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.

23276–23300 of 50435

  • HighFDA (Devices)·Z-1827-2020·2020-05-06

    Capso Vision Recalls CapsoCAM Plus Capsule Endoscopy Systems

    Capso Vision is recalling 1,882 CapsoCAM Plus capsule endoscopy systems because a defect in the capsule window may cause the housing to crack and leak during use.

    Product
    CapsoCAM Plus, UDI: 00867770000209
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1818-2020·2020-05-06

    Welch Allyn Q-Tel RMS System Recalled for Defibrillation Safety Non-Compliance

    Welch Allyn is recalling 78,521 Q-Tel RMS systems because they may not meet defibrillation withstand safety requirements.

    Product
    Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation data acquisition and editing system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1709-2020·2020-05-06

    GE Healthcare Recalls Lunar iDXA Bone Densitometers Due to Radiation Risk

    GE Healthcare is recalling 123 Lunar iDXA bone densitometers because a control panel defect may cause the start button to stick, potentially leading to accidental radiation exposure.

    Product
    Lunar iDXA bone densitometer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1819-2020·2020-05-06

    Welch Allyn ECG Lead Sets Recalled for Defibrillation Safety Non-Compliance

    Welch Allyn is recalling 78,521 ECG lead sets because they may not meet defibrillation withstand safety requirements.

    Product
    Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG front-end for various Electrocardiographs. Sold under the following device names: LEAD SET WAM 10 WIRE BANANA AHA GRAY, LEAD SET WAM 10 WIRE BANANA IEC GRAY, RPLCE LD SET WAM/AM12 LIMBS BANA AHA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1813-2020·2020-05-06

    Welch Allyn T12 Wireless ECG Devices Recalled for Defibrillation Safety

    Welch Allyn is recalling T12 wireless ECG devices because they may not meet defibrillation withstand safety requirements.

    Product
    T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of simultaneous 12-lead ECG data with diagnostic quality while allowing the patient to be ambulatory.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1826-2020·2020-05-06

    Elekta Recalls Leksell Vantage Stereotactic System Instrument Carriers

    Elekta Inc is recalling 25 Leksell Vantage Stereotactic System Instrument Carriers because a faulty locking piece may not meet required locking force standards.

    Product
    Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1815-2020·2020-05-06

    Welch Allyn S4 Wireless Telemeter Recall for Defibrillation Safety

    Welch Allyn is recalling S4 Wireless Telemeters and patient cables because they may not meet defibrillation withstand safety standards.

    Product
    S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 10 WIRE LF ECG SNAP ENDS AHA GRAY, CABLE 10 WIRE LF ECG SNAP ENDS IEC GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS AHA GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS IEC GRAY. The S4 mobile monitor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1817-2020·2020-05-06

    Welch Allyn Q-Stress and XScribe Diagnostic Devices Recalled for Safety Standard Deficiency

    Welch Allyn is recalling Q-Stress and XScribe diagnostic devices because they may not meet specific defibrillation withstand safety requirements.

    Product
    Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real time ECG display, heart rate measurement, ST analysis and ventricular ectopic beat detection using wired or wireless acquisition modules.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1823-2020·2020-05-06

    U&I Corp. Recalls Velofix SA Cervical Cages Due to Dimensional Defects

    U&I Corp. is recalling 42 Velofix SA cervical cages because screw-hole dimensions may be out of range, posing a risk of screw pullout or instability.

    Product
    Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disk disease at one level…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1822-2020·2020-05-06

    Avanos Medical Recalls CORFLO PEG Kits Due to Potential Adapter Occlusion

    Avanos Medical is recalling CORFLO Percutaneous Endoscopic Gastrostomy (PEG) Kits because the tube may become blocked at the adapter, potentially delaying or aborting procedures.

    Product
    CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1711-2020·2020-05-06

    GE Healthcare Recalls Lunar iDXA Bone Densitometers Due to Radiation Risk

    GE Healthcare is recalling 123 Lunar iDXA bone densitometers because a control panel issue may cause the start button to stick, potentially leading to accidental radiation exposure.

    Product
    Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) bone densitometer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1810-2020·2020-05-06

    Welch Allyn Electrocardiographs Recalled for Defibrillation Safety Non-Compliance

    Welch Allyn is recalling 78,521 lead diagnostic electrocardiographs because they may not meet defibrillation withstand requirements.

    Product
    Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Scribe and Connex Cardio. Product Usage: A non-invasive prescription device indicated for use to acquire, analyze, display, transmit and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1812-2020·2020-05-06

    Welch Allyn H12+ Holter Recorders Recalled for Defibrillation Safety Non-Compliance

    Welch Allyn is recalling H12+ Holter Recorders and patient cables because they may not meet defibrillation withstand requirements.

    Product
    H12+ and patient cable for the H12+ Holter Recorders with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, PAT CBL 10WIRE LEADFORM XL IEC SNAP. The 24-hour H12+ recorder uses a single AA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V252000·2020-05-05

    Thomas Built Buses Recalls Saf-T-Liner HDX for Small Emergency Exit Labels

    Daimler Trucks North America is recalling 2010-2020 Thomas Built Buses Saf-T-Liner HDX school buses because the rear emergency exit window labels may have lettering that is too small to read easily.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E027000·2020-05-03

    Harbor Freight Recalls Pittsburgh Automotive 3 Ton Heavy Duty Steel Jack Stands

    Harbor Freight is recalling Pittsburgh Automotive 3 Ton Heavy Duty Steel Jack Stands because the ratchet teeth may not engage properly, causing the stand to fail under load.

    Product
    EQUIPMENT:MECHANICAL:INTEGRATED JACK/LEVELER/STABILIZER recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-05022020·2020-05-02

    Chicken Noodle Soup Recalled for Undeclared Egg Allergen

    USDA issued a public health alert for Roundy's chicken noodle soup containing undeclared egg. No illnesses have been reported.

    Product
    Roundy's Supermarkets, Inc. — FSIS Issues Public Health Alert for Chicken Noodle Soup Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·20V247000·2020-05-01

    Mercedes-Benz Recalls G-Class Vehicles Due to Child Safety Lock Label Error

    Mercedes-Benz is recalling 2019-2020 G550 and G63 vehicles because the child safety lock symbol may indicate the incorrect status, posing a risk to unrestrained children.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ G 550, G63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20740·2020-04-30

    Essential Trading Post Recalls Wintergreen and Birch Oils for Packaging Defect

    Essential Trading Post is recalling Wintergreen and Birch Essential Oils because the packaging is not child-resistant, posing a risk of poisoning to young children.

    Product
    Essential Trading Post Wintergreen and Birch Essential Oils
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·20114·2020-04-30

    Bellman & Symfon Recalls Flash Receivers for Hearing-Impaired Users

    Bellman & Symfon is recalling Flash Receivers because the backup battery may fail to charge, preventing the unit from alerting hearing-impaired users to emergencies.

    Product
    Flash Receivers
    Category
    Consumer Product
    Distribution
    Distributed nationwide