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.

19401–19425 of 50410

  • HighNHTSA·21V689000·2021-09-02

    Freightliner Cascadia trucks recalled for potential steering linkage separation

    Daimler Trucks North America is recalling 2019-2021 Freightliner Cascadia trucks due to improperly tightened drag link taper joints that could separate from the steering arm. Loss of steering control could result, increasing crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V681000·2021-09-02

    Indian Recalls 2020 Scout Bobber Sixty for Inoperable Brake Lights

    Indian Motorcycle is recalling 2020 Scout Bobber Sixty models because an ECU update may have disabled brake lights, increasing crash risk.

    Product
    INDIAN — INDIAN SCOUT BOBBER SIXTY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V687000·2021-09-02

    2021 Starcraft Telluride RV Propane Regulator Failure Fire Risk

    Starcraft is recalling certain 2021-2022 recreational vehicles with defective Winntec propane regulators that may fail, causing increased pressure and larger flames in gas appliances, raising fire risk.

    Product
    STARCRAFT RV FW — STARCRAFT RV FW, STARCRAFT RV TT TELLURIDE, SUPER LITE, AUTUMN RIDGE OUTFITTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V685000·2021-09-02

    Jayco Recreational Vehicles Recalled for Propane Regulator Fire Risk

    Jayco is recalling certain 2017-2022 recreational vehicles with Winntec propane regulators that may fail and increase propane pressure, raising the risk of fire in gas appliances.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER, JAYCO, JAYCO FIFTH WHEEL JAY FEATHER, EAGLE, redundant SEISMIC, TALON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2343-2021·2021-09-01

    Diagnostic MRI system recalled for pressure relief valve defect

    A Philips Ingenia MRI system has been recalled due to installation of a 42 psi pressure relief valve instead of the correct 3.75 psi valve, which may result in helium gas release and injury.

    Product
    Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0877-2021·2021-09-01

    Wegmans Sunflower Crunch Chopped Salad Kit recalled for undeclared milk and wheat allergens

    Wegmans Sunflower Crunch Chopped Salad Kit is being recalled because it contains undeclared milk and wheat allergens. Consumers with allergies to these ingredients should not consume the product.

    Product
    Wegmans Sunflower Crunch Chopped Salad Kit: Includes Green Cabbage, Green Leaf Lettuce, Sunflower Seeds, Red Cabbage, Carrot, Kale, Uncured Bacon, Green Onion with Wegmans Organic Coleslaw dressing. Washed and ready to eat. Salad and toppings: Net Wt 10.1 oz. (286 g) Dressing…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2344-2021·2021-09-01

    Philips Ingenia MRI System Equipped With Incorrect Pressure Relief Valve

    Philips Ingenia Elition X MRI systems contain an incorrectly installed pressure relief valve that may release helium gas and cause injury. The recall affects 6 U.S. units and 12 units distributed internationally.

    Product
    Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2354-2021·2021-09-01

    Accu-Chek Inform II glucose test strips may open during shipment

    Roche Diabetes Care is recalling Accu-Chek Inform II glucose test strips because vials may open during shipment, exposing strips to humidity and potentially causing inaccurate test results.

    Product
    Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2353-2021·2021-09-01

    Accu-Chek SmartView Test Strips May Open During Shipment

    Roche is recalling Accu-Chek SmartView Test Strip vials that may open during shipment. The vials can be exposed to humidity, damaging the strips and potentially causing inaccurate glucose readings.

    Product
    Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2351-2021·2021-09-01

    Accu-Chek Aviva Plus Test Strips Recalled for Potential Inaccurate Glucose Readings

    Roche Diabetes Care is recalling Accu-Chek Aviva Plus Test Strips because vials may open during shipment, exposing strips to humidity and causing inaccurate glucose readings that could lead to improper treatment decisions.

    Product
    Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2332-2021·2021-09-01

    Laboratory Data Management Software Recalled for Potential Patient Result Errors

    Beckman Coulter's Normand Remisol Advance Data Manager software versions 2.0 and 2.1 may add extra cells to patient requests, potentially causing erroneous patient results in clinical laboratories.

    Product
    Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0754-2021·2021-09-01

    Carvedilol 25 mg Tablets Recalled Due to Foreign Medication Contamination

    RemedyRepack Inc. is recalling Carvedilol 25 mg tablets after discovering that a 500-count source bottle contained two Paroxetine tablets (40 mg), which were then repackaged into 180-count bottles distributed to medical facilities in Virginia and Florida.

    Product
    Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ 08534, NDC 68382-0095-05, Repackaged by RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1826-01
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-2335-2021·2021-09-01

    AUGMENT Injectable Kit Recalled for Wrong Vial Tray in Package

    BioMimetic Therapeutics is recalling AUGMENT Injectable Kits (Model K30003010, Lot 1706343) because some packages contain the wrong vial tray. The recall affects 499 units distributed nationwide.

    Product
    AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2341-2021·2021-09-01

    MRI System Pressure Relief Valve Defect May Release Helium Gas

    Philips MRI systems contain an incorrectly rated pressure relief valve that may release helium gas and cause injury. The system was installed with a 42 psi valve instead of the required 3.75 psi valve.

    Product
    Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0755-2021·2021-09-01

    Pi yen chin Ophthalmic Redness Reliever Drops recalled due to sterility concerns

    Pi yen chin Ophthalmic Redness Reliever Drops are being recalled because they are actually manufactured as nasal drops and sterility cannot be assured. The product is labeled for ophthalmic use but does not meet the safety standards required for eye application.

    Product
    Pi yen chin Ophthalmic Redness Reliever Drops Made in China, Net Wt.: 10 ml (0.34 fl/oz) Exclusive U.S. Distributor: (Chinese writing)International Nature Nutraceuticals, Inc. New York, NY 10002 www.INNHERB.com. Konzon NDC 51367-008-10
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-2345-2021·2021-09-01

    MRI System Pressure Valve Installation Error Poses Helium Release Risk

    A wrong pressure relief valve was installed in Ingenia CX 3.0T MRI systems, which may release helium gas and cause injury to patients and staff.

    Product
    Ingenia CX 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0878-2021·2021-09-01

    Gordon Choice Deli Style Tuna Salad Recalled for Undeclared Wheat

    RMH Foods is recalling Gordon Choice Deli Style Tuna Salad (4 lb. containers) due to labeling errors that may expose consumers to undeclared wheat and tuna allergens. The product was distributed to Gordon Food Service retail stores and food service establishments across multiple states.

    Product
    Gordon Choice Deli Style Tuna Salad, Refrigerated, 4 Lb. retail unit, 2 4 Lb. retail units per wholesale case. Wholesale case labeled as Deli Style Tuna Salad The recalled product contains tuna salad, but it has two labels. The bottom container states Deli Style Chicken…
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-2340-2021·2021-09-01

    Gore Balloon Catheter Leakage Recall Affects 3,364 Units Worldwide

    W.L. Gore is recalling 3,364 units of its Molding & Occlusion Balloon Catheter due to leakage from the guidewire lumen and y-hub that can prevent proper inflation. No injuries have been reported.

    Product
    Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2355-2021·2021-09-01

    HARMONIC HD 1000i Surgical Shears Recalled for Potential Burn Risk

    Ethicon is recalling HARMONIC HD 1000i Shears because an internal component may crack and lodge behind the power button, causing continuous unintended activation and potential burns. Affected users should discontinue use immediately.

    Product
    HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2342-2021·2021-09-01

    Philips Ingenia MRI System recalled due to incorrect pressure relief valve

    Philips recalled 27 units of the Ingenia 1.5T Magnetic Resonance system with an incorrect pressure relief valve (42 psi instead of 3.75 psi) that could release helium gas and cause injury.

    Product
    Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2338-2021·2021-09-01

    MRI System Table Pads Missing Required Natural Rubber Allergen Label

    Table pads in Hitachi's ECHELON Oval MRI System contain natural rubber but lack required labeling on packaging and in user manuals. Federal regulations under 21 CFR 801.437 mandate disclosure of this material.

    Product
    ECHELON Oval MRI System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21193·2021-09-01

    TurboSke Kids Toddler Bike Helmets Recalled for Head Injury Risk

    SKE Outdoors is recalling about 860 TurboSke Kids Toddler Bike Helmets (size small) because they do not meet U.S. CPSC federal safety standards, posing a risk of head injury. No injuries have been reported.

    Product
    TurboSke Kids Toddler Bike Helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2347-2021·2021-09-01

    MRI System Pressure Relief Valve Installation Error May Release Helium Gas

    Philips MRI systems may have incorrect pressure relief valves installed, risking helium gas release and injury. Seven units contain 42 psi valves instead of required 3.75 psi valves.

    Product
    Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model…
    Category
    Medical Device
    Distribution
    Distributed nationwide