The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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2651–2675 of 13380

  • HighFDA (Devices)·Z-2178-2025·2025-08-06

    Steris Surgical Lighting Monitor Yoke Assembly May Detach

    Steris is recalling DFPM monitor accessories for HarmonyAIR E-Series surgical lighting systems because the yoke assembly may partially detach from the spring arm. Although it would remain suspended by wiring, this could pose safety concerns during surgical procedures.

    Product
    Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2213-2025·2025-08-06

    Philips MR 5300 MRI Systems Gradient Coil Fire and Smoke Risk

    Philips is recalling certain MR 5300 magnetic resonance imaging systems due to potential gradient coil component failures that could generate heat, smoke, or fire. The recall affects 551 units distributed worldwide, including the United States.

    Product
    MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2172-2025·2025-08-06

    Dental Drill Stop Kit Recalled for Incorrect Components

    Implant Direct Sybron Manufacturing LLC recalls 45 Drill Stop Kits due to incorrect components. The kits are used in dental implant procedures and were distributed in 14 US states and Japan.

    Product
    The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounting/removal of the Drill Stops. The Drill Stop Kit includes the Release Bracket, which is used for mounting and removing Drill Stops
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2226-2025·2025-08-06

    Blood/MacConkey culture plates recalled for potential Listeria contamination

    Remel is recalling Blood/MacConkey Biplate culture media (611 units) distributed nationwide due to potential surface and subsurface contamination with Listeria monocytogenes.

    Product
    Blood/MacConkey Biplate 100/PK, Product Number R02049
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2210-2025·2025-08-06

    Philips Ingenia Elition S MRI Systems Recalled for Fire Hazard

    Philips is recalling 242 Ingenia Elition S MRI systems worldwide due to potential gradient coil component failures that could produce smoke and fire. Affected facilities should immediately stop using the systems.

    Product
    Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2214-2025·2025-08-06

    Philips MR 7700 Imaging Systems Recalled for Potential Fire Hazard

    Philips is recalling MR 7700 imaging systems due to potential component failures in the gradient coil that may produce smoke and fire. The recall affects 82 units distributed worldwide.

    Product
    MR 7700 Model Numbers (REF): (1) 782120, (2) 782153;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2196-2025·2025-08-06

    Iontophoresis Patch Therapy Device Recalled for Non-Absorbing Pads

    LTS Therapy Systems is recalling IontoPatch STAT transdermal patches because the nonwoven pads fail to absorb saline solution, preventing the device from functioning as intended.

    Product
    IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2195-2025·2025-08-06

    FDA Recalls Microbiologics LYFO-DISK M. Canis Lab Control Organisms

    Microbiologics Inc. is recalling LYFO-DISK M. Canis and KWIK-STIK quality control organisms (REF 894-76 lots 894-76-4 and 894-76-6) because they may fail to recover the target microorganism, affecting laboratory testing integrity. Products distributed worldwide.

    Product
    LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2199-2025·2025-08-06

    SwabFlush Prefilled Syringe with Faulty Disinfecting Cap Poses Infection Risk

    Defective SwabCaps on SwabFlush prefilled syringes may reduce disinfection of luer access valves, potentially causing patient infection. The recall affects 1,427,100 units distributed nationwide and internationally.

    Product
    SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2233-2025·2025-08-06

    LVP Blood Products Administration Set Recalled for Potential Cassette Leaks

    Fresenius Kabi USA recalled 14,280 units of its LVP Blood Products Administration Set due to potential external cassette leaks. The sets were distributed nationwide to healthcare facilities.

    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 (Devices)·Z-2211-2025·2025-08-06

    MRI Gradient Coil Component Failure Risk: Potential Fire and Smoke Hazard

    Philips Ingenia Elition X MRI systems may have gradient coil component failures that could generate heat, smoke, and fire. Affected units were distributed worldwide including the United States.

    Product
    Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2235-2025·2025-08-06

    LVP Primary Administration Sets recalled due to potential external cassette leaks

    Fresenius Kabi USA recalls 348,150 LVP Primary Administration Sets nationwide due to potential for external cassette leaks that may affect medication delivery.

    Product
    LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2190-2025·2025-08-06

    BostonSight Scleral Contact Lenses Recall Due to Manufacturing Defects

    Boston Foundation For Sight is recalling 441 units of BostonSight SCLERAL contact lenses manufactured with errors affecting lens height and edge fit parameters.

    Product
    BostonSight SCLERAL Lens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2223-2025·2025-08-06

    Blood Agar Culture Media Recalled Due to Listeria Contamination Risk

    Remel Inc is recalling Blood Agar 5% Sheep Blood culture media due to potential surface and subsurface contamination with Listeria monocytogenes. The recall affects 1552 units distributed nationwide.

    Product
    Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2177-2025·2025-08-06

    Surgical Lighting Accessory Yoke Assembly May Detach from Spring Arm

    Steris is recalling 167 DFPM yoke assembly units for HarmonyAIR A-Series Surgical Lighting Systems. The yoke assembly may detach from the spring arm and hang from internal wiring.

    Product
    Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2205-2025·2025-08-06

    Philips MRI Systems Recalled for Gradient Coil Fire and Smoke Hazard

    Philips North America is recalling 136 Ingenia MRI systems due to potential gradient coil failures that could generate heat and produce smoke or fire. The affected units have been distributed worldwide.

    Product
    Ingenia 1.5T S Model Number (REF): 781347;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2215-2025·2025-08-06

    MRI System Gradient Coil Component May Overheat and Produce Fire or Smoke

    Philips MRI systems with affected gradient coils may experience component failures that could produce smoke or fire. Fifteen units worldwide are affected.

    Product
    SmartPath to dStream for 3.0T Model Number (REF): 782145;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2206-2025·2025-08-06

    Philips Ingenia 3.0T MRI Systems Recalled for Potential Fire Risk

    Philips is recalling 1,467 Ingenia 3.0T MRI systems worldwide due to potential gradient coil component failures that could produce smoke or fire.

    Product
    Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2208-2025·2025-08-06

    Philips Ingenia Ambition S MRI Systems Gradient Coil Fire Risk

    Philips is recalling 611 Ingenia Ambition S MRI systems due to potential gradient coil component failures that could generate heat, smoke, or fire. The affected units were distributed worldwide.

    Product
    Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2220-2025·2025-08-06

    Celsior Cold Storage Solution recalled for potential sterility assurance failure

    INSTITUT GEORGES LOPEZ has recalled 1,532 units of Celsior Cold Storage Solution, a sterile solution used to preserve hearts for transplantation, due to potential microbiological contamination from manufacturing defects. The affected lots were distributed in France.

    Product
    Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In US Celsior is a class II medical device. Celsior is a clear to slightly yellow, sterile, non pyrogenic solution for hypothermic flushing
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2218-2025·2025-08-06

    Philips MR 7700 Upgrade Recalled for Fire and Smoke Hazard

    Philips is recalling the MR 7700 imaging system upgrade due to potential Gradient Coil component failures that could generate heat, smoke, and fire. The recall affects 26 units with worldwide distribution.

    Product
    Upgrade to MR 7700 Model Number (REF): 782130;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2207-2025·2025-08-06

    Philips Ingenia 3.0T CX MRI Systems Recalled—Potential Fire Hazard

    Philips North America is recalling Ingenia 3.0T CX MRI systems worldwide due to potential gradient coil failures that may produce smoke and fire. About 350 units are affected.

    Product
    Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2224-2025·2025-08-06

    Strep Selective II Agar Recalled for Listeria Contamination

    Remel, Inc. is recalling Strep Selective II Agar (371 units) due to potential surface and subsurface contamination with Listeria monocytogenes. Users should contact the manufacturer for instructions.

    Product
    Strep Selective II Agar, Product Number R01859
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2201-2025·2025-08-06

    Medical Device Recall: Philips MRI System Fire and Smoke Risk

    Philips is recalling Achieva XR MRI systems (Models 781153, 781253) due to potential fire and smoke hazard from gradient coil component failures. Approximately 40 units distributed worldwide.

    Product
    Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2217-2025·2025-08-06

    Philips MR System Gradient Coil Failure May Produce Fire or Smoke

    Philips is recalling certain SmartPath to Ingenia Elition X magnetic resonance imaging systems due to potential gradient coil component failures that could generate heat and produce smoke or fire. Approximately 33 units are affected worldwide.

    Product
    SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;
    Category
    Medical Device
    Distribution
    Distributed nationwide