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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2401–2425 of 27346

  • HighFDA (Devices)·Z-2198-2025·2025-08-06

    CoSense sampling sets may carry residual carbon monoxide from insufficient aeration

    Precision Sampling Sets for the CoSense End-Tidal Carbon Monoxide Monitor are being recalled because residual carbon monoxide may remain in the cannula filter, which may raise ETCOc scores. 2,160 units affected.

    Product
    Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2210-2025·2025-08-06

    Philips Ingenia Elition S gradient coils may act as a heat source

    Ingenia Elition S 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. 242 units are affected.

    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-2209-2025·2025-08-06

    Philips Ingenia Ambition X gradient coils may act as heat source

    Ingenia Ambition X 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. 690 units are affected.

    Product
    Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2203-2025·2025-08-06

    Philips Evolution Upgrade 3.0T gradient coils may act as heat source

    Evolution Upgrade 3.0T 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. 50 units are affected.

    Product
    Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • HighFDA (Devices)·Z-2211-2025·2025-08-06

    Philips Ingenia Elition X gradient coils may act as heat source

    Ingenia Elition X 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. 632 units are affected.

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

    HarmonyAIR E-Series monitor yokes may detach from the spring arm

    Dual Flat Panel Monitor accessories for HarmonyAIR E-Series Surgical Lighting Systems are being recalled because the yoke assembly may detach from the spring arm. 59 units are affected.

    Product
    Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2215-2025·2025-08-06

    SmartPath to dStream 3.0T gradient coils may act as heat source

    SmartPath to dStream for 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. 15 units affected.

    Product
    SmartPath to dStream for 3.0T Model Number (REF): 782145;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2235-2025·2025-08-06

    LVP dual Y-site administration sets have potential for external cassette leaks

    LVP Primary Administration Sets, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site, are being recalled because of the potential for external cassette leaks. 348,150 units are affected.

    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-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 (Devices)·Z-2205-2025·2025-08-06

    Philips Ingenia 1.5T S gradient coils may act as heat source

    Ingenia 1.5T S 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. 136 units are affected.

    Product
    Ingenia 1.5T S Model Number (REF): 781347;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2223-2025·2025-08-06

    Blood agar plates may carry Listeria monocytogenes surface contamination

    Blood Agar with 5% Sheep Blood, product number R01202, is being recalled because the products may contain surface and subsurface contamination of Listeria monocytogenes. 1,552 units affected.

    Product
    Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Devices)·Z-2153-2025·2025-07-30

    Medline labor triage kits contain ChloraPrep applicators with open seals

    Medline LABOR TRIAGE KIT convenience kits are being recalled because they contain BD ChloraPrep Clear 1 mL Applicators that may exhibit an open seal, which may breach sterility. 960 units affected.

    Product
    Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2134-2025·2025-07-30

    Azurion 7 M20 C-arm gearbox mounting bolts may become loose

    The Azurion 7 M20 fluoroscopic x-ray system is being recalled because of the potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose. 78 units affected.

    Product
    Azurion 7 M20. Fluoroscopic X-Ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2170-2025·2025-07-30

    Stryker StrykeFlow suction irrigator may leak solution into the handpiece

    The Stryker StrykeFlow Disposable Suction/Irrigator is being recalled because irrigation solution may leak into the handpiece and battery pack, causing it to malfunction.

    Product
    Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2149-2025·2025-07-30

    Bodor i Series laser cutting machines fail federal laser safety standards

    Bodor i Series laser cutting machines are being recalled because they fail to meet certain applicable federal standards at 21 CFR 1040.10(f)(1) and (f)(2). 20 units are affected.

    Product
    Bodor's I series laser cutting machine.
    Category
    Other
    Distribution
    0 states
  • HighFDA (Devices)·Z-2137-2025·2025-07-30

    Endosee convenience kits label non-sterile iodine pouches as sterile

    Endosee System Convenience Kits with IV Tube are being recalled because they contain non-sterile iodine pouches while the peel away lid labels incorrectly identify them as sterile. 475 units affected.

    Product
    Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2136-2025·2025-07-30

    Endosee system convenience trays label non-sterile iodine pouches as sterile

    Endosee System Convenience Kits are being recalled because they contain non-sterile iodine pouches while the peel away lid labels incorrectly identify them as sterile. 991 units are affected.

    Product
    Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2162-2025·2025-07-30

    BD COR system software issue could produce possible false negative results

    BD COR System Software version 8.80 and above is being recalled because of a potential functionality issue supporting the Over labeling feature that could lead to possible false negative results. 7 systems affected.

    Product
    BD COR System Software. Model Number: 444829.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2168-2025·2025-07-30

    SmartSync Patient Connector limited the window to abort high voltage therapy

    The Medtronic CareLink SmartSync Patient Connector is being updated because in prior application versions the abort window during an induction test limited the user's ability to cancel high voltage therapy. 22,091 devices affected.

    Product
    Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2132-2025·2025-07-30

    Discovery MR750w gradient coils can produce acoustic noise above the limit

    GE HealthCare Discovery MR750w 3.0T MR systems are being recalled because gradient coils can produce acoustic levels exceeding the 99 dB limit set by IEC 60601-2-33 during scanning.

    Product
    Discovery MR750w 3.0T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2131-2025·2025-07-30

    SIGNA Architect AIR gradient coils can produce acoustic noise above limit

    GE HealthCare SIGNA Architect AIR MR systems are being recalled because gradient coils can produce acoustic levels exceeding the 99 dB limit set by IEC 60601-2-33 during scanning.

    Product
    SIGNA Architect AIR
    Category
    Medical Device
    Distribution
    Distributed nationwide