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.

17601–17625 of 50403

  • HighFDA (Devices)·Z-0737-2022·2022-04-13

    Philips StentBoost Live imaging system acquisition malfunction recall

    Philips Healthcare is recalling the StentBoost Live R2.0 application due to a software configuration error. The imaging system fails to stop image acquisition automatically, continuing indefinitely while the pedal is pressed instead of stopping after 40 images.

    Product
    Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V235000·2022-04-12

    Tesla Model S Boombox function obscures pedestrian warning system sounds

    Tesla is recalling certain 2020-2022 Model S, X, Y and 2017-2022 Model 3 vehicles. The Boombox feature can obscure Pedestrian Warning System sounds while driving. A free software update will disable Boombox in Drive, Neutral, and Reverse modes.

    Product
    TESLA — TESLA MODEL X, MODEL 3, MODEL Y, MODEL S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V236000·2022-04-12

    Prevost Recalls 2018 X3-45 Buses Due to Frayed Seat Belt Wires

    Prevost is recalling 2018 X3-45 buses because frayed seat belt wires may prevent buckles from working properly, increasing injury risk in crashes.

    Product
    PREVOST — PREVOST X3-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V234000·2022-04-11

    Newmar RVs recalled for unsecured seat wiring fire risk

    Newmar is recalling multiple 2019–2022 RV models due to unsecured wiring beneath seats that can cause electrical short circuits and fire. Owners should contact their dealer for free inspection and repair.

    Product
    NEWMAR — NEWMAR CANYON STAR, BAY STAR SPORT, BAY STAR, VENTANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22C001000·2022-04-08

    CYBEX Sirona M Child Seat Recall for Foam Choking Hazard

    Columbus Trading-Partners USA is recalling CYBEX Sirona M child seats because loose foam pieces from the headrest pad may pose a choking hazard to children.

    Product
    CHILD SEAT:MATERIAL/PADDING recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V232000·2022-04-08

    Mercedes-Benz 2018-2021 models recalled for rearview camera display failure

    Mercedes-Benz is recalling 126,443 vehicles from 2018-2021 because the rearview camera display may fail to show the rear view due to a software error, reducing visibility and increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GLB35, GLB 250, AMG CLA45, AMG CLA35
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V230000·2022-04-08

    Western Star trucks recalled for failing windshield wiper linkages

    Daimler Trucks North America is recalling certain 2020-2022 Western Star 49X and 2021 Western Star 47X vehicles because windshield wiper linkages may break, causing wipers to fail and reducing visibility.

    Product
    WESTERN STAR — WESTERN STAR 47X, 49X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V227000·2022-04-07

    Western Star commercial trucks recalled for detaching hood air intake covers

    Daimler Trucks North America is recalling certain 2020-2023 Western Star trucks equipped with side air intakes on the hood. The stainless steel cover may loosen and detach, creating a road hazard and increasing crash risk.

    Product
    WESTERN STAR — WESTERN STAR 57X, 49X, 47X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22738·2022-04-07

    biOrigins Sodium Hydroxide Products Recalled for Non-Child-Resistant Packaging

    CPSC recalls biOrigins sodium hydroxide products sold on Amazon from July 2020 through July 2021 due to non-child-resistant packaging and missing hazard label information. The product poses risk of chemical burns and skin/eye irritation to children.

    Product
    biOrigins Sodium Hydroxide Products
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0827-2022·2022-04-06

    Hand Pendant Malfunction in Proton Therapy Systems Poses Patient Injury Risk

    Mevion S250 and S250i Proton Therapy Systems hand pendants may malfunction, causing unintended motion of the therapy couch and nozzle. This poses a risk of patient injury if they contact moving equipment.

    Product
    Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0848-2022·2022-04-06

    Radiation therapy planning software subject to jaw positioning errors during optimization

    RayStation radiation therapy planning software (versions 6-11A) may unexpectedly change jaw positions during optimization after dose or target modifications. Users should verify treatment plans carefully before delivery.

    Product
    TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A. Build Numbers: 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.1.0.613, 11.0.0.951 or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0737-2022·2022-04-06

    Lansoprazole Capsules Recalled for Failed Dissolution in Stability Testing

    Dr. Reddy's Laboratories is recalling specific lots of Lansoprazole 15 mg delayed-release capsules nationwide because the capsules failed to dissolve properly during long-term stability testing, which could affect medication effectiveness.

    Product
    LANSOPRAZOLE — LANSOPRAZOLE (LANSOPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0734-2022·2022-04-06

    Testosterone Cypionate Injectable Vials Recalled for Lack of Sterility Assurance

    Drug Depot, Inc. is recalling 24 vials of Testosterone Cypionate 200 MG/ML Injectable nationwide due to lack of sterility assurance. The product was distributed throughout the USA and Puerto Rico.

    Product
    TESTOSTERONE CYPIONATE *GS* Oil 200 MG/ML Injectable, Packaged in a multi dose 10ML vial, Formula ID 76681, APS Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0850-2022·2022-04-06

    Medical software recall: RayStation radiation therapy dose calculation errors

    RayStation and RayPlan radiation therapy planning software may calculate incorrect radiation doses due to a source-to-skin distance calculation error. The FDA Class II recall affects 149 units distributed in the US.

    Product
    RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayStation 4.0 (4.0.0.14) to RayStation 5 Service Pack 2 (5.0.2.35), RayStation 5 Service Pack 3 (5.0.3.17), RayStation 6/RayPlan 2 (6.0.0.24), RayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0852-2022·2022-04-06

    Hanger-Bar 2P 45cm Recalled for Fall Hazard from Loosened Set Screw

    Human Care USA, Inc. is recalling the Hanger-Bar 2P 45cm because the set screw may loosen due to a manufacturing defect, creating a fall hazard.

    Product
    Hanger-Bar 2P 45cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0829-2022·2022-04-06

    Liko Universal Twinbar 670 QRH Patient Lift Accessory Recalled for Fall Risk

    Baxter Healthcare Corporation is recalling 1,399 Liko Universal Twinbar 670 QRH patient lift accessories due to an incorrect center bolt used during assembly. The defect could cause a patient to fall during use.

    Product
    Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko lifts, model numbers 3156087 and P3156087.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0730-2022·2022-04-06

    Injectable testosterone-anastrozole mixture recalled for sterility assurance failure

    Drug Depot (APS Pharmacy) is recalling testosterone cypionate/anastrozole injectable oil due to lack of sterility assurance. The recall affects 846 vials distributed nationwide.

    Product
    TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 4 ML Formula ID 115387; b) (RM) 10 ML Formula ID 115125; APS Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0826-2022·2022-04-06

    Retinal Analysis Software with Potentially Unapproved AI Features Recalled

    Diagnos Inc is recalling CARA retinal analysis software version 4.7.2 because some AI-based features may lack appropriate FDA market approval. Users are advised to revert to a prior software version.

    Product
    CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0729-2022·2022-04-06

    Gonadorelin injectable recalled for lack of sterility assurance

    Drug Depot recalls 1,843 vials of Gonadorelin injectable nationwide due to lack of sterility assurance. Patients should consult their healthcare provider regarding previously dispensed doses.

    Product
    (CA) GONADORELIN (4ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID136345, APS Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0733-2022·2022-04-06

    Injectable Testosterone Recalled Due to Lack of Sterility Assurance

    Drug Depot's testosterone injection product was recalled nationwide for lack of sterility assurance. Affected consumers should discontinue use and consult their healthcare provider.

    Product
    TESTOSTERONE CYPIONATE/PROPIONATE *SES* Oil (10 ML) 160MG/20MG/ML Injectable, Packaged in a multi dose 10ml vial, Formula ID 115498, APS Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0854-2022·2022-04-06

    Illumina NextSeq 550Dx DNA Analyzer Recalled for Short Circuit Risk

    Illumina is recalling 674 NextSeq 550Dx DNA sequence analyzers worldwide. A short circuit may occur after reconnecting circuit components, causing the device to become inoperable.

    Product
    Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
    Category
    Medical Device
    Distribution
    31 states
  • HighNHTSA·22V223000·2022-04-06

    Arcimoto Motorcycles Charging System Disabled at Freezing Temperatures

    Arcimoto is recalling 2019-2022 FUV, Rapid Responder, Deliverator, and Roadster motorcycles. The charging system may disable at freezing temperatures, potentially causing unexpected stalls and increasing crash risk.

    Product
    ARCIMOTO — ARCIMOTO FUV, DELIVERATOR, RAPID RESPONDER, ROADSTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0836-2022·2022-04-06

    Revogene diagnostic device recalled for photomultiplier tube malfunction

    Meridian Bioscience is recalling Revogene diagnostic devices due to compromised photomultiplier tubes that may produce false-positive or indeterminate test results.

    Product
    Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog Number 610210 GenePOC branded Revogene: Catalog Number 130840
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0909-2022·2022-04-06

    Schwan's Spinach & Artichoke Dip recalled due to product mislabeling

    Fairmont Foods is recalling Schwan's Spinach & Artichoke Dip because cartons may contain Chicken & Broccoli instead, creating potential allergen risks.

    Product
    Schwan's Spinach & Artichoke Dip. Item Number 061353, UPC 10038-68192. Net Wt. 24 oz. (1 lb. 8 oz.) 680g. Contains: 2 Bowls. Keep Frozen. Cook Thoroughly. Spinach and Artichokes blended with cream cheese and sour cream with Parmesan, Mozzarella, and Romano Cheeses.…
    Category
    Food
    Distribution
    Distributed nationwide