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.

34876–34900 of 50502

  • HighFDA (Food)·F-1973-2016·2016-08-31

    La Torre Copito Marshmallow Chocolate Cookie Recalled for Milk Allergen Mislabeling

    La Torre Foods is recalling Copito Marshmallow Chocolate Cookies because the label lists calcium caseinate but fails to declare milk, a major allergen.

    Product
    la Torre Copito Marshmallow Chocolate Cookie NET WT 4.94 oz packaged in a cardboard box.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2642-2016·2016-08-31

    Ziehm Vision R Mobile C-arm Recalled for Radiation Warning Timer Malfunction

    Ziehm Imaging Inc is recalling one Ziehm Vision R Mobile C-arm device because its radiation-warning timer and 3D-specific interval warning malfunction, preventing alerts until the unit is rebooted.

    Product
    Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2640-2016·2016-08-31

    Ziehm Vision RFD Mot Mobile C-arm Recalled for Timer Malfunction

    Ziehm Imaging is recalling 14 mobile C-arm devices because the radiation-warning timer and 3D interval warning may fail to alert users until the unit is rebooted.

    Product
    Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2639-2016·2016-08-31

    Ziehm Vision RFD 3D Mobile C-arm Recalled for Timer Malfunction

    Ziehm Imaging Inc is recalling 31 mobile C-arm devices because the radiation-warning timer and 3D interval warning may fail to alert users until the unit is rebooted.

    Product
    Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2645-2016·2016-08-31

    Medtronic Recalls DBS Pocket Adaptors Due to Conductor Wire Fracture Risk

    Medtronic is recalling DBS Pocket Adaptors Models 64001 and 64002 due to potential conductor wire fractures. A safety notification was sent to healthcare professionals regarding device handling and integrity checks.

    Product
    DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neurostimulation system for deep brain stimulation. The pocket adaptor is intended to be implanted with the new replacement…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2599-2016·2016-08-31

    Conmed Pediatric Dual Dispersive Electrodes Recalled for Burn Risk

    Conmed is recalling 4,560 pediatric dual dispersive electrodes because they may be incompatible with some generators, risking undetected pad lift and potential burns.

    Product
    Pediatric Dual Dispersive Electrodes (for patients 5-15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC¿ generators or conventional electrosurgery units with similar contact monitoring systems…
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2658-2016·2016-08-31

    Philips Ingenuity Core128 CT Systems Recalled for Image Reconstruction Defect

    Philips is recalling three Ingenuity Core128 CT systems because a software upgrade can cause planned anatomy to be cut off in gated helical scan images.

    Product
    Ingenuity Core128, Model number 728323 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·16771·2016-08-31

    Salewa Recalls Wild Country Syncro Climbing Harnesses Due to Fall Hazard

    Salewa North America is recalling Wild Country Syncro climbing harnesses because excess materials on the waist belt tab can cause the harness to loosen, posing a fall hazard.

    Product
    Wild Country Syncro Harnesses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1968-2016·2016-08-31

    English Bay Cinnamon Rolls Recalled for Allergen Labeling Error

    English Bay Batter Inc is recalling cinnamon rolls because the packaging states 'May Contain Milk' instead of 'Contains Milk'.

    Product
    CINNAMON ROLLS WITH CREAM CHEESE ICING Quality & Value pics BY PRICE CHOPPER NET WT 12.4 OZ (351g) INGREDIENTS: ***CREAM CHEESE (PASTEURIZED MILK AND CREAM, CHEESE CULTURES***. CONTAINS WHEAT. MAY CONTAIN MILK, EGGS, SOY, PEANUTS AND TREE NUTS. DISTRIBUTED BY: PRICE CHOPPER…
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1948-2016·2016-08-31

    Montana Flour & Grains Recalls Organic Spelt Grain for Wheat Mislabeling

    Montana Flour & Grains is recalling 100% Organic Spelt Grain because the label fails to declare wheat, a major allergen.

    Product
    100% Organic Spelt Grain, packaged in 10 lbs., 25 lbs. and 50 lbs paper bags, bulk container.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1462-2016·2016-08-31

    Talon Compounding Pharmacy Recalls Human Chorionic Gonadotropin Injection Due to Sterility Concerns

    Talon Compounding Pharmacy is recalling 6,500 vials of Human Chorionic Gonadotropin Injection nationwide due to a lack of assurance of sterility.

    Product
    Human Chorionic Gonadotropin Injection (a) 2500 iu, (b) 2500 iu with B12, (c) 3500 iu, (d) 5000 iu, (e) 5000 iu with B12, (f) 6000 iu, (g) 7500 iu, (h) 7500 iu with B12, (i)11,000 iu, (j)11,000 iu with B12, (k) 15,000 iu, (l) 20,000 iu, (m) 20,000 iu with B12, 10 mL sterile…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2595-2016·2016-08-31

    Conmed Dual Dispersive Electrodes Recalled for Burn Risk

    Conmed is recalling Adult ThermoGard Dual Dispersive Electrodes because they may be incompatible with some electrosurgical generators, posing a risk of undetected pad lift and potential burns.

    Product
    Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), 10' (3.05m) Cable, Catalog Number 51-7310. Intended to be used for the dispersion and return to the electrosurgical generator.
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2602-2016·2016-08-31

    Medtronic Recalls DBS Lead Kits Due to Potential Insulation Damage

    Medtronic is voluntarily recalling 70 unused DBS lead kits from three lots due to potential insulation damage identified during manufacturing.

    Product
    Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
    Category
    Medical Device
    Distribution
    10 states
  • HighNHTSA·16V631000·2016-08-31

    Thomas Built Buses Recall Wheelchair Lifts Due to Bearing Defect

    Daimler Trucks is recalling 2015-2017 Thomas Built Buses equipped with certain Ricon wheelchair lifts because pivot holes may allow bearings to move, risking platform failure.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2, SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V633000·2016-08-31

    Peterbilt 567 Truck Recalled for Tripping Hazard on Left Rail

    PACCAR is recalling one 2017 Peterbilt 567 truck because a bracket protrudes upward, creating a tripping hazard. Dealers will move the connections to the right rail free of charge.

    Product
    PETERBILT — PETERBILT 567
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2648-2016·2016-08-31

    Bovie Precise 360 Handpiece Recalled for Incomplete Adhesive Bond

    Bovie Medical Corporation is recalling 95 units of the BVX-450BR Bovie Precise 360 Handpiece because the adhesive bond to the angled tip may be incomplete.

    Product
    BVX-450BR Bovie Precise 360 Handpiece 45cm, blade Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V629000·2016-08-31

    Thomas Built Buses Recall Wheelchair Lifts Due to Bearing Defect

    Daimler Trucks North America is recalling 2015-2017 Thomas Built Buses equipped with specific Ricon wheelchair lifts. Defective pivot holes may allow bearings to move, causing the lift platform to fall and injure the operator.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX, SAF-T-LINER EFX, MINOTOUR, SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2643-2016·2016-08-31

    Ziehm Solo Mobile C-arm Recalled for Radiation Warning Timer Malfunction

    Ziehm Imaging Inc is recalling 12 Ziehm Solo Mobile C-arms because the radiation-warning timer and 3D-specific interval warning may fail to alert users until the unit is rebooted.

    Product
    Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2638-2016·2016-08-31

    Medtronic Recalls Alpha Total Knee Replacement Tibial Tray Components

    Medtronic is recalling specific Alpha total knee replacement tibial trays that may not have been passivated according to manufacturing requirements.

    Product
    TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2608-2016·2016-08-31

    Richard Wolf Conical Portio Adapter Recall Due to Weld Defect

    Richard Wolf Medical Instruments Corp. is recalling specific batches of Conical Portio Adapters because an improper weld may cause the device to separate during use.

    Product
    Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological laparoscopy, to determine patency of the fallopian tubes.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2634-2016·2016-08-31

    Medtronic Recalls Alpha Total Knee Replacement Components for Passivation Defect

    Medtronic Sofamor Danek USA Inc is recalling four units of Alpha total knee replacement femoral components that may not have been passivated according to requirements.

    Product
    RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 3L, REF 90-SRK-312300, QTY: 1, STERILE R,
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2635-2016·2016-08-31

    Medtronic Recalls Tibial Tray Components Due to Passivation Defect

    Medtronic is recalling three units of tibial tray components for total knee replacement because they may not have been passivated correctly.

    Product
    TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2604-2016·2016-08-31

    Innokas Medical Recalls CARESCAPE VC150 Vital Signs Monitors for Software Error

    Innokas Medical Oy is recalling 1,715 CARESCAPE VC150 Vital Signs Monitors because a software error may provide incorrect time data to measurements.

    Product
    CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.
    Category
    Medical Device
    Distribution
    15 states