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.

24176–24200 of 50442

  • HighFDA (Devices)·Z-0736-2020·2020-01-01

    RayStation Radiation Therapy Software Recalled for Beam Editing Bug

    RaySearch Laboratories is recalling RayStation software versions 4.0 through 9.0 because a bug may reset beam settings, requiring dose recalculation.

    Product
    RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0 - Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0733-2020·2020-01-01

    Medtronic Lamicel Cervical Dilators Recalled for Sterilization Defect

    Medtronic Xomed is recalling Lamicel 20PK 3MM INTL Cervical Dilators because the sterilization dose did not meet the required Sterility Assurance Level.

    Product
    Lamicel 20PK 3MM INTL Cervical dilator
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0719-2020·2020-01-01

    3M Recalls Durapore Advanced Surgical Tape Due to Bond Failure Risk

    3M is recalling Durapore Advanced Surgical Tape because long-term exposure to high moisture may cause bond failure and fiber fraying, posing a risk of accidental ingestion or aspiration.

    Product
    3M Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1590-3, 1591-0, 1591-1, 1591-2, 1591-3, 1590S-1, 1590S-2, 1590B-118, 1590B-136
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0459-2020·2020-01-01

    Northern Fisheries Recalls Frozen Yellowfin Tuna Loins Due to Histamine Levels

    Northern Fisheries Ltd. is recalling 200 cases of frozen yellowfin tuna loins because they may contain increased levels of histamine, posing a risk of scombrotoxin fish poisoning.

    Product
    Frozen Yellowfin Tuna Loins, 5-8 lbs, Keep Frozen, Imported/Distributed: Mical Seafood Inc., 10400 Griffin Rd, Suite #209, Cooper City, Florida 33328
    Category
    Food
    Distribution
    5 states
  • HighNHTSA·19V924000·2019-12-27

    MCI Recalls 2018-2020 Coaches Due to Tag Axle Alignment Risk

    Motor Coach Industries is recalling 2018-2020 D4500 and D4505 coaches because tag axle clamps may slip, causing misalignment and increasing crash risk.

    Product
    MCI — MCI D4500, D4505
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0687-2020·2019-12-25

    Southwest Technologies Recalls Mold-Contaminated Elasto-Gel Wound Dressings

    Southwest Technologies Inc is recalling Elasto-Gel Absorbent Wound Dressings due to potential mold contamination. The affected sterile dressings were distributed to nine states.

    Product
    Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-0339-2020·2019-12-25

    Gourmet Bay Haddock with Seafood Stuffing Recalled for Listeria Risk

    Slade Gorton & Company is recalling Gourmet Bay Haddock with Seafood Stuffing because the stuffing may be contaminated with Listeria monocytogenes.

    Product
    GOURMET BAY Haddock with Seafood Stuffing; 6oz; SELL BY 05/26/21; LOT# 100457657; KEEP FROZEN; Cooking Instructions: Oven: Preheat oven to 400 degrees F. Place fish on a lined non-stick baking sheet. Bake for 15-20 minutes or until internal temperature reaches 165 degrees F.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0353-2020·2019-12-25

    Whole Foods Recalls Wedge Charred Corn Salad Due to Listeria Risk

    Whole Foods Market is recalling Wedge Charred Corn Salad served on the salad bar due to possible contamination with Listeria monocytogenes.

    Product
    Wedge Charred Corn Salad served on the salad bar
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0679-2020·2019-12-25

    Roche Homocysteine Test Recalled for Calibration Failures and Quality Control Issues

    Roche Diagnostics is recalling 82 units of Homocysteine tests due to calibration failures and quality control recovery issues on cobas c 701 and 702 modules.

    Product
    Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems Catalog Number: 06542921190 - - Product Usage: The assay can assist in the diagnosis of patients suspected of having…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0384-2020·2019-12-25

    Whole Foods Recalls Salmon Dinner with Thai Curry for Listeria Risk

    Whole Foods Market is recalling Salmon Dinner with Thai Curry for 2 due to possible contamination with Listeria monocytogenes.

    Product
    Salmon Dinner with Thai Curry for 2 Packaged in the store UPC 20451500000
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0114-2020·2019-12-25

    GE Healthcare Recalls Aestiva MRI Systems Due to Cybersecurity Vulnerability

    GE Healthcare is recalling 502 Aestiva MRI systems worldwide due to a cybersecurity vulnerability that could allow malicious actors to send fraudulent flow sensor correction parameters.

    Product
    Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e) 1006-9310-000-305077 f) 1006-9310-000-015243 g) 1006-9310-000-017602 h) 1006-9310-000-103785 I) 1006-9310-000-025109 j) 1006-9310-000-009650 k) 1006-9310-000-015224 l)…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0695-2020·2019-12-25

    Siemens Artis zee X-Ray System Recalled for Collision Sensor Defect

    Siemens is recalling three Artis zee Interventional Fluoroscopic X-Ray Systems because a collision sensor defect may block tabletop movement, potentially delaying or interrupting procedures.

    Product
    Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0351-2020·2019-12-25

    Whole Foods Recalls Salad Bar Item for Listeria Risk

    Whole Foods Market is recalling Trend Alert Caulilini with Vadouvan Curry from salad bars due to possible Listeria monocytogenes contamination.

    Product
    Trend Alert Caulilini with Vadouvan Curry served on the salad bar
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0712-2020·2019-12-25

    Angiodynamics Recalls 60 Micro-PSD HDR Radiation Therapy Sensors

    Angiodynamics, Inc. is recalling 60 Micro-PSD HDR sensors because they may provide readings outside the expected accuracy range.

    Product
    MICRO-PSD HDR, Catalog Number: PSD-HB5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0710-2020·2019-12-25

    Angiodynamics Recalls OARtrac PLUS Clinical Detector Units Due to Accuracy Issues

    Angiodynamics, Inc. is recalling four OARtrac PLUS Clinical Detector Units because they may produce readings outside the expected accuracy range.

    Product
    OARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0707-2020·2019-12-25

    Medtronic Percutaneous Pin Adapter Recall for Potential Rotation

    Medtronic is recalling 1,297 percutaneous pin adapters because they may rotate after surgical placement and fail to return to their original position.

    Product
    Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following kits: Upgrade Set Percutaneous Pin, REF 9735502 (GTIN 00643169529533) and REF 9735502-G02 (GTIN 00763000208462); Medtronic Adapter…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0347-2020·2019-12-25

    Stern Produce Recalls Baby Broccoli Due to Bacterial Contamination Risk

    Stern Produce Company Inc. is recalling one lot of Queen Victoria Sweet Baby Broccoli because it may be contaminated with bacteria from dripping ice water.

    Product
    Queen Victoria Sweet Baby Broccoli from Ippolito International, packed in ice in half bushel boxes, 18 count bunches/case, pack date of Nov 07 [2019], twist tie label on each bunch. Packaged by Ippolito International, Salinas, CA 93901 (see photos of labels on pgs. 3-4 of Att…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0680-2020·2019-12-25

    VisuMax Software Recall for Incorrect Corneal Cut Type During Suction Loss

    Carl Zeiss Meditec is recalling VisuMax software version 2.10.13 because a defect may cause a cap cut instead of a flap cut if suction is lost during treatment.

    Product
    VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser System for Refractive Correction. Catalog Number 0000000-1345-518 Product Usage: The VisuMax Femtosecond Laser is a precision…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0338-2020·2019-12-25

    Truly Good Foods South of the Border Nut Mix Recalled for Allergen Mislabeling

    Tropical Nut & Fruit Company is recalling 106 boxes of Truly Good Foods South of the Border nut mix because the label failed to declare soy and tree nuts (almonds).

    Product
    Truly Good Foods SOUTH OF THE BORDER nut mix NET CT/WT: 25lb box, CONTAINS: PEANUTS, MILK, AND WHEAT. Distributed by Truly Good Foods, Charlotte, N.C. 28273 UPC 0 94184 11019 8
    Category
    Food
    Distribution
    14 states
  • HighFDA (Food)·F-0386-2020·2019-12-25

    Whole Foods Recalls Grilled Caulilini for Possible Listeria Contamination

    Whole Foods Market is recalling Grilled Caulilini with Sweet Poppy Seed Sauce due to possible contamination with Listeria monocytogenes.

    Product
    Caulilini, Grilled with Sweet Poppy Seed Sauce sold in the chef's case and hot bar UPC 27268400000
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0340-2020·2019-12-25

    Gourmet Bay Salmon Roast Recalled for Listeria Contamination

    Slade Gorton & Company is recalling Gourmet Bay Salmon Roast with Crabmeat Stuffing because the stuffing may be contaminated with Listeria monocytogenes.

    Product
    GOURMET BAY Salmon Roast with Crabmeat Stuffing; SELL BY: 12/10/19; KEEP REFRIGERATED; Cooking Instructions: Remove product from package prior to cooking. Oven: Preheat oven to 375 degrees F. Bake for 30-35 minutes or internal temperature reaches 165 degrees F. Grill: Preheat…
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0689-2020·2019-12-25

    Teleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles

    Teleflex Medical is recalling 526,000 Arrow EZ-IO Intraosseous Vascular Access System kits because safety caps may dislodge, risking needle stick injuries and sterility compromise.

    Product
    Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, Product Code 9001P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal humerus, proximal tibia, and distal tibia of adult and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0706-2020·2019-12-25

    DeRoyal Warrior Recovery Knee Brace Recalled for Hinge Breakage Risk

    DeRoyal Industries is recalling Warrior Recovery Knee Braces because the hinge may break, causing the brace to come apart.

    Product
    DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP
    Category
    Medical Device
    Distribution
    Distributed nationwide