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.

26676–26700 of 50462

  • HighFDA (Devices)·Z-0652-2019·2018-12-26

    Ortho-Clinical Diagnostics Recalls VITROS 3600 Immunodiagnostic System Software

    Ortho-Clinical Diagnostics is recalling VITROS 3600 Immunodiagnostic System units due to a software anomaly that may incorrectly extend reagent stability time.

    Product
    VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0639-2019·2018-12-26

    bioMerieux Recalls VITEK 2 Systems Software Version 9.01 Update Kit

    bioMerieux is recalling VITEK 2 Systems Software Version 9.01 Update Kits because they may display incorrect organism identification and antimicrobial susceptibility testing results.

    Product
    VITEK¿ 2 Systems Software Version 9.01 Update Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0743-2019·2018-12-26

    ASK Foods Recalls Smokey Mozzarella Pasta Salad Due to Contamination Risk

    ASK Foods Inc. is recalling 4 lb. bulk containers of Smokey Mozzarella Pasta Salad due to potential contamination with Listeria monocytogenes or Salmonella.

    Product
    ASK Foods Inc. Smokey Mozzarella Pasta Salad, 4 lb. Bulk Container sold from the deli and to food service accounts
    Category
    Food
    Distribution
    20 states
  • HighFDA (Food)·F-0746-2019·2018-12-26

    ASK Foods Firecracker Slaw Recalled for Listeria and Salmonella Contamination

    ASK Foods Inc. is recalling Firecracker Slaw due to potential contamination with Listeria monocytogenes or Salmonella. The product was sold in bulk containers from delis in multiple states.

    Product
    ASK Foods Inc. Naturally Creative Firecracker Slaw, 3.75 lb. Bulk Container sold from the deli
    Category
    Food
    Distribution
    20 states
  • HighFDA (Food)·F-0744-2019·2018-12-26

    ASK Foods Rigatoni Casserole Recalled for Listeria and Salmonella Risk

    ASK Foods Inc. is recalling Rigatoni Casserole due to potential contamination with Listeria monocytogenes or Salmonella.

    Product
    ASK Foods Inc. Rigatoni Casserole, 5 lb. Aluminum Tray Pan sold on Hot Bar at Retailer
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-0645-2019·2018-12-26

    Deerfield Imaging Recalls IMRIS T2X Tables Due to Roll Position Drift

    Deerfield Imaging is recalling 15 IMRIS T2X tables because they may drift in the roll position while in use.

    Product
    IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d) 109682-600, (e) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0747-2019·2018-12-26

    Mariner Seafood Recalls Farmed Coho Salmon for Listeria Contamination

    Mariner Seafood, LLC is recalling specific lots of Farmed Coho Salmon because testing confirmed the presence of Listeria monocytogenes. The product was distributed in California and New Jersey.

    Product
    Salmon packaged in a plastic container; HELLO QUALITY PACIFIC SILVERSIDE SALMON Hello FRESH NET WT. 10oz (283g) with Case Label: keep Frozen (0F or below) FARMED COHO SALMON 10 oz (283g) 2 X 5 oz portions.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0648-2019·2018-12-26

    Deerfield Imaging Recalls IMRIS ORT 300 Operating Room Tables

    Deerfield Imaging is recalling 14 IMRIS ORT 300 operating room tables because they may drift in the roll position while in use.

    Product
    IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000, (b) 114093-006 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0657-2019·2018-12-26

    Howmedica Recalls Reliance LITe Nerve Hooks Due to Shape Defects

    Howmedica Osteonics Corp. is recalling 39 units of Reliance LITe Nerve Hooks because the probes have incorrect shapes, including flat surfaces and sharp edges.

    Product
    Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blunt probe can be used as a conventional means of achieving nerve retraction. The bend at the proximal tip of the ring the discectomy, as well as during the insertion of an IBD during a conventional TLIF…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0659-2019·2018-12-26

    Konica Minolta Recalls 151 X-Ray Systems Due to Unintentional Movement

    Konica Minolta is recalling 151 Advanced Universal U-Arm 4000 X-ray systems because the U-Arm may move unintentionally.

    Product
    Bucky Stand SU-4000 Input 2017.11.17. SU41711085 Date: 2017-11-17; Board Name; Board Version, Firmware Version Advanced Universal U-Arm 4000 System. The Positioner consists of the following associated subassemblies: Vertical Column, Swivel Arm with variable height, X-ray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V932000·2018-12-26

    Spartan Metrostar and Gladiator Fire Apparatus Brake Recall

    Spartan is recalling 2011-2019 Metrostar and Gladiator fire apparatus vehicles due to a brake release delay that may hinder movement and increase crash risk.

    Product
    SPARTAN — SPARTAN METROSTAR, GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0629-2019·2018-12-26

    Jarvik 2000 Ventricular Assist System External Cables Recalled for Connector Damage

    Jarvik Heart Inc is recalling 274 external cable components for the Jarvik 2000 Ventricular Assist System due to potential damage to male connectors.

    Product
    Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, JHI-202 Lithium-ion Battery Cable, JHI-204 Extensions Cable, JHI-201 Pedestal Cable
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-0741-2019·2018-12-26

    Wegmans Roasted Corn and Bean Salad Recalled for Listeria and Salmonella

    ASK Foods Inc is recalling Wegmans Roasted Corn and Bean Salad due to potential contamination with Listeria monocytogenes or Salmonella.

    Product
    Wegmans Roasted Corn and Bean Salad; 13 oz. Plastic Container, 40 oz. Plastic Container, 4.5 lb. Plastic Bulk Container
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-0649-2019·2018-12-26

    Foundation Medicine Recalls 800 FoundationOne CDx Test Reports

    Foundation Medicine is recalling 800 FoundationOne CDx test reports because an incorrect result for a single analyte may have been reported.

    Product
    FoundationOne CDx Test Results
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0731-2019·2018-12-26

    Turkey Hill Vanilla Bean Ice Cream Recalled for Unlabeled Soy

    Harris Teeter is recalling Turkey Hill Vanilla Bean Ice Cream because some containers contained Cotton Candy Ice Cream with unlabeled soy lecithin.

    Product
    TURKEY HILL Vanilla Bean Premium Ice Cream #501 3 GAL (11.36L) paper carton CONTAINS: MILK Distributed By: Turkey Hill Dairy 2601 River Rd. Conestoga, PA 17618, call 1-800-MY DAIRY or www.turkeyhill.com, Mfd. at plant #37-087, UPC 0 20735 13520 4
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0745-2019·2018-12-26

    ASK Foods Roasted Corn and Edamame Salad Recalled for Contamination

    ASK Foods Inc. is recalling 278 cases of Roasted Corn and Edamame Salad due to potential contamination with Listeria monocytogenes or Salmonella.

    Product
    ASK Foods Inc. Naturally Creative, Roasted Corn and Edamame Salad, 4 lb. Bulk Container sold from the deli
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-0619-2019·2018-12-26

    ICU Medical Recalls Sapphire Epidural Sets Due to Occlusion Alarms

    ICU Medical is recalling 31,050 units of Sapphire Epidural Sets due to reports of distal occlusion alarms during use.

    Product
    SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space. Sets are intended for use with Sapphire Infusion Systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0647-2019·2018-12-26

    Deerfield Imaging Recalls IMRIS ORT 200 Tables Due to Roll Drift

    Deerfield Imaging is recalling 14 IMRIS ORT 200 operating room tables because they may drift in the roll position while in use.

    Product
    IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b) 113821-600, (c) 114148-000, (d) 114148-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0646-2019·2018-12-26

    Deerfield Imaging Recalls IMRIS ORT 100 Tables Due to Roll Drift

    Deerfield Imaging is recalling 27 IMRIS ORT 100 tables because they may drift in the roll position during use, posing a risk of patient injury.

    Product
    IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0618-2019·2018-12-26

    bioMerieux Recalls VITEK 2 Streptococcus Susceptibility Cards Due to False Results

    bioMerieux is recalling VITEK 2 Streptococcus Susceptibility Cards because they may produce false resistant results for specific Streptococcus strains.

    Product
    VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog # 410028, VITEK 2 AST-ST01 Catalog # 420915, VITEK 2 AST-ST02 Catalog # 421040, VITEK 2 AST-ST03 The VITEK 2 Streptococcus Susceptibility Card is intended for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0643-2019·2018-12-26

    Theragenics Brachytherapy Applicator Needles Recalled for Unsealed Pouches

    Theragenics is recalling Brachytherapy Applicator Needles because some pouches were not sealed, potentially compromising sterility.

    Product
    Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stylus with plastic handle, a plastic needle hub, a protective needle sleeve and the hollow steel needle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0750-2019·2018-12-26

    Moonstruck Chocolate Recalls Salty Nutty Toffee Bar for Undeclared Soy

    Moonstruck Chocolate Company is recalling 323 bars of ALMA Salty Nutty Toffee Bar because the product contains undeclared soy lecithin.

    Product
    The Salty Nutty Toffee Bar, brand ALMA, net weight 1.85 oz. UPC on individual bar: 8 58533 00602 8 UPC on master case 0 108585 330060 2 The label is read in parts: "***INGREDIENTS: Salty Nutty Toffee Bar *** Dark Chocolate (cocoa solids, cocoa butter, sugar, sunflower…
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0650-2019·2018-12-26

    Ortho-Clinical VITROS 5600 Recall for Software Stability Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to a software anomaly that may incorrectly extend reagent stability time.

    Product
    VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Product Slides, VITROS Chemistry Products MicroTip Reagents and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0614-2019·2018-12-26

    Philips Xper Flex Cardio Physiomonitoring System Recalled for Display Errors

    Philips is recalling 651 Xper Flex Cardio Physiomonitoring Systems because software defects may cause inaccurate waveform displays, frozen oxygen saturation values, or non-updating blood pressure readings.

    Product
    Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0616-2019·2018-12-26

    Siemens Dimension Vista 500 Recalled for Sample Contamination Risk

    Siemens is recalling Dimension Vista 500 instruments due to a software issue that may cause sample contamination if tests are manually cancelled during aliquoting.

    Product
    Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide