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.

15151–15175 of 53092

  • HighFDA (Devices)·Z-0363-2023·2022-12-14

    IgM and IgA Assay Kits Recalled for Test Carryover Risk

    Randox Laboratories recalls IgM and IgA immunoturbidimetric assay kits due to carryover contamination that can cause elevated test results when run immediately after Fructosamine tests on RX instruments.

    Product
    IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0355-2023·2022-12-14

    Siemens IMMULITE Testosterone Assay Recalled for Measurement Bias

    Siemens is recalling two lots of its IMMULITE Total Testosterone Assay due to a confirmed 40% positive measurement bias at higher testosterone levels, which may delay diagnosis and require repeat testing.

    Product
    IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers for the quantitative measurement of total testosterone in serum and heparinized plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0364-2023·2022-12-14

    Treadmill Magnetic Safety Tether May Fail to Stop During Fall

    Full Vision Inc. TrackMaster treadmills with specific serial numbers have a circuit defect that may prevent the magnetic safety tether from stopping the treadmill during a fall.

    Product
    FULL VISION INC. TRACKMASTER, TREADMILL TMX428 110V, Model #317-07926
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0366-2023·2022-12-14

    Full Vision TrackMaster Treadmill Safety Tether May Fail During Fall

    Full Vision Inc. is recalling TrackMaster treadmills due to a circuit defect in the safety tether. If the magnet detaches during a fall, the treadmill may fail to stop.

    Product
    FULL VISION INC. TRACKMASTER, TREADMILL TMX428CP 110V, Model #317-07928
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0409-2023·2022-12-14

    Bipolar Forceps Recall Due to Incomplete Instructions for Use

    BD is recalling CareFusion bipolar forceps due to incomplete Instructions for Use. The IFU is missing critical information about power supply interface and cleaning/maintenance procedures.

    Product
    CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, STRAIGHT, FINE 0.5MM TIP OVERALL LENGTH 8-3/4" (225MM), REF F-5125
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0194-2023·2022-12-14

    Big Sky Granola Recalled for Undeclared Milk Allergen in Labeling

    Big Sky Chocolate Chunk Peanut Butter Chip Granola (14oz) is being recalled because the product labeling fails to disclose milk allergen in its sub-ingredients. Consumers with milk allergies should not consume this product.

    Product
    Big Sky Chocolate Chunk Peanut Butter Chip Granola, Net Wt 14oz; UPC 602503 004808
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0382-2023·2022-12-14

    Surgical Bipolar Forceps Recalled for Missing Instructions

    Carefusion is recalling the V. Mueller Bipolar Forceps Insulated due to missing instructions for power supply interface and cleaning/maintenance procedures.

    Product
    Carefusion V. Mueller"GERALD BIPOLAR FORCEPS INSULATED, 1.0MM TIP OVERALL LENGTH 7" (180MM), REF F-1112
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0369-2023·2022-12-14

    Treadmill Magnetic Safety Tether Circuit May Fail During Falls

    Full Vision Inc. is recalling 165 TrackMaster treadmills due to a circuit defect in the magnetic safety tether that may prevent the equipment from stopping when a user falls.

    Product
    FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST2 220V, Model #317-07927GE
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0357-2023·2022-12-14

    Dover Urethral Catheter Drainage System Recall for Potential Port Blockage

    Cardinal Health is recalling Dover closed urethral catheter trays because the drainage bag port may become occluded, preventing urine from draining properly and increasing the risk of urinary retention.

    Product
    Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Product Code: 3408 Intended for urinary drainage from the bladder of a patient
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0416-2023·2022-12-14

    Bipolar Surgical Forceps Recalled Due to Missing Instructions for Use

    CareFusion 2200 Inc is recalling V. Mueller bipolar forceps (model F-5304) due to missing Instructions for Use content related to power supply interface and cleaning/maintenance procedures.

    Product
    CareFusion V. Mueller Neuro/Spine TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 0.5MM TIP, ANGLED-UP, FINE OVERALL LENGTH 8-3/4" (225MM), REF F-5304
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0395-2023·2022-12-14

    CareFusion Bipolar Forceps Recalled for Incomplete Instructions for Use

    CareFusion 2200 Inc is recalling 4,557 units of V. Mueller ADSON Bipolar Forceps due to incomplete Instructions for Use. The IFU is missing content about power supply interface and cleaning and maintenance instructions.

    Product
    CareFusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP, INSULATED OVERALL LENGTH 4-3/4" (120MM), REF F-3015
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0458-2023·2022-12-14

    Propel Mini Sinus Implant Recalled for Incorrect Product Label Information

    Intersect ENT is recalling 611 units of Propel Mini Mometasone Furoate Sinus Implant due to incorrect product identification information on the label. The label displays wrong reference numbers and UDI-DI codes.

    Product
    Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0463-2023·2022-12-14

    Philips MR 7700 System Upgrade Recalled Due to Gradient Coil Fire Risk

    Philips is recalling the Upgrade to MR 7700 System (Model 782130) because the gradient coil may act as a heat source and produce smoke or fire. Affected units should not be operated until Philips provides further guidance.

    Product
    Philips Upgrade to MR 7700 System, Model Number 782130
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0460-2023·2022-12-14

    Philips Ingenia Elition X MR System Gradient Coil Fire and Smoke Hazard

    Philips is recalling 566 Ingenia Elition X MRI systems nationwide. The gradient coil may act as a heat source with the potential to produce smoke and/or fire.

    Product
    Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0375-2023·2022-12-14

    Carefusion Bipolar Forceps Recalled Due to Missing Instructions for Use

    Carefusion is recalling 347 units of SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS due to incomplete Instructions for Use. The missing content covers power supply interface and maintenance procedures.

    Product
    Carefusion V. Mueller" SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIP INSULATED, OVERALL LENGTH 7-3/4" (195MM), REF F-1003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0385-2023·2022-12-14

    Surgical Bipolar Forceps Recalled Due to Incomplete Instructions for Use

    Carefusion recalls V. Mueller bipolar forceps with incomplete instructions. The device lacks critical information on power supply interface and cleaning procedures.

    Product
    Carefusion V. Mueller GERALD BAYONET IRRIGATING BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 7-1/2" (190MM), REF F-1301
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0184-2023·2022-12-14

    Nestle Toll House Cookie Dough recalled for potential foreign material

    Nestle recalls Toll House Edible Chocolate Chip Cookie Dough (15oz tubs) for potential foreign material contamination. Approximately 18,671 cases affected across multiple US states.

    Product
    Nestle Toll House Edible Chocolate Chip Cookie Dough packaged in 15oz tubs - 4 tubs per case
    Category
    Food
    Distribution
    35 states
  • HighFDA (Devices)·Z-0459-2023·2022-12-14

    Philips MRI System Gradient Coil May Produce Smoke or Fire

    Philips is recalling certain Ingenia Elition S MR Systems due to a potential fire or smoke hazard from the gradient coil. The affected units are distributed nationwide in the United States.

    Product
    Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0420-2023·2022-12-14

    Spinal implant screws recalled for potential weld separation

    Integrity Implants recalls 1,369 spinal implant screws due to potential weld separation between components. No injuries have been reported.

    Product
    LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0367-2023·2022-12-14

    Treadmill Safety Tether Circuit Defect May Prevent Emergency Stop

    Full Vision Inc. Trackmaster treadmills have a rare circuit defect that may prevent the safety tether from stopping the machine during a fall.

    Product
    FULL VISION INC. TRACKMASTER, TREADMILL TMX428CP 220V, Model #317-07929
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0387-2023·2022-12-14

    Bipolar Forceps Recall Due to Incomplete Instructions for Use

    BD recalled Carefusion bipolar forceps due to missing Instructions for Use content regarding power supply interface and cleaning/maintenance. Affected units distributed nationwide and internationally.

    Product
    Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIPS, IRRIGATING OVERALL LENGTH 7-3/4" (19.7CM), REF F-1304
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0371-2023·2022-12-14

    2.5 mm LifePort Endotracheal Tube Adapters Deformation Risk

    Bunnell's 2.5 mm LifePort Endotracheal Tube Adapters may deform due to improper packaging, potentially affecting ventilator performance. The defect may lead to hypercarbia, hypoxia, and gas trapping.

    Product
    2.5 mm LifePort Endotracheal Tube Adapters 10-pack, Catalog: 9025; and 2.5 mm LifePort Endotracheal Tube Adaptors inside Patient Circuit Kits, Catalog: 938
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0422-2023·2022-12-14

    Getinge Flow-c and Flow-e Anesthesia Systems: Backup Battery Failure Risk

    Getinge Flow-c and Flow-e anesthesia systems are recalled due to backup battery defects that may fail during power outages, potentially requiring manual emergency ventilation. 65 units affected in six US states.

    Product
    Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0421-2023·2022-12-14

    Spinal pedicle screws recalled for potential intraoperative screw head separation

    Integrity Implants Inc. is recalling LineSider Spinal System pedicle screws (Model LS-N6SG6545) due to potential screw head separation at the weld location during surgery. This Class II recall affects units distributed to California, Indiana, New York, Oklahoma, and Washington DC.

    Product
    LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N6SG6545. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective…
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Food)·F-0192-2023·2022-12-14

    ARASHAN Mixed Dried Fruit Recalled for Undeclared Sulfites

    ARASHAN brand mixed dried fruit (1 lb bags) is being recalled due to undeclared sulfites. The product was distributed in Illinois, New York, New Jersey, and Pennsylvania.

    Product
    ARASHAN brand mixed dried fruit packaged in 1lb clear plastic bags with a sticker label. UPC: 850008491368
    Category
    Food
    Distribution
    4 states