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.

22501–22525 of 50430

  • HighNHTSA·20V446000·2020-07-30

    GM Recalls 2020 Vehicles Due to Roof-Rail Air Bag Defect

    General Motors is recalling 2020 Buick, Cadillac, Chevrolet, and GMC vehicles because the roof-rail air bag inflator may separate during deployment, increasing injury risk.

    Product
    GMC — GMC, CHEVROLET, CADILLAC SIERRA 1500, SILVERADO 3500, SILVERADO 1500, SILVERADO 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2676-2020·2020-07-29

    Boston Scientific Recalls IcePearl Cryoablation Needles Due to Surface Deterioration

    Boston Scientific is recalling 48 IcePearl 2.1 CX Cryoablation Needles because the needle surface deteriorated due to unexpected electrolysis during procedures.

    Product
    Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2670-2020·2020-07-29

    Becton Dickinson Recalls PowerLoc MAX Infusion Sets Due to Tubing Cracks

    Becton Dickinson is recalling PowerLoc MAX Power Injectable Infusion Sets because tubing may crack or break near the Luer or Y site, risking leakage of chemicals or blood.

    Product
    PowerLoc MAX Power Injectable Infusion Set; Catalog Numbers 0131910 (UDI 00801741047329), 0131915 (UDI 00801741047336), 0131975 (UDI 00801741047343), 0132010 (UDI 00801741047350), 0132015 (UDI 00801741047367), 0132075 (UDI 00801741047374), 0132210 (UDI 00801741047381), 0132215…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2643-2020·2020-07-29

    Wellspect Recalls LoFric Origo Urinary Catheters Due to Tip Defect

    Wellspect HealthCare is voluntarily recalling specific LoFric Origo urinary catheters because of a potential defect in the distal tip.

    Product
    LoFric Origo, Nelaton, 16in, FR10 urinary catheters
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-2674-2020·2020-07-29

    Boston Scientific Recalls IcePearl Cryoablation Needles Due to Surface Deterioration

    Boston Scientific is recalling IcePearl 2.0 CX 90 Cryoablation Needles because the needle surface deteriorated due to unexpected electrolysis during procedures.

    Product
    Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2673-2020·2020-07-29

    Medtronic Xomed IPC Software Upgrade Recalled for Speed Control Issue

    Medtronic Xomed is recalling IPC software upgrade v 2.7.3.0 because the M5 Microdebrider may rotate faster than the set value.

    Product
    Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing of soft and hard tissue and bone in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V442000·2020-07-29

    Fleetwood Pace Arrow Motorhomes Recalled for Battery Fire Risk

    REV Recreation Group is recalling 2019-2020 Fleetwood Pace Arrow motorhomes because loose battery brackets may cause a short circuit and fire.

    Product
    FLEETWOOD — FLEETWOOD PACE ARROW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2655-2020·2020-07-29

    Carefusion Safe-T Thora-Para Tray Recalled Due to Potential Air Leak

    Carefusion 2200 Inc is recalling Safe-T 8 Fr Thora-Para Trays because internal valve leaks may introduce up to 30cc of air into patients.

    Product
    Safe-T 8 Fr Thora-Para Tray With 8 Fr. Catheter and Sharps Injury Protection - Drug Free
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Food)·F-1029-2020·2020-07-29

    Chuckanut Bay Foods Recalls Red Velvet Cheesecake for Undeclared Walnut

    Chuckanut Bay Foods is recalling 60 Red Velvet Layered Cheesecakes distributed in California because the product contains undeclared walnuts.

    Product
    Red Velvet Layered Cheesecake is one whole cake (9" round cake) that has been pre-sliced into 14 slices and packaged in a white case box. Cheesecake is wrapped in a white band, ran through a shrink wrap machine and then put in a white case pack. Net weight: 82 oz. UPC…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2678-2020·2020-07-29

    Boston Scientific Recalls IceFORCE Prostate Kit Due to Needle Surface Deterioration

    Boston Scientific is recalling 79 IceFORCE 2.1 CX Prostate Kits because needle surfaces deteriorated due to unexpected electrolysis during procedures.

    Product
    Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2680-2020·2020-07-29

    Boston Scientific Recalls Prostate Cryoablation Kits Due to Needle Deterioration

    Boston Scientific is recalling 88 Prostate Cryoablation Kits because needle surfaces deteriorated during procedures due to unexpected electrolysis.

    Product
    Ablation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2658-2020·2020-07-29

    Carefusion Safe-T Thora-Para Tray Recalled for Internal Valve Leakage

    Carefusion 2200 Inc is recalling Safe-T 5 Fr Thora-Para Trays because internal valve leaks may introduce up to 30cc of air into patients.

    Product
    Safe-T 5 Fr Thora-Para Tray With 5 Fr. Catheter and Sharps Injury Protection - Drug Free
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2679-2020·2020-07-29

    Boston Scientific Recalls IcePearl 2.1 CX Prostate Kit Due to Needle Deterioration

    Boston Scientific is recalling 193 IcePearl 2.1 CX Prostate Kits because needle surfaces deteriorated due to unexpected electrolysis during procedures.

    Product
    Ablation Galil Technology, IcePearl¿2.1 CX Prostate¿Kit Visual Ice System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2682-2020·2020-07-29

    Boston Scientific Recalls IcePearl Cryoablation Needles Due to Surface Deterioration

    Boston Scientific is recalling 205 IcePearl 2.1 CX Cryoablation Needles because the needle surface deteriorated due to unexpected electrolysis during procedures.

    Product
    Ablation Galil Technology, IcePearl 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2689-2020·2020-07-29

    Philips IntelliVue G7m Anesthesia Gas Module Firmware Recall

    Philips is recalling 3,075 IntelliVue G7m Anesthesia Gas Modules due to a firmware issue that may interrupt gas measurement and display.

    Product
    IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2640-2020·2020-07-29

    EHOB Expansion Control Overlay Recalled for Potential Blood Contamination

    EHOB, Inc. is recalling 173 Expansion Control Overlays (Item No. 1004EC) because a portion of the lot may have been contaminated with blood.

    Product
    Expansion Control Overlay, Item No. 1004EC - Product Usage: The EHOB WAFFLE Overlay is more than a support surface, assisting in lateral transfers, boosts and turns to protect patients throughout the hospital journey. Through immersion and envelopment, the WAFFLE Overlay is…
    Category
    Medical Device
    Distribution
    Distributed nationwide