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.

30151–30175 of 50499

  • HighFDA (Devices)·Z-0259-2018·2018-01-17

    Orthoscan Mobile Mini C-arm System Recalled for Software Defect

    Orthoscan is recalling 2,012 Mobile Mini C-arm systems because a software defect allows users to activate Digital Zoom during live imaging, exposing a larger x-ray field than is visible to the user.

    Product
    Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0560-2018·2018-01-17

    Ingles Markets Recalls Frozen Biscuits for Listeria Contamination

    Ingles Markets is recalling frozen Southern Style Biscuits after testing revealed Listeria monocytogenes contamination. The product was distributed in Georgia, North Carolina, South Carolina, and Tennessee.

    Product
    Frozen Southern Style Biscuits; 25 oz. bags (12 count)
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0561-2018·2018-01-17

    Ingles Markets Recalls Frozen Buttermilk Biscuits Due to Listeria

    Ingles Markets is recalling specific bags of frozen buttermilk biscuits because testing found Listeria monocytogenes. Consumers in Georgia, North Carolina, South Carolina, and Tennessee should not eat the product.

    Product
    Frozen Buttermilk Biscuits 25 oz. bag (12 count) and 44 oz. bag (20 count)
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0321-2018·2018-01-17

    Ambu Universal Flex2 Breathing Circuits Recalled for Leak Test Failures

    King Systems Corp. dba Ambu, Inc. is recalling 871,116 Universal Flex2 Breathing Circuits due to potential leak test failures.

    Product
    UNIVERSAL FLEX2 BREATHING CIRCUIT, Item Numbers: D460-6133Z, D390-6121Z, D390-6121Z, D495-61Z, DF4116-6121Z, D466-61Z, DFP170-6121, DF3115-6121Z, DF375-6121Z, DF3115-6121Z, DF3115-6121Z, D360-8031Z, D465-61Z, JD365-6033Z, DF370-6121Z, DF3110-61Z, DF375-17621Z, DF375-6121Z…
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-0326-2018·2018-01-17

    Encore Medical Recalls DJO EMPOWR Knee Locking Tibial Punch Guide

    Encore Medical is recalling 2 units of the DJO EMPOWR Knee Locking Tibial Punch Guide because the device did not sufficiently guide the punch, causing implants to be placed 2-3mm more posterior than intended.

    Product
    DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty 1 For use in orthopedic surgery.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0261-2018·2018-01-17

    OrthoScan Recalls Mobile Mini C-arm Systems Due to Software Defect

    OrthoScan is recalling 2,012 Mobile Mini C-arm systems because a software defect allows users to activate Digital Zoom during live imaging, exposing a larger x-ray field than visible.

    Product
    Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0331-2018·2018-01-17

    Philips Brilliance iCT CT Scanner Recall Due to Potential Gantry Screw Failure

    Philips is recalling 702 Brilliance iCT computed tomography systems because screws holding an internal gantry component may come loose, potentially causing noise.

    Product
    Philips Healthcare Brilliance iCT computed tomography x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0318-2018·2018-01-17

    Repro-Med HIgH-Flo Subcutaneous Safety Needle Sets Recalled for Packaging Defects

    Repro-Med Systems is recalling HIgH-Flo Subcutaneous Safety Needle Sets because gaps were found in the sterile barrier packaging during post-sterilization inspection.

    Product
    HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Numbers RMS22606, RMS22609, RMS22612, RMS12606, RMS22409, RMS32609, RMS32609, RMS12409, RMS12609, RMS62612, RMS62606, RMS12406, RMS22412, RMS12412, RMS42606, RMS62609, RMS52612, RMS42612…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0327-2018·2018-01-17

    Encore Medical Recalls EMPOWR Porous Knee System Tibial Punch

    Encore Medical is recalling two units of the EMPOWR Tibial Punch because the locking guide failed to properly position the implant.

    Product
    EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Qty 1 For use in orthopedic surgery.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0323-2018·2018-01-17

    CareFusion Alaris PCA Pump Recall Due to Syringe Plunger Gripper Failure

    CareFusion is recalling Alaris PCA Pumps because the syringe plunger grippers may fail to close automatically, potentially affecting medication delivery.

    Product
    Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PCA pump delivers medication or fluids in a manner similar to current syringe…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0317-2018·2018-01-17

    Repro-Med Systems Recalls Freedom60 Precision Flow Rate Tubing Sets

    Repro-Med Systems is recalling Freedom60 Precision Flow Rate Tubing Sets and related needle sets because gaps were found in the sterile barrier packaging during inspection.

    Product
    Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200 F180.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0333-2018·2018-01-17

    Philips IQon Spectral CT Scanner Recall Due to Potential Gantry Screw Failure

    Philips is recalling IQon Spectral CT systems because screws holding the internal gantry to the main bearing may come loose, potentially causing noise.

    Product
    Philips Healthcare IQon Spectral CT computed tomography x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0654-2018·2018-01-17

    Lovebiotics Coconut Yogurt Recalled for Undeclared Milk Allergen

    Lovebiotics, LLC is recalling The Coconut Cult Coconut Cream Probiotic Coconut Yogurt because the label lists sodium caseinate but fails to explicitly identify milk as an allergen.

    Product
    The Coconut Cult Coconut Cream Probiotic Coconut Yogurt NET WT. 8 OZ, 16 OZ, 32 OZ UPC 611138765282, 611138765275, 611138765268
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-0260-2018·2018-01-17

    OrthoScan Recalls Mobile Mini C-arm Systems Due to Software Defect

    OrthoScan is recalling 2,012 Mobile Mini C-arm systems because a software defect allows users to activate Digital Zoom during live imaging, exposing a larger x-ray field than visible.

    Product
    Mobile Mini C-arm system Part # 1000-0005. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V059000·2018-01-16

    Liberty Recalls 2018 Little Guy Max Trailers Due to Jack Defect

    Liberty is recalling 2018 Little Guy Max trailers because a cracked touch pad on the power tongue jack may allow water entry, causing the jack to operate unintentionally.

    Product
    LIBERTY — LIBERTY LITTLE GUY MAX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18079·2018-01-16

    Fujifilm Recalls Power Adapter Wall Plugs Due to Shock Hazard

    Fujifilm is recalling power adapter wall plugs sold with certain digital cameras because they can crack or break, exposing live electrical contacts and posing a shock hazard.

    Product
    Power adapter wall plugs sold with Fujifilm digital cameras
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V055000·2018-01-16

    Indian Recalls 2015-2017 Roadmaster Motorcycles Due to Wiring Defect

    Indian Motorcycle is recalling 2015-2017 Roadmaster models because water in the trunk wiring harness may cause the brake light to stay on, increasing crash risk.

    Product
    INDIAN — INDIAN ROADMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V058000·2018-01-16

    Ford Recalls 2018 Expedition and Navigator for Window Control Defect

    Ford is recalling 2018 Expedition and Lincoln Navigator vehicles because second-row power window modules may fail to reverse if an object is pinched, increasing injury risk.

    Product
    LINCOLN — LINCOLN, FORD NAVIGATOR, EXPEDITION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V053000·2018-01-15

    Foretravel Recalls Motorhomes Due to Defective Fire Extinguishers

    Foretravel is recalling 2004-2019 motorhomes because the installed fire extinguishers may clog or detach, potentially failing to work during a fire.

    Product
    FORETRAVEL — FORETRAVEL NIMBUS, U320, REALM, PHENIX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V051000·2018-01-12

    Forest River Recalls 2017-2018 Recreational Trailers Due to Power Tongue Jack Defect

    Forest River is recalling specific 2017-2018 recreational trailers because a cracked touch pad on the power tongue jack may allow water entry, causing the jack to operate unintentionally.

    Product
    FOREST RIVER — FOREST RIVER, COACHMEN XLR, FREEDOM EXPRESS, VIKING, ROCKWOOD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V047000·2018-01-11

    Mitsubishi Fuso Trucks Recalled for Defective Kidde Fire Extinguishers

    Mitsubishi Fuso is recalling 2004-2017 trucks because the installed Kidde fire extinguishers may clog or detach, potentially failing to suppress fires or causing injury.

    Product
    MITSUBISHI FUSO — MITSUBISHI FUSO FEC52, FGB72, FEC92, FEC72
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V050000·2018-01-11

    Pierce Emergency Vehicles Recalled for Water Pump Valve Defect

    Pierce is recalling 2015-2016 emergency vehicles because corroded rings may cause pressure relief valves to open, reducing water pressure for firefighting.

    Product
    PIERCE — PIERCE ENFORCER, QUANTUM, ARROW XT, SABER
    Category
    Vehicle
    Distribution
    Distributed nationwide