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.

42501–42525 of 50511

  • HighFDA (Devices)·Z-0281-2014·2013-11-20

    Ray Station Radiation Therapy System Recalled for Dose Calculation Error

    Ray Search Laboratories is recalling Ray Station 3.0, 3.5, and 4.0 systems due to a dose calculation error involving Elekta motorized wedges.

    Product
    Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Food)·F-0169-2014·2013-11-20

    Oh Bok Bakery Recalls Doughnuts for Undeclared Wheat Allergen

    Cho & So, Inc. DBA Oh Bok Bakery is recalling ASSI brand Korean Cake doughnuts because wheat flour was not declared on the label.

    Product
    Doughnuts packed on styrofoam tray with plastic over wrap ASSI brand Korean Cake 20645D Net Wt.: 8 oz. Distributed by Rhee Bros., Inc. 7461 Coca Cola Dr Hanover, MD 21076 Expiration date 1/29/14 With Korean language labeling
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0196-2014·2013-11-20

    Terumo Recalls Sarns Venous Return Cannulae Due to Particulate

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

    Product
    Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long. Indicated for venous drainage during cardiopulmonary bypass surgery for dial cannulation of the superior and inferior vena cava.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0278-2014·2013-11-20

    Medtronic RestoreUltra and RestoreSensor Neurostimulators Recalled for Loss of Stimulation

    Medtronic is recalling 64,163 RestoreUltra and RestoreSensor neurostimulators worldwide due to a risk of loss of stimulation when switching program groups.

    Product
    Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0182-2014·2013-11-20

    Urologix Recalls Prostiva RF Therapy Hand Piece Kits Due to Deployment Force Issue

    Urologix is recalling 142 Prostiva RF Therapy Hand Piece Kits because the hand piece deployment force exceeded maximum specifications.

    Product
    Prostiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethylene Oxide. The Prostiva RF Model 8929 Hand Piece Kit is the delivery system component of the Prostiva RF Therapy System. Prostiva RF Therapy delivers low-levels of radiofrequency (RF) energy directly…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0192-2014·2013-11-20

    DePuy Mitek FMS Outflow Tubing Recalled Due to Valve Malfunction

    DePuy Mitek is recalling FMS Outflow Tubing because the pillow valve may not perform as intended, potentially leading to backflow of irrigation fluid and patient cross-contamination.

    Product
    DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Product Usage: The Intermediary Tubing for FMS¿ Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0284-2014·2013-11-20

    Hospira Recalls Plum A+ Infusion Systems Due to Broken Pressure Sensor Pin

    Hospira is recalling 10,669 Plum A+ Infusion Systems because the distal pressure sensor pin may break. This defect can prevent the device from detecting occlusions in the administration set.

    Product
    The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0275-2014·2013-11-20

    DeRoyal Surgical Eye Spears Recalled for Incorrect X-Ray Detectability Labeling

    DeRoyal Industries is recalling one lot of Surgical Eye Spears because they were labeled as x-ray detectable but contained non-detectable product.

    Product
    DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, MADE IN GUATEMALA cleaning of fluids from surgical site in or near the eye
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0282-2014·2013-11-20

    Draeger Ceiling Supply Units Recalled Due to Broken Drive Screw

    Draeger Medical is recalling 139 Movita 603x/DVE 803x Ceiling Supply Units because a broken drive screw caused the lift arm to fall.

    Product
    Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0270-2014·2013-11-20

    GE Healthcare Recalls AW Workstations Due to Image Orientation Error

    GE Healthcare is recalling AW VolumeShare and AW Server software due to a potential safety issue where images may display in the wrong orientation after rotation.

    Product
    AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0291-2014·2013-11-20

    Beckman Coulter Recalls Access 2 Immunoassay System Due to Fuse Defect

    Beckman Coulter is recalling the Access 2 Immunoassay System because the fuses may have the wrong amperage.

    Product
    Access 2 Immunoassay System, Part Number: 81600N The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V578000·2013-11-20

    Mirage Cargo Trailer Recall for Door Lock Jamming Risk

    Mirage is recalling 2006-2013 cargo trailers with Fastec door locks that may jam, potentially trapping occupants inside.

    Product
    MIRAGE — MIRAGE CARGO TRAILERS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0203-2014·2013-11-20

    Hospira Recalls Plum A+ Hyperbaric Infusion Pumps Due to Calibration Drift

    Hospira is recalling 179 Plum A+ Hyperbaric Infusion Pumps because distal pressure sensor calibration drift may cause false alarms or occlusions.

    Product
    Plum A+ Hyperbaric Infusion Pump; List Number 11005; Labeled in part: PLUM A+ HYPERBARIC; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0204-2014·2013-11-20

    Infusion pumps are recalled for distal pressure sensor drift

    Hospira recalled 10,669 Plum A+ infusion pumps after reports of distal pressure sensor calibration drift. The issue may cause false occlusion alarms or distal occlusions.

    Product
    Plum A+ Infusion Pump; List Number: 11971; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0147-2014·2013-11-20

    Empirical Labs Recalls Vive Shake Up Your Health Chocolate Dietary Supplements

    Empirical Labs is recalling specific lots of Vive Shake Up Your Health Chocolate dietary supplements due to potential adulteration with chloramphenicol.

    Product
    Vive Shake Up Your Health Chocolate; Made for and distributed by renewal wellness.
    Category
    Food
    Distribution
    3 states
  • HighNHTSA·13V580000·2013-11-20

    Fleetwood Recalls 2014 Recreational Vehicles Due to Seat Belt Latch Issues

    Fleetwood is recalling 774 model year 2014 recreational vehicles because the seat belt latch plate may remain partially engaged, making the belt difficult to unlatch.

    Product
    FLEETWOOD — FLEETWOOD, AMERICAN COACH TIOGA MONTARA, AMERICAN EAGLE, PROVIDENCE, TERRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13E064000·2013-11-20

    Seats Incorporated Recalls Front Seat Belt Buckle Assemblies

    Seats Incorporated is recalling front seat belt buckle assemblies that may fail to release when the button is pressed, increasing injury risk in a crash.

    Product
    SEAT BELTS:FRONT:BUCKLE ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0207-2014·2013-11-20

    Hospira Recalls Plum A+ Infusion Pumps Due to Pressure Sensor Calibration Drift

    Hospira is recalling 182,970 Plum A+ Infusion Pumps because pressure sensor calibration drift may cause false alarms or missed occlusions.

    Product
    Plum A+ Infusion Pump; List Number: 12391; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0290-2014·2013-11-20

    Hospira Recalls Plum A+ Infusion Systems Due to Broken Sensor Pin Risk

    Hospira Inc. is recalling Plum A+ Infusion Systems because the distal pressure sensor pin may break, potentially preventing the detection of line occlusions.

    Product
    The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0289-2014·2013-11-20

    Hospira Recalls Plum A+3 Infusion Systems Due to Broken Sensor Pin Risk

    Hospira is recalling 21,551 Plum A+3 Infusion Systems because a distal pressure sensor pin may break, potentially preventing the detection of line occlusions.

    Product
    The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral, enteral, or epidural…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0206-2014·2013-11-20

    Hospira Recalls Plum A+3 Infusion Pumps Due to Pressure Sensor Drift

    Hospira is recalling 214 Plum A+3 Infusion Pump Systems because distal pressure sensor calibration drift may cause false alarms or occlusions.

    Product
    Plum A+3 Infusion Pump System; List Number: 12348; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0159-2014·2013-11-20

    Klaire Labs Vital-Zymes Chewable Recalled for Chloramphenicol Contamination

    ProThera, Inc. is recalling Klaire Labs Vital-Zymes Chewable enzyme supplements because they may be contaminated with chloramphenicol.

    Product
    Klaire Labs Vital-Zymes Chewable; Comprehensive Enzyme Supplement; 180 Chewable tablets. UPC 7 09616 0218 5 Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera Reno, NV 89521
    Category
    Food
    Distribution
    0 states
  • HighNHTSA·13V577000·2013-11-20

    Blue Bird Recalls 2014 Vision and All American Buses for Seat Belt Defect

    Blue Bird is recalling 146 model year 2014 Vision and All American non-school buses because the driver's seat belt latch plate can become stuck, hindering egress.

    Product
    BLUE BIRD — BLUE BIRD VISION, ALL AMERICAN
    Category
    Vehicle
    Distribution
    Distributed nationwide