encore Medical Recalls djosurgical Linear Neck Trials Due to Retaining Ring Failure

    Encore Medical is recalling 28 djosurgical Linear Neck Trials because the retaining ring has a potential to fail inter-operatively.

    Product
    djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral, nonsterile, REF S-200636. The firm name on the label is djosurgical, Austin, TX.
    Category
    Medical Device
    Distribution
    7 states