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.

20126–20150 of 50413

  • HighNHTSA·21V459000·2021-06-17

    Spartan Fire Recalls 2019-2021 S-180 Pumper Emergency Vehicles

    Spartan Fire is recalling 2019-2021 S-180 Pumper emergency vehicles because a pump shift harness defect may prevent the vehicle from shifting into pump mode.

    Product
    SPARTAN FIRE — SPARTAN FIRE S-180 PUMPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V453000·2021-06-17

    2021 Heartland Mallard trailers recalled for potentially leaky LP gas cooktop lines

    Heartland Recreational Vehicles is recalling certain 2021 Mallard and other trailers because LP gas lines on outside cooktops may not have been tightened properly, creating a risk of gas leaks and fire.

    Product
    HEARTLAND — HEARTLAND WILDERNESS, TRAIL RUNNER, NORTH TRAIL, MALLARD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V456000·2021-06-17

    Terex Advance Recalls 2021 Front Discharge Mixers Due to Chute Defect

    Terex Advance is recalling 188 units of 2021 Front Discharge Mixers because a shaft key was not installed properly, which could cause unintentional chute movement and increase the risk of injury.

    Product
    TEREX ADVANCE — TEREX ADVANCE FRONT DISCHARGE MIXER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1805-2021·2021-06-16

    Alphatec Insignia Anterior Cervical Plate Screw Mechanism Failure Recall

    Alphatec Spine is recalling the Insignia Anterior Cervical Plate System because the screw blocking mechanism may disassociate during surgery or unlock afterward. Eight units were distributed across 15 states.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-Level, 22 mm, Rx Only, Non-Sterile, UDI: (01)00190376268484
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1831-2021·2021-06-16

    Laboratory Software Device May Produce Erroneous Results from Inadequate Instructions

    Normand Remisol Advance Data Manager versions 1.5–1.9 have insufficient instructions for proper rule programming and testing. User-written rules may not be properly validated, potentially leading to erroneous laboratory results.

    Product
    Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1802-2021·2021-06-16

    Alphatec Insignia Anterior Cervical Plate Screw Blocking Mechanism Disassociation Recall

    Alphatec Spine is recalling the Insignia Anterior Cervical Plate System due to a potential failure in the screw blocking mechanism that may disassociate or unlock during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0119, Insignia, ACP, 1-Level, 19 mm, Rx Only, Non-Sterile, UDI: (01)00190376268453
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1847-2021·2021-06-16

    CooperSurgical Wallach Loop Electrode recalled for incorrect packaging

    CooperSurgical has recalled its Wallach Loop Electrodes (Lot 274420) due to incorrect packaging. Packages labeled as Square Electrodes contained Round Electrodes instead, creating a risk of improper device use in surgical procedures.

    Product
    CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP electrodes, used for electro-excisional procedures, and for electro-fulguration procedures of the lower genital tract
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1812-2021·2021-06-16

    Anterior Cervical Plate System Screw Mechanism May Fail Intraoperatively

    Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism that could disassociate or unlock during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-Level, 42 mm, Rx Only, Non-Sterile, UDI: (01)00190376268415
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1844-2021·2021-06-16

    Quanta System Sterile Optical Laser Fiber Recall for Potential Sterility Compromise

    Quanta System is recalling 307 reusable sterile optical laser fibers nationwide due to potential sterility compromise. The affected devices were distributed through six U.S. distributors.

    Product
    Quanta System Sterile Optical Laser Fiber, reusable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21151·2021-06-16

    Cove Appliance 24-inch Built-in Dishwashers Recalled for Fire Hazard

    Cove Appliance is recalling about 42,000 built-in dishwashers because the heating element can fail to shut off and overheat, creating a fire hazard. The company has received five reports of burning smells, flames, and smoking inside the dishwashers, though no injuries have been reported.

    Product
    Cove Appliance 24-inch built-in dishwashers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1796-2021·2021-06-16

    Diagnostic MR imaging system hoisting blocks mechanical defect

    Philips is recalling 156 Ingenia Ambition S diagnostic MR systems due to a mechanical issue detected in the lifting blocks on the magnet used during equipment movement and decommissioning.

    Product
    Ingenia Ambition S - Model Number: 781359 Diagnostic MR system.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1804-2021·2021-06-16

    Atec Insignia Anterior Cervical Plate System Recall: Potential Screw Mechanism Failure

    Alphatec Spine is recalling 7 units of the Atec Insignia Anterior Cervical Plate System because the screw blocking mechanism could disassociate or unlock during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21 mm, Rx Only, Non-Sterile, UDI: (01)00190376268477
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1813-2021·2021-06-16

    Atec Insignia Anterior Cervical Plate System recall due to potential screw mechanism failure

    Alphatec Spine is recalling Atec Insignia Anterior Cervical Plate System units due to a potential defect where the screw blocking mechanism may disassociate or unlock during or after surgery. No adverse events have been reported.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-Level, 44 mm, Rx Only, Non-Sterile, UDI: (01)00190376268507
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1795-2021·2021-06-16

    Ingenia Ambition X MRI Systems: Mechanical Defect in Hoisting Blocks

    Philips has recalled 156 Ingenia Ambition X MRI systems due to a mechanical defect in the hoisting blocks used to move the magnet during decommissioning or relocation. The defect poses a risk that the magnet could fall.

    Product
    Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1838-2021·2021-06-16

    Medical Device Software Defects in RayStation Treatment Planning System

    RayStation radiation therapy treatment planning software versions 6 through 10A contain defects that may cause misleading dose evaluations and contouring errors. Healthcare facilities should verify treatment plans and contact the manufacturer for guidance.

    Product
    RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.6 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 , 10.0.0.1154 , 10.0.1.52 or 10.1.0.613 .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1836-2021·2021-06-16

    ViewRay MRIdian Linac System software anomalies in non-English versions

    Viewray, Inc. is recalling MRIdian Linac System treatment delivery software in French, German, and Italian versions due to software anomalies affecting radiation therapy systems.

    Product
    ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1820-2021·2021-06-16

    Atec Insignia Anterior Cervical Plate System Screw Mechanism Recall

    Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System due to potential disassociation or postoperative unlock of the screw blocking mechanism during or after cervical spine surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0358 Insignia, ACP, 3-Level, 58 mm, Rx Only, Non-Sterile, UDI: (01)00190376268606
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1801-2021·2021-06-16

    Anterior cervical plate system screw mechanism may disassociate during or after surgery

    Alphatec Spine's Atec Insignia Anterior Cervical Plate System has a potential defect where the screw blocking mechanism may disassociate during or after surgery, which could compromise spinal stabilization.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0118, Insignia, ACP, 1-Level, 18 mm, Rx Only, Non-Sterile, UDI: (01)00190376268446
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1797-2021·2021-06-16

    Medtronic Braive Growth Modulation System Break-Off Set Screws Recalled for Thread Defect

    Medtronic is recalling Braive Growth Modulation System Break-Off Set Screws due to a thread profile defect caused by a manufacturing issue. The defect may affect proper device function.

    Product
    Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spinal curvature and provide correction of the thoracic curve while allowing continued skeletal growth by compression of the convex side of the scoliotic curve.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0663-2021·2021-06-16

    Adobo para Chorizo Seasoning Recalled for Undeclared Soy Lecithin

    Jesmar Spices, LLC is recalling Adobo para Chorizo Seasoning for Sausage because it contains undeclared soy lecithin from chocolate used in the product. The allergen is not listed on the product label.

    Product
    Adobo para Chorizo - Chorizo Marinade - Seasoning for Sausage. Product is packaged in a plastic bucket seal with lid, 5 gallons. No UPC. The label is read in parts: "*** Adobo para Chorizo *** Seasoning for Sausage *** Ingredients: Dried Chilies, vinegar, almonds, salt…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1803-2021·2021-06-16

    Cervical Spine Plate System Screw Mechanism May Disassociate or Unlock

    Alphatec Spine recalls its Atec Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism, which may disassociate or unlock during or after spinal surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20 mm, Rx Only, Non-Sterile, UDI: (01)00190376268460
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1824-2021·2021-06-16

    Alphatec Insignia Cervical Plate System: Screw Mechanism Disassociation Risk

    Alphatec recalls the Insignia Anterior Cervical Plate System due to risk that the screw blocking mechanism may disassociate during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-Level, 68 mm, Rx Only, Non-Sterile, UDI: (01)00190376268675
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1822-2021·2021-06-16

    Anterior Cervical Plate System Screw Mechanism Recall

    Alphatec Spine recalls Atec Insignia Anterior Cervical Plate Systems because the screw blocking mechanism may fail during or after surgery. The mechanism may disassociate or unlock, potentially compromising implant stability.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-Level, 62 mm, Rx Only, Non-Sterile, UDI: (01)00190376268620
    Category
    Medical Device
    Distribution
    Distributed nationwide