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.

3926–3950 of 52939

  • HighFDA (Devices)·Z-2216-2025·2025-08-06

    SmartPath to dStream XR gradient coils may act as heat source

    SmartPath to dStream for XR and 3.0T systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 294 units affected.

    Product
    SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0350-2025·2025-08-06

    Fresh Chilean salmon fillets processed under insanitary conditions in Georgia

    Fresh Chilean Salmon Fillets sold in 50 lb boxes are being recalled because ready-to-eat fish was processed under insanitary conditions, as notified by the Georgia Department of Agriculture.

    Product
    Fresh Chilean Salmon Fillet, Net WT (variable weight) 50 lb brown corrugated carboard box (up to 6 fillets per box). Boxes contain ice for temperature control. Keep Refrigerated.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2175-2025·2025-08-06

    Inseego dongle kit flash drives carry outdated patient monitor software

    Inseego USB8 4G Dongle Kits for the Tempus Pro Monitor are being recalled because the kit's USB flash drive contains outdated software that could revert the monitor and reintroduce a previous issue. 55 units affected.

    Product
    Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an accessory to the Tempus Pro Monitor, REF: 00-1007-R, 00-1024-R, 00-1026-R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2224-2025·2025-08-06

    Strep Selective II Agar plates may carry Listeria monocytogenes contamination

    Strep Selective II Agar, product number R01859, is being recalled because the products may contain surface and subsurface contamination of Listeria monocytogenes. 371 units are affected.

    Product
    Strep Selective II Agar, Product Number R01859
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0356-2025·2025-08-06

    Reisman's jumbo chocolate chip cookies recalled over undeclared wheat

    Reisman's Jumbo Chocolate Chip Cookies 3 oz are being recalled because of undeclared wheat. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's Jumbo Chocolate Chip Cookies 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·H-0368-2025·2025-08-06

    Reisman's cinnamon danishes recalled over undeclared wheat and soy

    Reisman's Cinnamon Danishes 3 oz are being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's Cinnamon Danishes 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2233-2025·2025-08-06

    LVP blood administration sets have potential for external cassette leaks

    LVP Blood Products Administration Sets are being recalled because of the potential for external cassette leaks. 14,280 units are affected.

    Product
    LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0358-2025·2025-08-06

    Reisman's jumbo pink and white cookies recalled over undeclared wheat

    Reisman's Jumbo Pink & White Cookies 3 oz are being recalled because of undeclared wheat. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's Jumbo Pink & White Cookies 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2234-2025·2025-08-06

    LVP primary administration sets have potential for external cassette leaks

    LVP Primary Administration Sets, Single Outlet Low Sorbing, are being recalled because of the potential for external cassette leaks. 35,925 units are affected.

    Product
    LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2212-2025·2025-08-06

    Philips MRI Machine Intera 3.0T Quasar Dual Recalled for Fire Risk

    Philips is recalling its Intera 3.0T Quasar Dual MRI system due to a potential fire hazard from gradient coil failures. The recall affects one unit distributed worldwide.

    Product
    Intera 3.0T Quasar Dual Model Number (REF): 781150;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0545-2025·2025-08-06

    Bicillin L-A 2.4 million unit vials recalled after particulates found

    Bicillin L-A (penicillin G benzathine injectable suspension) 2,400,000 units per 4 mL is being recalled because of CGMP deviations, with particulates identified during visual inspection. 19,279 vials affected.

    Product
    BICILLIN L-A — BICILLIN L-A (PENICILLIN G BENZATHINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2189-2025·2025-08-06

    Philips Allura R8.2.x systems may temporarily lose x-ray imaging functionality

    Philips Allura R8.2.x systems are being recalled because of the potential for temporary loss of imaging (X-ray) functionality due to a software issue. 4,508 units are affected.

    Product
    Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allura Xper FD20/10, Model Number: 722029. 5. Allura Xper FD10 OR Table,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2202-2025·2025-08-06

    Philips Evolution Upgrade 1.5T gradient coils may act as a heat source

    Evolution Upgrade 1.5T MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 93 units are affected.

    Product
    Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0361-2025·2025-08-06

    Reisman's cappuccino bars recalled over undeclared wheat and soy

    Reisman's Cappuccino Bars 3 oz are being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's Cappuccino Bars 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2218-2025·2025-08-06

    Philips MR 7700 upgrade gradient coils may act as a heat source

    Upgrade to MR 7700 systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 26 units are affected.

    Product
    Upgrade to MR 7700 Model Number (REF): 782130;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0354-2025·2025-08-06

    Bunge European style butter blend recalled over undeclared milk allergen

    NH European Style Butter Blend from Bunge, 1 lb blocks, is being recalled because of undeclared milk. 64,800 pounds across 1,800 cases are affected.

    Product
    NH EUROPEAN STYLE BUTTER BLEND, BUNGE, NET WT 1 LB, MFD IN USA BY: Bunge Oils, Chesterfield, MO 63017, packed in white paperboard cases (36 blocks to a case) OW NH EURO BLEND SOLIDS 2015918
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·H-0370-2025·2025-08-06

    Reisman's chocolate wrap recalled over undeclared wheat and soy

    Reisman's Chocolate Wrap 3 oz is being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's Chocolate Wrap 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·H-0360-2025·2025-08-06

    Reisman's fudge bars recalled over undeclared wheat and soy

    Reisman's Fudge Bars 3 oz are being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's Fudge Bars 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2222-2025·2025-08-06

    Osteotec silicone finger implants may contain foreign material

    Osteotec Silicone Finger Implants in sizes 3, 4 and 5 are being recalled because there is the potential that the silicone implant may contain foreign material. 15,573 units are affected.

    Product
    Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5) Software Version: N/A Product Description: The Osteotec Silicone Finger Implant is a one-piece, sterile, flexible silicone elastomer implan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2213-2025·2025-08-06

    Philips MR 5300 gradient coils may act as a heat source

    MR 5300 systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 551 units are affected.

    Product
    MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0364-2025·2025-08-06

    Reisman's cinnamon croissants recalled over undeclared wheat and soy

    Reisman's Cinnamon Croissants 3 oz are being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's Cinnamon Croissants 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·H-0373-2025·2025-08-06

    Reisman's chocolate flaky wrap recalled over undeclared wheat and soy

    Reisman's Chocolate Flaky Wrap 3 oz is being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's Chocolate Flaky Wrap 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·H-0375-2025·2025-08-06

    Reisman's soft chip cookie two-packs recalled over undeclared wheat

    Reisman's 2/pk Soft Chip Cookie with fudge filling, 3 oz, is being recalled because of undeclared wheat. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's 2/pk Soft Chip Cookie (with fudge filling) 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2177-2025·2025-08-06

    HarmonyAIR dual flat panel monitor yokes may detach from spring arm

    Dual Flat Panel Monitor accessories for HarmonyAIR A-Series Surgical Lighting Systems are being recalled because the yoke assembly may detach from the spring arm. 167 units are affected.

    Product
    Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide