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.

40751–40775 of 50511

  • HighCPSC·14245·2014-07-31

    Dynacraft Recalls Avigo Youth Bicycles Due to Front Wheel Detachment Hazard

    Dynacraft is recalling Avigo 20-inch youth bicycles because the front wheel can detach, posing a fall hazard. One injury involving scrapes and abrasions has been reported.

    Product
    Avigo 20-inch Turn N' Burn Youth Bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V468000·2014-07-31

    Jayco Recalls 2014-2015 White Hawk Travel Trailers Due to Tire Wear

    Jayco is recalling 2014-2015 White Hawk Summit 27RBOK travel trailers because a tire may rub against the outrigger, causing premature wear or failure.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER, JAYCO WHITE HAWK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V466000·2014-07-31

    Entegra Recalls 2014-2015 Cornerstone Motorhomes for Seat Belt Defect

    Entegra is recalling 2014-2015 Cornerstone motorhomes because incorrect seat belt attachments may cause fraying and reduced strength, increasing injury risk in crashes.

    Product
    ENTEGRA — ENTEGRA CORNERSTONE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2116-2014·2014-07-30

    Pentax Ultrasound Gastroscopes Recalled Due to Aspiration Needle Derailment Risk

    Pentax Medical is recalling 531 ultrasound gastroscopes because aspiration needles may derail from the accessory elevator, posing a risk of patient injury.

    Product
    EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2198-2014·2014-07-30

    Metagenics Recalls UltraBalance Protein Powder for Undeclared Soy

    Metagenics is recalling UltraBalance Protein Powder because it may contain undeclared soy. The recall covers specific lots distributed nationwide and internationally.

    Product
    UltraBalance Protein Powder, Net Wt. 14.8 oz (420g)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2115-2014·2014-07-30

    Heartsine AED Electrode Pouches Recalled for Difficulty Opening

    Heartsine is recalling Pad-Pak and Pedi-Pak electrode accessories for the Samaritan PAD 300P and 350P because some sealed foil pouches are difficult to open, potentially delaying therapy.

    Product
    Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibrillator electrode supplies. The Pedi-Pak is specifically designed for use with the HeartSine Samaritan PAD 300P and 350P device. It contains…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2100-2014·2014-07-30

    Terumo Recalls Sarns Two-stage Venous Return Cannulae Due to Particulate

    Terumo CVS is recalling Sarns Two-stage Venous Return Cannulae because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flare or connector Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2219-2014·2014-07-30

    Land O'Lakes Recalls Cheese Spread Due to Plastic Contamination

    Land O'Lakes is recalling specific lots of Golden Velvet Pasteurized Process Cheese Spread due to potential contamination with large pieces of plastic.

    Product
    Item: 48775 Land O'Lakes, Golden Velvet Pasteurized Process Cheese Spread - Yellow, NET WT 5 LBS (2.26 KG)
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2109-2014·2014-07-30

    Philips QLAB 10 Core Module Software Recall for Measurement Defect

    Philips Ultrasound is recalling QLAB 10 Core Module software due to a defect that may use incorrect measurement values under specific conditions.

    Product
    QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2114-2014·2014-07-30

    GE Healthcare Recalls CARESCAPE Monitor B650 Due to Sound Loss

    GE Healthcare is recalling CARESCAPE Monitor B650 units because they may lose alarm sounds when an external display is connected via a USB extender with an active hub.

    Product
    GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2108-2014·2014-07-30

    Teleflex Recalls Hudson RCI Breathing Circuits Due to Temperature Probe Defect

    Teleflex Medical is recalling Hudson RCI breathing circuits because the temperature probe does not properly connect to the temperature port.

    Product
    Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece), Rx Only, Single Patient Use. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a…
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-2089-2014·2014-07-30

    Perouse Flamingo Inflation Devices Recalled for Potential Water-Tightness Defect

    Perouse Medical is voluntarily recalling specific batches of Flamingo Inflation Devices due to a potential water-tightness defect that could allow air entry during cardiovascular procedures.

    Product
    Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2082-2014·2014-07-30

    DePuy RECLAIM Taper Protector Sleeve Recalled for Removal Difficulty

    DePuy Orthopaedics is recalling 814 RECLAIM Taper Protector Sleeves because the product can be difficult to remove from the Distal Stem.

    Product
    RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
    Category
    Medical Device
    Distribution
    49 states
  • HighNHTSA·14V563000·2014-07-30

    Honda Recalls 2015 Fit Vehicles Due to Incorrect A-Pillar Cover

    Honda is recalling 2015 Fit vehicles because an incorrect A-pillar cover may impair side curtain air bag performance, increasing injury risk in a crash.

    Product
    HONDA — HONDA FIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2085-2014·2014-07-30

    GE Healthcare CARESCAPE Patient Monitors Recalled for Data Loss

    GE Healthcare is recalling CARESCAPE B850, B650, and B450 patient monitors because the Patient Data Module may fail to communicate, causing partial loss of monitoring parameters.

    Product
    GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2111-2014·2014-07-30

    Siemens syngo Imaging XS Software Recall for Potential Miscalculation

    Siemens is recalling syngo Imaging XS software due to potential miscalculation of grey scale values in specific image processing functions.

    Product
    Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2091-2014·2014-07-30

    Invacare Recalls M41 Wheelchair Controllers Due to Programming Error

    Invacare is recalling 819 M41 powered wheelchair controllers that may cause momentary loss of control due to non-standard factory programming.

    Product
    MK5 NX Controller--Wheelchair controller
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2096-2014·2014-07-30

    Terumo Recalls Sarns Venous Return Cannulae Due to Loose Fiber Particulate

    Terumo CVS is recalling Sarns Malleable Dual-stage Venous Return Cannulae because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2" connector with or without Xcoating Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2205-2014·2014-07-30

    Wegmans Ice Bags Recalled Due to Potential Metal Contamination

    Wegmans Food Markets is recalling 7 lb and 18 lb bags of ice because they may contain metal pieces from a broken ice machine part.

    Product
    WEGMANS ICE in plastic bags; NET WT. 7 LBS (UPC 77890 29197) and NET WT 18 LBS (UPC 77890 29200) --- WEGMANS FOOD MARKETS INC. ROCHESTER, NEW YORK
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2092-2014·2014-07-30

    Alphatec Spine Recalls Solanas 2.1mm Fixed Depth Drill

    Alphatec Spine is recalling 14 units of the Solanas 2.1mm Fixed Depth Drill because the golden stop slid from its fixed position during use.

    Product
    Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior Stabilization System, a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2099-2014·2014-07-30

    Terumo Recalls Sarns Soft-Flow Aortic Cannulae Due to Fiber Particulate

    Terumo CVS is recalling Sarns Soft-Flow Aortic Cannulae because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
    Category
    Medical Device
    Distribution
    Distributed nationwide