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.

18551–18575 of 50407

  • HighFDA (Food)·F-0260-2022·2021-12-08

    Shirley's Neutral Whoopie Pie Mix recalled for potential metal contamination

    Puratos Corporation is recalling Shirley's Neutral Whoopie Pie MB Bag 50# (Batch Number 10584012) due to potential metal contamination. Consumers should not use the product.

    Product
    Shirley's Neutral Whoopie Pie MB Bag 50#. Material #4107773
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-0325-2022·2021-12-08

    Hurricane RX Dilation Balloon Recalled Due to Pinhole Defect Causing Pressure Loss

    Boston Scientific is recalling certain lots of the Hurricane RX Dilation Balloon due to a pinhole defect that causes loss of pressure or prevents the balloon from gaining or maintaining pressure during use, potentially prolonging medical procedures.

    Product
    HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545940
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0258-2022·2021-12-08

    One Step Neutral/Vanilla Mousse Contaminated with Foreign Metal Material

    Puratos Corporation is recalling One Step Neutral/Vanilla Mousse (Batch 10672511) due to potential contamination with metal fragments. Affected domestic and international customers should not use the product.

    Product
    One Step Neutral/Vanilla Mousse Bag 25#. Material #4107486
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0240-2022·2021-12-08

    Polar Black Cherry Premium Seltzer recalled for unlabeled sulfites

    Keurig Dr Pepper is recalling Polar Black Cherry Premium Seltzer 12-packs due to unlabeled sulfites. The recall affects 7,849 cases distributed nationwide with product code date 12/16/2022.

    Product
    Polar Black Cherry Premium Seltzer 12 pack of 12oz cans UPC Cardboard Wrap Code: 7153700228, UPC Can Code: 7153700110
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0323-2022·2021-12-08

    Boston Scientific HURRICANE RX Dilation Balloon Pressure Loss Recalled

    Boston Scientific is recalling HURRICANE RX Dilation Balloons across the US due to pinhole defects that cause pressure loss during endoscopic procedures. The defect may prolong procedures and affect patient safety.

    Product
    HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545920
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0252-2022·2021-12-08

    Dulcerio Sponge Cake Mix Recalled for Possible Metal Contamination

    Puratos Corporation is recalling Dulcerio Sponge Cake Mix Bag 40# (Batch Number 10644901) due to possible contamination with metal foreign material. The product was distributed to customers in multiple U.S. states and internationally.

    Product
    Dulcerio Sponge Cake Mix Bag 40#. Material #4107381
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0250-2022·2021-12-08

    Puratos TK014 Choc Creamie Powder Blend Recalled for Metal Contamination

    Puratos Corporation is recalling TK014 Choc Creamie Powder Blend in 40 lb. bags due to potential metal contamination. The affected product was distributed domestically and internationally.

    Product
    TK014 Choc Creamie Powder Blend Bag 40 lb. Item number 4107774
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0251-2022·2021-12-08

    Dom. Creme Ck Bag 50# Recall Due to Metal Contamination

    Puratos Corporation is recalling Dom. Creme Ck Bag 50# (Batch Number 10584006) due to possible contamination with metal fragments. The product was distributed domestically and to select foreign locations.

    Product
    Dom. Creme Ck Bag 50#. Material # 10584006
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-0324-2022·2021-12-08

    Boston Scientific Hurricane RX Dilation Balloon Recalled for Pressure Loss Defect

    Boston Scientific is recalling the Hurricane RX Dilation Balloon nationwide due to a pinhole defect causing loss of pressure or failure to maintain pressure during endoscopic procedures used to treat biliary strictures.

    Product
    HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545930
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0329-2022·2021-12-08

    GE Centricity Medical Imaging Software May Display Incomplete Patient Studies

    GE Healthcare recalled versions of Centricity Universal Viewer Zero Footprint Client software due to a potential defect that could display incomplete patient imaging studies. No injuries have been reported.

    Product
    GE Centricity Universal Viewer Zero Footprint Client
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V948000·2021-12-08

    Carson Fun Runner Trailers Recalled for Potential Gas Leak Risk

    Carson is recalling 2018-2020 Fun Runner FC20 trailers because an overtightened bolt may damage the stove's o-ring, causing a gas leak that increases fire risk.

    Product
    CARSON — CARSON FUN RUNNER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0275-2022·2021-12-08

    Herbal Doctor Angelicae Sinensis Recalled for Elevated Lead and Cadmium

    Murray International Trading Co., Inc. is recalling "Herbal Doctor" brand Angelicae Sinensis herb packages due to elevated levels of lead and cadmium contamination. The product has been distributed to consumers across the eastern and central United States.

    Product
    "Herbal Doctor" brand Angelicae Sinensis, Natural Herb, Net Wt. 16 oz (454 g) packaged in a green plastic bag; and 12oz (340g) packaged in a clear plastic box
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-0224-2022·2021-12-08

    Spiced Irish Coffee Hint of Cocoa Recalled for Undeclared Milk Allergen

    Trail Toddy & Company LLC is recalling Spiced Irish Coffee Hint of Cocoa packets because milk is not declared on the label despite cream powder being present in the product. The product was distributed in Illinois, Montana, and Massachusetts.

    Product
    Spiced Irish Coffee Hint of Cocoa, each packet weighs 1.09 oz (31g), 30 packets per case. UPC 8 60003 91546 2. The label is read in parts: "***Ingredients: CANE SUGAR, *CREAM POWDER, *COFFEE, COCOA POWDER, MOLASSES, HONEY, VANILLA, SEA SALT, *CINNAMON, *CLOVE, *STAR ANISE…
    Category
    Food
    Distribution
    3 states
  • HighNHTSA·21V940000·2021-12-03

    Zero Motorcycles Recalls 2022 SR Models Due to Incorrect Rear Brake Pads

    Zero Motorcycles is recalling 2022 SR, SR/F, and SR/S motorcycles because incorrect rear brake pads were installed, which may not work as intended and increase crash risk.

    Product
    ZERO — ZERO SR, SR/F, SR/S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V938000·2021-12-02

    2022 Hyundai Tucson: Inoperative Headlights and Taillights from Software Defect

    Hyundai is recalling 2022 Tucson vehicles with incompatible ICU software that can disable headlights and taillights, reducing visibility and increasing crash risk. All affected vehicles have been repaired.

    Product
    HYUNDAI — HYUNDAI TUCSON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V939000·2021-12-02

    2021 Acura RDX Driveshaft Defect May Cause Loss of Drive Power

    Honda is recalling certain 2021 Acura RDX vehicles because the front driveshaft may have been improperly heat-treated, potentially causing driveshaft failure and sudden loss of drive power or vehicle rollaway.

    Product
    ACURA — ACURA, HONDA RDX, CR-V HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0289-2022·2021-12-01

    CT Scanner Software May Cause Workflow Delays and Patient Rescans

    Siemens SOMATOM Edge Plus CT scanners with syngo.CT VB20 software may experience workflow interruptions, potentially delaying diagnoses and requiring patient rescans. The issue affects 64 units nationwide.

    Product
    SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0276-2022·2021-12-01

    Diagnostic thromboplastin reagent recalled due to performance issues

    Instrumentation Laboratory is recalling HemosIL ReadiPlasTin diagnostic reagent kits due to performance issues including imprecision and out-of-range quality controls that could result in inaccurate test results.

    Product
    HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0293-2022·2021-12-01

    Medtronic Wireless Recharger for InterStim Micro May Become Unresponsive

    Medtronic's wireless recharger for the InterStim Micro implantable neurostimulator may become unresponsive if charging procedures from the user guide are not followed. Approximately 10,081 devices are affected nationwide.

    Product
    Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810) implantable neurostimulator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0292-2022·2021-12-01

    Medtronic Endurant IIs stent graft recalled due to spindle detachment risk

    Medtronic recalls 419 Endurant IIs stent grafts due to risk of spindle detachment from the hypotube during deployment.

    Product
    Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0282-2022·2021-12-01

    Medtronic Cardiac Device Software Affected by Data Processing Error

    Medtronic is recalling software used in certain cardiac implant devices due to a data processing error that may fail to collect episode data. Approximately 18,715 devices are affected worldwide.

    Product
    Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds): Cobalt XT VR: DVPA2D1, DVPA2D4; Cobalt VR…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0241-2022·2021-12-01

    Philips CombiDiagnost R90 X-ray systems missing required radiation warning labels

    Philips Healthcare is recalling CombiDiagnost R90 X-ray systems because some units lack required FDA radiation warning labels and X-ray certification statements. No injuries have been reported.

    Product
    CombiDiagnost R90 is multi-functional general R/F systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0239-2022·2021-12-01

    Medical imaging device missing required radiation safety labels

    Philips Healthcare is recalling DigitalDiagnost C90 medical imaging devices because some units lack required radiation warning labels and X-ray certification statements. Affected customers should contact Philips to have the missing labels applied.

    Product
    DigitalDiagnost C90
    Category
    Medical Device
    Distribution
    Distributed nationwide