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.

4426–4450 of 52939

  • HighFDA (Devices)·Z-1789-2025·2025-05-28

    SmartPath to dStream 3.0T Medical Device Recall for Software Error

    Philips is recalling the SmartPath to dStream 3.0T medical device due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. This could affect image interpretation accuracy.

    Product
    Product Name: SmartPath to dStream for 3.0T; Model Number: 782145
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1801-2025·2025-05-28

    Philips Ingenia Ambition X MRI Systems Alignment Error in MobiView

    Philips is recalling certain Ingenia Ambition X MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

    Product
    Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1807-2025·2025-05-28

    TRUE 3D VIEWER SYSTEM displays medical images with incorrect orientation

    Echopixel's TRUE 3D VIEWER SYSTEM may display imaging data with incorrect orientation (left/right/superior/inferior/anterior/posterior), which could lead to inaccurate measurements during clinical use.

    Product
    TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care professionals HCPs and is intended to assist the clinician who is responsible for making all patient management decisions. The True 3D V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0820-2025·2025-05-28

    Verde Salsa Recalled for Potential Wood Particle Contamination

    Frobright Salsary, LLC is recalling Verde Salsa due to potential contamination with wood particles. The recall affects 12.5 oz containers distributed in Alaska, Idaho, Oregon, and Washington.

    Product
    Verde Salsa is refrigerated product, packaged in Polypropylene container, net wt. 12.5 oz, UPC 1 18738 03719. San Juan Salsa Co. Arlington, WA 98223, www.sanjuansalsa.com
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0810-2025·2025-05-28

    Zeke's Daddy's Granola Recalled for Undeclared Tree Nuts

    BBF Massachusetts LLC is recalling Zeke's Daddy's Granola because it contains undeclared almond and cashew, which pose a serious allergen risk to consumers with tree nut allergies.

    Product
    Zeke's Daddy's Granola; INGREDIENTS: Whole grain rolled oats, maple syrup, expeller pressed canola oil, coconut, brown sugar, molasses, cinnamon, salt, natural flavor; Contains coconut; Manufactured in a facility that uses peanuts, tree nuts, soy, wheat, sesame, and milk; 30 LBS;
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1805-2025·2025-05-28

    Philips MR 7700 Medical Device Alignment Error in MobiView Application

    Philips is recalling MR 7700 model medical devices due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

    Product
    Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1812-2025·2025-05-28

    PhenoMATRIX bacterial culture plate interpretation software recalled nationwide

    Copan WASP is recalling PhenoMATRIX, an AI-powered bacterial culture plate interpretation software, because it lacks required FDA premarket approval, creating potential risk of inaccurate colony counts and morphology data that could affect patient diagnosis.

    Product
    PhenoMATRIX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0806-2025·2025-05-28

    Yellowstone Brown Sugar Molasses Baked Beans Recall for Undeclared Soy

    Vietti Acquisitions, LLC is recalling Yellowstone Brown Sugar Molasses Baked Beans because the cans are mislabeled and actually contain Beef and BBQ Baked Beans with undeclared soy, a common allergen.

    Product
    Yellowstone Brown Sugar Molasses Baked Beans, NET WT. 15 OZ (425g), packaged in cans, packed 12 cans per case. UPC: 071846187071; Packaged by: Vietti Foods Inc. Nashville, TN 37203
    Category
    Food
    Distribution
    23 states
  • HighFDA (Devices)·Z-1787-2025·2025-05-28

    Check-Flo Performer Introducer Medical Device Recall Notice

    Cook Incorporated is recalling Check-Flo Performer Introducer devices because some units from affected lots may contain an incorrectly sized introducer sheath.

    Product
    Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0807-2025·2025-05-28

    Lactoferrin Apolactoferrin Vegetarian Capsules Recalled for Undeclared Milk

    My Life Inc is recalling Lactoferrin as Apolactoferrin 300 mg vegetarian capsules (UPC 8 50062 61315 7) because they contain undeclared milk allergen, which poses a risk to consumers with milk allergies.

    Product
    Lactoferrin as Apolactoferrin 60 vegetarian capsules, 300 mg per serving. UPC 8 50062 61315 7. Amazon ASIN #B0DNLMBHGG.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0815-2025·2025-05-28

    San Juan Salsa Medium Salsa recalled for potential wood particle contamination

    Frobright Salsary, LLC is recalling San Juan Salsa Medium Salsa (14 oz containers) due to potential contamination with wood particles. The product was distributed in Alaska, Idaho, Oregon, and Washington.

    Product
    Medium Salsa is refrigerated product, packaged in Polypropylene container, net wt. 14oz, UPC 1 18738 54633. San Juan Salsa Co. Arlington, WA 98223, www.sanjuansalsa.com
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0821-2025·2025-05-28

    San Juan Medium Salsa recalled due to potential wood particle contamination

    San Juan Medium Salsa 32 oz containers sold at Costco are being recalled due to potential contamination with wood particles. The affected product was distributed in Alaska, Idaho, Oregon, and Washington.

    Product
    Medium Salsa Costco item, is refrigerated product and packaged in Polypropylene container, net wt. 32 oz, UPC 1 18738 01016. San Juan Salsa Co. Arlington, WA 98223, www.sanjuansalsa.com
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0818-2025·2025-05-28

    Pineapple Mango Salsa recalled for potential wood particle contamination

    Frobright Salsary, LLC is recalling Pineapple Mango Salsa due to potential contamination with wood particles. The 13 oz containers were distributed in Alaska, Idaho, Oregon, and Washington.

    Product
    Pineapple Mango Salsa is refrigerated product, packaged in Polypropylene container, net wt. 13 oz, UPC 1 18738 63010. San Juan Salsa Co. WA 98223, www.sanjuansalsa.com
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1791-2025·2025-05-28

    SmartPath to Ingenia Elition X MRI Systems Alignment Error Recall

    Philips is recalling SmartPath to Ingenia Elition X MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. The alignment errors could affect image interpretation.

    Product
    Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1785-2025·2025-05-28

    True 3D Viewer Model EP-00003 Software Orientation Display Issue Recall

    Echopixel's True 3D Viewer (Model EP-00003) with certain software versions can display ultrasound image orientation incorrectly, potentially leading to misdiagnosis or incorrect surgical planning.

    Product
    True 3D Viewer, Model: EP-00003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V351000·2025-05-27

    Kia K5 parking lights can flicker due to a software error

    Kia is recalling certain 2025 K5 vehicles because a software error in the Power-net Domain Controller may cause the parking lights to flicker, failing FMVSS 108.

    Product
    KIA — KIA K5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V338000·2025-05-23

    Lincoln seat belt warning chime may sound for less than four seconds

    Ford is recalling certain 2020-2023 Lincoln Aviator and Corsair vehicles with Revel Audio, previously repaired under 22V-953, because the unbelted warning chime may sound for under four seconds.

    Product
    LINCOLN — LINCOLN AVIATOR, CORSAIR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V337000·2025-05-23

    Lincoln Nautilus displays can reboot leaving the driver a blank screen

    Ford is recalling certain 2024 Lincoln Nautilus vehicles because multimedia module software may cause the panoramic and centre displays to reboot, leaving a blank screen.

    Product
    LINCOLN — LINCOLN NAUTILUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V348000·2025-05-23

    Ford Recalls 2021 F-150 Trucks for Inoperative Reverse Lights

    Ford is recalling 2021 F-150 trucks with Onboard Scales because a previous software update may have disabled the reverse lights, increasing crash risk.

    Product
    FORD — FORD F-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V197000·2025-05-23

    Ford Recalls 2018-2020 Expedition and Navigator for Seat Belt Defect

    Ford is recalling 2018-2020 Expedition and Lincoln Navigator vehicles because seat belt pretensioners may lock, preventing belts from retracting or extending.

    Product
    LINCOLN — LINCOLN, FORD NAVIGATOR, EXPEDITION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V346000·2025-05-23

    Ford Recalls 2020 Expedition and Navigator for Software Error

    Ford is recalling 2020 Expedition and Navigator vehicles where previous repairs left pre-collision assist features inoperative due to a software error.

    Product
    FORD — FORD, LINCOLN EXPEDITION, NAVIGATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide