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.

35226–35250 of 50504

  • HighFDA (Drugs)·D-1097-2016·2016-07-13

    Reliable Drug Recalls Compounded Hydrocortisone Products Due to Processing Controls

    Reliable Drug is recalling all compounded hydrocortisone products due to a lack of processing controls. The recall covers products distributed in California, Hawaii, and New Mexico.

    Product
    All hydrocortisone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Food)·F-1614-2016·2016-07-13

    Sid Wainer & Son Recalls Tart Shells for Undeclared Coconut Allergen

    Sid Wainer & Son is recalling Domaine de Provence Neutral 3" Cone Tart Shells because they contain undeclared coconut, a major food allergen.

    Product
    Domaine de Provence Neutral 3"¿ Cone Tart Shells Produced Exclusively for Sid Wainer & Son, New Bedford, MA UPC Code: 708152316856 Item Number: 316850
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-2124-2016·2016-07-13

    Esaote G-scan Brio MRI System Recalled for Table Fracture Risk

    Esaote S.p.A. is recalling G-scan Brio MRI systems because dynamic loading forces from larger patients can fracture the patient table's extremity portion.

    Product
    Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Food)·F-1602-2016·2016-07-13

    Grain Craft Donut Flour Recalled for Possible Peanut Protein Contamination

    Grain Craft, Inc. is recalling Donut Flour due to possible peanut protein contamination. The product was distributed to nine states.

    Product
    Donut Flour, Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Drugs)·D-1131-2016·2016-07-13

    Reliable Compounding Pharmacy Recalls All Compounded Tacrolimus Products

    Reliable Compounding Pharmacy is recalling all compounded tacrolimus products due to a lack of processing controls. The recall covers products distributed in California, Hawaii, and New Mexico.

    Product
    All tacrolimus Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Food)·F-1603-2016·2016-07-13

    Grain Craft Graham Recalled for Possible Peanut Protein Contamination

    Grain Craft is recalling 50-pound bags of Graham due to possible peanut protein contamination. The product was distributed to nine states.

    Product
    Graham, Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-1605-2016·2016-07-13

    Grain Craft Pastry Flour Recalled for Possible Peanut Protein Contamination

    Grain Craft, Inc. is recalling specific lots of 50-lb pastry flour due to possible peanut protein contamination. The product was distributed to nine states.

    Product
    Pastry Flour (BRMOO20, M1633, 825, R000110690), Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Drugs)·D-1118-2016·2016-07-13

    Reliable Compounding Pharmacy Recalls Diltiazem Products Due to Processing Controls

    Reliable Compounding Pharmacy is recalling all diltiazem products compounded between March 2015 and March 2016 due to a lack of processing controls.

    Product
    All diltiazem Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Food)·F-1604-2016·2016-07-13

    Grain Craft Unenriched Pastry Flour Recalled for Possible Peanut Contamination

    Grain Craft, Inc. is recalling specific lots of Unenriched Pastry Flour due to possible peanut protein contamination. The product was distributed to nine states.

    Product
    Unenriched Pastry Flour, (M1613, R100258001), Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-1600-2016·2016-07-13

    Kraft Cake Flour Recalled for Possible Peanut Protein Contamination

    Grain Craft, Inc. is recalling 50 lb. bags of Kraft Cake Flour due to possible peanut protein contamination. The product was distributed to nine states.

    Product
    Kraft Cake Flour (110760), Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2131-2016·2016-07-13

    GE Healthcare Recalls Discovery MR750w MRI Scanners Due to Burn Risk

    GE Healthcare is recalling 471 Discovery MR750w MRI scanners because a small area of the patient bore can become warm enough to cause a serious burn if proper padding is not used.

    Product
    GE Healthcare, Discovery MR750w
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-2129-2016·2016-07-13

    Medtronic PoleStar MRI System Components Recalled for Electrical Shock Risk

    Medtronic Navigation is recalling PoleStar MRI system components due to misplaced ground pins that may cause electrical shock to users.

    Product
    PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex Chiller Product The PoleStar Surgical MRI System is intended for use as an intraoperative imaging device to produce MRI images of sections of the head selected by the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2082-2016·2016-07-13

    Medtronic 0-arm Imaging mobile x-ray system recall for battery damage risk

    Medtronic is recalling 0-arm Imaging mobile x-ray systems because replacement batteries may be damaged during shipment, creating a risk of failure.

    Product
    Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1598-2016·2016-07-13

    Grain Craft Cake Flour Recalled for Possible Peanut Contamination

    Grain Craft is recalling 50-pound bags of Craft Cake Flour due to possible peanut protein contamination. The product was distributed to nine states.

    Product
    Craft Cake Flour (M4138), Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2135-2016·2016-07-13

    Toshiba Vantage Titan 3T MRI System Recalled for Gradient Coil Issue

    Toshiba American Medical Systems is recalling 33 Vantage Titan 3T MRI systems due to a potential problem with the gradient coil.

    Product
    MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System Product Usage: Vantage Titan 3T (MRT-3010, M-Power V3.5) is an open-bore 3T MRI system that permits outstanding image quality without compromising on features or performance. Vantage Titan 3T combines the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2130-2016·2016-07-13

    Custom Ultrasonics System 83 Plus Endoscope Washer Recall Issued

    Custom Ultrasonics is recalling System 83 Plus endoscope washer/disinfectors to warn customers not to use them for duodenoscopes until further notice.

    Product
    The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2123-2016·2016-07-13

    Medtronic Recalls Cytosponge Cell Collection Device Due to Detachment Reports

    Medtronic is recalling the Cytosponge Cell Collection Device after two reports of the device detaching from its removal string during withdrawal from the esophagus.

    Product
    Covidien Cytosponge Cell Collection Device. Item code CYTO-101-01. Gastroenterology: -.Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. This device is currently only being used in clinical studies.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Food)·F-1599-2016·2016-07-13

    Grain Craft Recalls Kraft Cake Flour Due to Possible Peanut Contamination

    Grain Craft, Inc. is recalling 50-pound bags of Kraft Cake Flour due to possible peanut protein contamination. The product was distributed to nine states.

    Product
    Kraft Cake Flour (110760), Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2125-2016·2016-07-13

    Medtronic Recalls MyCareLink Patient Monitor Due to Data Transmission Failure

    Medtronic is recalling 262 MyCareLink Patient Monitors because a software update prevents implanted device data from reaching clinicians, despite appearing successful to patients.

    Product
    Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitoring system that interrogates implanted devices and transmits the data to the Care Link Network for viewing by the physician.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1601-2016·2016-07-13

    Grain Craft Recalls Bojangles Chicken Breading Flour for Peanut Contamination

    Grain Craft, Inc. is recalling Bojangles Chicken Breading Flour due to possible peanut protein contamination. The product was distributed to nine states.

    Product
    Bojangles Chicken Breading Flour (12248), Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.
    Category
    Food
    Distribution
    9 states