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.

23251–23275 of 50435

  • HighNHTSA·20V262000·2020-05-08

    Ford Recalls 2020 Expedition and Navigator for Pre-Collision Assist Defect

    Ford is recalling 2020 Expedition and Lincoln Navigator vehicles because the Pre-Collision Assist feature is not enabled due to incorrect coding, increasing crash risk.

    Product
    FORD — FORD, LINCOLN EXPEDITION, NAVIGATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V263000·2020-05-08

    Ford Recalls 2019-2020 Mustang and 2019 Expedition for Warning Defect

    Ford is recalling 2019-2020 Mustang and 2019 Expedition vehicles because the 'Transmission Not In Park' warning is shorter than intended, which may increase the risk of unintended vehicle movement.

    Product
    FORD — FORD MUSTANG, EXPEDITION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E030000·2020-05-08

    McNeilus Recalls CNG Fuel Systems with Defective Pressure Relief Devices

    McNeilus is recalling certain CNG fuel systems sold as aftermarket parts because the pressure relief devices may fail to vent during heat exposure, potentially causing the system to rupture.

    Product
    FUEL SYSTEM, OTHER:STORAGE:TANK ASSEMBLY:PRESSURE RELIEF DEVICES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20741·2020-05-07

    Sobeauty Recalls Mag Cube Magnetic Ball Sets Due to Ingestion Risk

    Sobeauty is recalling Mag Cube magnetic ball sets because the small, high-powered magnets pose a serious risk of intestinal injury or death if swallowed by children.

    Product
    Mag Cube magnetic ball sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·20119·2020-05-07

    Noah Clothing Recalls Men's Reverse Fleece Hoodies for Burn Hazard

    Noah Clothing is recalling men's reverse fleece hoodies because they fail federal flammability standards, posing a burn risk. No injuries have been reported.

    Product
    Noah Reverse Fleece Hoodies
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·20118·2020-05-07

    Poppin' Cobs Microwave Popcorn Recalled for Fire and Burn Hazards

    Fully Popped is recalling Poppin' Cobs 10 Pack Microwave Popcorn because the paper bags can catch fire in the microwave, posing fire and burn hazards.

    Product
    Poppin' Cobs 10 Pack Microwave Popcorn
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1814-2020·2020-05-06

    Welch Allyn X12+ Telemeter and Patient Cable Recall for Defibrillation Safety

    Welch Allyn is recalling X12+ Telemeters and patient cables because they may not meet defibrillation withstand requirements.

    Product
    X12+ and patient cable for the X12+ Telemeter 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, PAT CBL 4WIRE AHA SNAP HC.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1809-2020·2020-05-06

    Philips Azurion 7 M20 XperGuide Software Recall for Incorrect Overlay Display

    Philips is recalling Azurion 7 M20 systems with XperGuide software because a software defect may display incorrect needle paths if the L-arm is mispositioned.

    Product
    Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluoroscopic x-ray system System code: 722079
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Food)·F-0922-2020·2020-05-06

    Tops Mint Dark Chocolate Bars Recalled for Undeclared Milk

    Tops Markets is recalling Mint Flavor Pure Dark Chocolate bars because they contain undeclared milk, a major allergen.

    Product
    Tops Mint Flavor Pure Dark Chocolate 45% Cocoa NET WT 3.5 oz.(100g)
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1821-2020·2020-05-06

    Alcon Air Optix Night & Day Aqua Contact Lenses Recalled for Counterfeit Concerns

    Allied Vision Group is recalling specific lots of Alcon Air Optix Night & Day Aqua contact lenses because potentially counterfeit products and packaging were imported to the U.S.

    Product
    Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1802-2020·2020-05-06

    Stryker Recalls 90 Reprocessed Zimmer Tourniquet Cuffs Due to Mislabeling

    Stryker Sustainability Solutions is recalling 90 reprocessed Zimmer tourniquet cuffs because they are potentially mislabeled. The mislabeling could lead to device misuse or inadequate limb compression during surgery.

    Product
    Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI: 00885825013868, Reprocessed Tourniquet Cuff - Product Usage: Reprocessed tourniquet cuffs are indicated for use in patients who require surgery of the extremities with an expected…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0929-2020·2020-05-06

    Frozen Flounder Stuffed with Seafood Recalled for Undeclared Milk

    Freedman Food Service is recalling frozen flounder stuffed with seafood because the product may contain undeclared milk.

    Product
    7075931 Flounder Stuffed W/ Seafood FRZN, Net Wt LBS 15.00 (6.80 KG), 20 packages per case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1801-2020·2020-05-06

    Philips Azurion 7 M20 X-Ray System Recalled for Loose Screw Risk

    Philips is recalling 162 Azurion 7 M20 angiographic X-ray systems because unspecified torque on C-arm roll motor screws could cause them to become loose.

    Product
    Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1710-2020·2020-05-06

    GE Healthcare Recalls Lunar iDXA Advance Bone Densitometers Due to Radiation Risk

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

    Product
    Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1803-2020·2020-05-06

    ViewRay MRIdian TPDS Software Recalled for Dose Alignment Errors

    Viewray, Inc. is recalling 32 units of MRIdian TPDS software due to a defect that may cause incorrect dose calculations during treatment planning.

    Product
    ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1811-2020·2020-05-06

    Welch Allyn ELI PC Service Recalled for Defibrillation Safety Non-Compliance

    Welch Allyn is recalling ELI PC Service software because it may not meet defibrillation withstand safety requirements for medical electrical equipment.

    Product
    ELI PC. The ELI PC Service automatically converts resting ECG recordings collected with WAM PC patient cables and WebUpload into DICOM 12-lead ECG Waveform files.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1808-2020·2020-05-06

    Uromedica Recalls ProACT Implantation Instrument Sets Due to Sheath Defects

    Uromedica Inc. is recalling 11 ProACT Implantation Instrument Sets because defective U-channel sheaths may damage ProACT implant devices during use.

    Product
    ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro ACT balloon implant is introduced.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1712-2020·2020-05-06

    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 Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1824-2020·2020-05-06

    Kerr Nexus Universal Trial Kits Recalled for Incorrect Bonding Agent

    Kerr/Pentron is recalling 111 trial kits of Nexus Universal with OptiBond Universal due to a packaging error that included the incorrect bonding agent, potentially increasing the risk of bond failures.

    Product
    Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref # 36990 - Product Usage: The intended use of this device is to be used for the cementation of indirect restorations including veneers, inlays, onlays, bridges, posts, and the cementation of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1799-2020·2020-05-06

    Beckman Coulter Recalls Barbiturates Reagent Due to Potential Test Inaccuracy

    Beckman Coulter is recalling SYNCHRON Systems Barbiturates Reagent because cross-reactivity testing may not meet claims, potentially causing false positive or negative results.

    Product
    SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1816-2020·2020-05-06

    Welch Allyn Surveyor S12 and S19 Patient Monitors Recalled for Defibrillation Safety

    Welch Allyn is recalling 78,521 Surveyor S12 and S19 bedside monitors and patient cables because they may not meet defibrillation withstand safety requirements.

    Product
    Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the following device names: PAT CBL 10WIRE AHA SNAP JSCREW, PAT CBL 10WIRE IEC SNAP JSCREW. The Surveyor S12 patient monitor is designed for continuous monitoring in either stationary or portable…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1835-2020·2020-05-06

    ICU Medical Cogent Hemodynamic Monitoring System Recalled for Software Issues

    ICU Medical is recalling 83 Cogent Hemodynamic Monitoring Systems due to software issues that may cause inaccurate data, unit shutdown, or loss of display.

    Product
    ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
    Category
    Medical Device
    Distribution
    Distributed nationwide