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.

13626–13650 of 53086

  • HighFDA (Food)·F-0725-2023·2023-04-19

    Nutri-Grain Bars in Meal Kits Recalled for Possible Metal Shavings

    E S Foods is recalling approximately 1 million Nutri-Grain Bar meal kits nationwide due to possible bronze metal shavings. Do not consume.

    Product
    61237 Nutri-Grain Bar, Strawberry BB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0729-2023·2023-04-19

    Mini Animal Graham meal kits recalled for bronze metal shavings

    E S Foods is recalling 61288 Mini Animal Graham Cinnamon SB meal kits nationwide because they may contain bronze metal shavings. Consumers should not eat affected products.

    Product
    61288 Mini Animal Graham Cinnamon SB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1359-2023·2023-04-19

    Titan Touch Pump Inflatable Prosthesis Recalled for Structural Defect Risk

    Coloplast Manufacturing is recalling Titan Touch Pump inflatable penile prostheses due to manufacturing defect causing decreased wall thickness that could lead to premature device failure.

    Product
    Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1362-2023·2023-04-19

    Inflatable Penile Prosthesis Pump Risk of Premature Failure

    Coloplast is recalling Titan Touch NB Infr Zero 18cm inflatable penile prostheses due to decreased pump wall thickness that may cause premature device failure after repeated use.

    Product
    Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1376-2023·2023-04-19

    Digital VIPR Oxygen Delivery Systems Recalled for Gauge Malfunction

    Western/Scott Fetzer is recalling 24,287 Digital VIPR oxygen delivery systems for a gauge malfunction that may display incorrect pressure readings. This could allow oxygen tanks to deplete without warning, potentially leaving users without oxygen flow.

    Product
    Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with E-size cylinder) MNDR-600, Western Oxytote DTE Digital VIPR (head only) MNDS-602, Western Oxytote DTE Digital VIPR System (with D-size…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1353-2023·2023-04-19

    PET/CT Imaging System Recall: Software Issue Prevents Image Reconstruction

    Shanghai United Imaging uMI 550 PET/CT imaging system is recalled due to a software defect that may prevent scatter correction during patient scanning, potentially blocking diagnostic PET image generation.

    Product
    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0730-2023·2023-04-19

    Meal kits with animal crackers recalled for possible metal shavings

    E S Foods is recalling 65550 5 Days Meal Kits nationwide because animal crackers may contain bronze metal shavings. Consumers should not consume the affected products.

    Product
    65550 5 Days Meal Kit
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·23V278000·2023-04-19

    2023 Heartland RV Recall: Incorrect Tire Information on Certification Labels

    Heartland Recreational Vehicles is recalling 2023 BIGHORN and BIG COUNTRY fifth wheels with incorrect tire information on federal certification labels, which could allow improper tire installation and increase crash risk.

    Product
    HEARTLAND — HEARTLAND BIG COUNTRY, BIGHORN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1377-2023·2023-04-19

    BioPlex 2200 Anti-CCP Reagent Pack Recalled for Reduced Diagnostic Specificity

    Bio-Rad is recalling BioPlex 2200 Anti-CCP Reagent Pack, Lot 301481, because the test's specificity is lower than claimed, which may increase false positive results. The diagnostic kit was distributed worldwide including the US, Canada, and several European countries.

    Product
    BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1370-2023·2023-04-19

    Inflatable Penile Prosthesis Recalled Due to Risk of Premature Pump Failure

    Coloplast is recalling Titan Touch Scro Zero Ang 20cm penile prostheses due to decreased wall thickness that could cause premature pump failure. Patients should contact their healthcare provider for guidance.

    Product
    Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1369-2023·2023-04-19

    Inflatable Penile Prosthesis Recalled for Premature Pump Failure Risk

    Coloplast is recalling Titan Touch Scro Zero Ang 16cm prostheses (Lot 8840677) due to decreased wall thickness that may cause premature pump failure. Affected devices were distributed worldwide, including throughout the US.

    Product
    Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1355-2023·2023-04-19

    Medical X-ray Systems Recalled for Electrical Fire Hazard

    Philips CombiDiagnost R90 X-ray systems (Model Numbers 709030 and 709031) may experience electrical fire in the main cabinet if exposed to overvoltage or power surge.

    Product
    CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1372-2023·2023-04-19

    Titan Inflatable Penile Prosthesis Pump Failure Risk Recall

    Coloplast is recalling the Titan 0-Deg Infrapubic 20 Cm inflatable penile prosthesis due to reduced wall thickness in the pump that could cause premature failure. No injuries have been reported.

    Product
    Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1387-2023·2023-04-19

    Step Bladeless Trocars recalled for sterilization failure

    Covidien's Step Bladeless Trocars (Model S101010, Lot P2G0069) are being recalled due to a sterilization process failure that may have resulted in unsterile instruments. Use of affected units may lead to infection or vision loss in eye procedures.

    Product
    Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0727-2023·2023-04-19

    Animal Crackers in Meal Kits Recalled for Possible Metal Contamination

    E S Foods is recalling 1,044,918 meal kits containing animal crackers distributed nationwide due to potential bronze metal shaving contamination. No illnesses have been reported.

    Product
    61247 Pop-Tart Fudge BB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1368-2023·2023-04-19

    Inflatable Penile Prosthesis Recalled for Risk of Premature Pump Failure

    Coloplast is recalling Titan Touch inflatable penile prostheses with reduced pump wall thickness, which could cause premature failure during use. The defect affects 8 units distributed across the US and multiple European countries.

    Product
    Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1352-2023·2023-04-19

    Flex-Neck Catheter Repair Kit design test product inadvertently distributed to patients

    Merit Medical Systems inadvertently distributed 17 Flex-Neck Catheter External Repair Kits intended for design verification testing to customers in Maryland, Michigan, Ohio, and Texas.

    Product
    Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1365-2023·2023-04-19

    Inflatable Penile Prosthesis Recalled for Potential Pump Failure Risk

    Coloplast is recalling certain Titan NB Infra Zero Ang 16cm inflatable penile prostheses due to thinner-than-standard pump wall thickness that could lead to premature pump failure.

    Product
    Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0724-2023·2023-04-19

    Meal kits with animal crackers recalled for potential bronze metal shavings

    E S Foods is recalling 1,044,918 meal kits sold nationwide. The animal crackers in these kits may contain bronze metal shavings, which could cause injury if consumed.

    Product
    61152 Smart Choice Chocolate Chip Muffin TSMB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1356-2023·2023-04-19

    X-ray System Models 706100 and 706110 Electrical Fire Risk from Power Surge

    Philips ProxiDiagnost R90 X-ray systems may experience electrical fires if exposed to overvoltage or power surges. The recalled systems affect 243 units distributed nationwide and globally.

    Product
    ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0715-2023·2023-04-19

    Frozen Raspberries Recalled Due to High Levels of Mold

    Multiple frozen raspberry products from B.C. Frozen Foods (Nature's Promise Organic, Stater Bros., SB, and Sunny Select brands) are being recalled due to high levels of mold contamination.

    Product
    1. Nature's Promise Organic Raspberries 10oz; Stand up plastic pouch in corrugated box; Product of Chile; 8x12 oz bags per case; 2. Stater Bros. Red Raspberries 12oz; Stand up plastic pouch in corrugated box; Product of USA; 12x12 oz bags per case; 3. SB Raspberries 12 oz…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0714-2023·2023-04-19

    White Castle Chicken Sliders recalled for undeclared soy allergen in labeling

    White Castle is recalling Chicken Slider sandwiches distributed in vending machines across six states due to incorrect labeling that fails to declare soy lecithin as an ingredient.

    Product
    White Castle Chicken Slider Individual sandwiches packaged as two sandwiches - 16 packages per case Unit Size 5.68oz/161g
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1388-2023·2023-04-19

    Chromic Gut Absorbable Sutures Recalled for Sterilization Failure Risk

    Covidien, LP is recalling chromic gut absorbable sutures due to sterilization failure that may leave product unsterile, creating risk of infection or vision loss in eye surgery.

    Product
    Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIC GUT 4-0 75CM V20 (GG-121), CHROMIC GUT 3-0 75CM V20 X36 (GG-122), CHROMIC GUT 2-0 75CM V20 X36 (GG-123), CHROMIC GUT 2-0 75CM V26 (GG-127), CHROMIC GUT 4-0…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0718-2023·2023-04-19

    Cheese Cup Meal Kits Recalled Due to Metal Shavings in Animal Crackers

    E S Foods is recalling 61490 Cheese Cup with 2 Grains meal kits because the animal crackers may contain metal shavings. These products were distributed nationwide.

    Product
    61490 Cheese Cup with 2 Grains MB (meal box)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0706-2023·2023-04-19

    Impossible Chicken Nuggets Recalled Nationwide for Wood Contamination

    Impossible Foods is recalling 128,029 cases of Impossible Chicken Nuggets nationwide due to potential wood contamination. The products should not be consumed.

    Product
    Impossible Chicken Nuggets Made From Plants packaged in the following names and package sizes: 1. Wild Nuggies, Net Wt. 13.5oz (383g), UPC 8 16697-02039 5; 2. Chicken Nuggets, Net Wt. 32 oz (907g), UPC 8 16697-02042 5; 3. Chicken Nuggets, Net Wt. 13.5oz (383g), UPC 8…
    Category
    Food
    Distribution
    Distributed nationwide