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.

32526–32550 of 50502

  • HighFDA (Devices)·Z-1798-2017·2017-04-19

    Windstone Medical Setup Packs Recalled for Potential Sterility Compromise

    Windstone Medical Packaging is recalling 500 Setup Packs containing Medtronic Curity Eye Pads due to potential sterile packaging compromise.

    Product
    Setup Pack, part number AMS3112(A Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1764-2017·2017-04-19

    Roche Recalls Cobas 8100 Reformatter Modules Due to Rack Crash Risk

    Roche Diagnostics is voluntarily recalling 45 Cobas 8100 reformatter modules because a rack crash can cause sample spillage, posing a risk of exposure to infectious material.

    Product
    Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Food)·F-1927-2017·2017-04-19

    Dolcetta Dark Chocolate Hazelnut Bar Recalled for Undeclared Soy Lecithin

    Dolcetta Artisan Sweets is recalling 80 Dark Chocolate Hazelnut Bars distributed in Oregon and Washington due to undeclared soy lecithin.

    Product
    Dark Chocolate Hazelnut Bar is dark chocolate with milk chocolate and hazelnuts, 1.2 oz (33g), product wrapped in metal foil and then wrapped in paper box.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1943-2017·2017-04-19

    Dolcetta Rosemary Caramel Bar Recalled for Undeclared Soy and Milk

    Dolcetta Artisan Sweets is recalling 250 Rosemary Caramel Bars in Oregon and Washington due to undeclared soy lecithin.

    Product
    Rosemary Caramel Bar is dark chocolate with rosemary infused caramel, 1.2 oz (33g), product wrapped in metal foil and then wrapped in paper box. The label declared: '"***Rosemary Caramel Bar *** 60% dark chocolate, cane sugar, cream, glucose (wheat), butter, rosemary, sea…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1819-2017·2017-04-19

    Intuitive Surgical Recalls da Vinci Xi Suction Irrigator Instruments

    Intuitive Surgical is recalling 90 da Vinci Xi Suction Irrigator instruments due to unexpected arm motion with specific software.

    Product
    da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and SOFTWARE, EMBEDDED RLS, IS4000, A70_P6_B440; PN 610092-440. General and Plastic Surgery: The EndoWrist¿ Suction Irrigator is designed to be used in conjunction with an Intuitive Surgical da Vinci…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Food)·F-1881-2017·2017-04-19

    Companion Foods Recalls Braised Bean Curd for Wheat Mislabeling

    Companion Foods Corp. is recalling Braised Bean Curd (Mock Chicken) because wheat is not properly declared as a sub-ingredient in the ingredient list.

    Product
    BRAISED BEAN CURD (MOCK CHICKEN)10 oz. cans, 24 cans per case. Product of Taiwan UPC CODE: 0 76277 10419 2 Companion Foods Corp. Taipei, Taiwan
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1793-2017·2017-04-19

    Windstone Medical Minor Operation Kit Recall Due to Sterile Packaging Concerns

    Windstone Medical Packaging is recalling 700 Minor Operation Kits because the sterile packaging of the included Medtronic Curity Eye Pad may be compromised.

    Product
    Minor Operation Kit, part number AMS1530 Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1815-2017·2017-04-19

    RayStation Radiation Therapy Software Recalled for GPU Driver Error

    RaySearch Laboratories is recalling RayStation software due to a potential calculation error in non-standard Citrix environments.

    Product
    Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1930-2017·2017-04-19

    Dolcetta Artisan Sweets Recalls Dark Chocolate Pretzel Santa for Undeclared Soy

    Dolcetta Artisan Sweets is recalling 30 boxes of Dark Chocolate Pretzel Santa because the product contains undeclared soy lecithin.

    Product
    Dark Chocolate Pretzel Santa, net wt. 150 g (5.3 oz) The label declared "***Ingredients: 60% dark chocolate, 49% milk chocolate, pretzels, butter, white chocolate, sea salt *** Contains wheat and milk***".
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1884-2017·2017-04-19

    Companion Foods Recalls Szechuan Style Kung-Pao Sauce for Wheat Mislabeling

    Companion Foods Corp. is recalling Szechuan Style Kung-Pao Sauce because wheat is not properly declared in the ingredient list, posing a risk to individuals with wheat allergies.

    Product
    SZECHUAN STYLE KUNG-PAO SAUCE (HOT PAPAO LAJAN), 10 oz. cans, 24 cans per case. Product of Taiwan UPC CODE: 0 76277 10395 9 Companion Foods Corp. Taipei, Taiwan
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1795-2017·2017-04-19

    Windstone Medical Recalls Ortho Basic Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 12 Ortho Basic Packs because the sterile packaging of the included eye pads may be compromised.

    Product
    Ortho Basic Pack, part number AMS6459 Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·17V262000·2017-04-19

    Winnebago Recalls 2014-2017 Motorhomes Due to Electrical Interference

    Winnebago is recalling 2014-2017 View, VIA, ERA, and Itasca Navion motorhomes because a radio module may interfere with the electrical system, potentially causing engine shutdown or power loss.

    Product
    WINNEBAGO — WINNEBAGO, ITASCA VIA, VIEW, NAVION, ERA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1786-2017·2017-04-19

    Windstone Medical Recalls Custom Kits with Compromised Sterile Eye Pad Packaging

    Windstone Medical Packaging is recalling 164 custom kits containing Medtronic Curity Eye Pads due to potential sterile packaging compromise.

    Product
    Custom Tray, part numbers PSS1111 and PSS1111(A. Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1758-2017·2017-04-19

    ConMed Recalls Hyfrecator 2000 Accessory Packages with Non-Sterile Sheaths

    ConMed is recalling Hyfrecator 2000 accessory packages because they contained non-sterile handpiece sheaths labeled as sterile.

    Product
    Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons , 220 VOLTS AC, REF/Catalog Number 7-900-220, Rx Only, There is no problem with the Hyfrecator 2000 Electrosurgical Units…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1796-2017·2017-04-19

    Windstone Medical Packaging Recalls Plastic Packs with Compromised Sterile Eye Pads

    Windstone Medical Packaging is recalling 376 plastic kits containing Medtronic Curity Eye Pads because the sterile packaging may be compromised.

    Product
    Plastic Pack, part numbers AMS1028, AMS1028(A, and WAL1189. Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1938-2017·2017-04-19

    Dolcetta Artisan Sweets Recalls Milk Chocolate Almond Hearts for Undeclared Soy

    Dolcetta Artisan Sweets is recalling 30 boxes of Milk Chocolate Almond Hearts due to undeclared soy lecithin. The product was distributed in Oregon and Washington.

    Product
    Milk Chocolate Almond Heart contains solid milk chocolate with almonds, 110g (4 oz), the product is packaged in a clear plastic box.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1783-2017·2017-04-19

    Windstone Medical Packaging Recalls Cataract Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 4,065 cataract kits because the sterile packaging of the included eye pads may be compromised.

    Product
    Cataract Kit, part numbers CAT1467AM and CAT1538(B. Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1933-2017·2017-04-19

    Dolcetta Espresso Caramels Recalled for Undeclared Soy and Milk Allergens

    Dolcetta Artisan Sweets is recalling 98 boxes of Espresso Caramels sold in Oregon and Washington due to undeclared soy lecithin.

    Product
    Espresso Caramels are caramels flavored with expresso, 3.9 oz (110g), individually wrapped in cellophane and then wrapped in a paper box.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1770-2017·2017-04-19

    Siemens Combi Dockable Neurosurgery Table Recalled for Height Drop Risk

    Siemens Medical Solutions is recalling three Combi Dockable Neurosurgery tables for MRI systems due to a potential manufacturing error that could cause a sudden drop in table height.

    Product
    Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1919-2017·2017-04-19

    Kowalski's Markets Protein Powerhouse Recalled for Metal Contamination

    J & J Distributing Company is recalling Kowalski's Markets Protein Powerhouse because shred carrots used as an ingredient were contaminated with metal pieces.

    Product
    Kowalski's Markets, Protein Powerhouse, UPC 6-10014-14692-4, 8 oz in plastic container.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1929-2017·2017-04-19

    Dolcetta Artisan Sweets Recalls Dark Chocolate Pretzel Bars for Allergens

    Dolcetta Artisan Sweets is recalling Dark Chocolate Pretzel Bars because they contain undeclared soy lecithin and wheat.

    Product
    Dark Chocolate Pretzel Bar contains dark chocolate and pretzels, 1.2 oz (33g), product wrapped in metal foil and then wrapped in paper box.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1946-2017·2017-04-19

    Dolcetta Artisan Sweets Recalls Salty Caramels Due to Undeclared Soy and Milk

    Dolcetta Artisan Sweets is recalling 80 boxes of Salty Caramels distributed in Oregon and Washington due to undeclared soy lecithin.

    Product
    Salty Caramels are chewy caramels that are salty, 3.9 oz (110g), individually wrapped in cellophane and then wrapped in a paper box. The label declared "***Salty Caramels *** Cane sugar, cream, butter, golden syrup, sea salt, bourbon vanilla bean***".
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1816-2017·2017-04-19

    Hill-Rom TotalCare Bed Systems Recalled for Alarm Malfunction

    Hill-Rom is recalling TotalCare Bed Systems because the exit alarm may fail if armed for over 72 hours without triggering.

    Product
    TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Patient Position Monitoring and Scale Upgrade Kits, Model Numbers P1947A and P1948A).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1779-2017·2017-04-19

    GE Healthcare Recalls Vivid Ultrasound Systems Due to Patient Selection Error

    GE Healthcare is recalling Vivid E95, E90, and E80 ultrasound systems because slow search times can cause operators to select the wrong patient, potentially leading to misdiagnosis.

    Product
    Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1924-2017·2017-04-19

    Dolcetta Artisan Sweets Recalls Assorted Bonbons for Undeclared Soy Lecithin

    Dolcetta Artisan Sweets is recalling Assorted Bonbons because they contain undeclared soy lecithin. The product was distributed in Oregon and Washington.

    Product
    Assorted Bonbons are molded chocolates with ganache fillings in assorted flavors, No package weight. Product packaged in a black plastic tray and then tray is placed in a paper box with clear plastic lid.
    Category
    Food
    Distribution
    2 states