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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3476–3500 of 39987

  • ModerateFDA (Devices)·Z-2249-2025·2025-08-13

    GS endoscopy packs contain an inadvertently resterilized visualization system

    GS Endoscopy Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 816 units are affected.

    Product
    GS ENDOSCOPY PACK. Medical convenience kit.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2245-2025·2025-08-13

    daVinci urology kits contain an inadvertently resterilized visualization system

    DAVINCI UROLOGY medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 166 units are affected.

    Product
    DAVINCI UROLOGY. Medical convenience kit.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-2164-2025·2025-08-06

    Automated Impella Controllers may not detect a connected Impella pump

    The Automated Impella Controller, used with left heart support blood pumps, is being recalled because of a potential issue with the controller not detecting an Impella pump when it is connected. 11,031 units affected.

    Product
    Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2167-2025·2025-08-06

    Hamilton coaxial breathing circuits may have a crack in blue tubing

    Coaxial breathing circuit sets for HAMILTON-C1, T1 and MR1 ventilators are being recalled because the blue tubing that delivers fresh gas may be cracked, which can cause rebreathing of exhaled gases. 2,560 units affected.

    Product
    Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2161-2025·2025-08-06

    SafeStar 60A Plus breathing filters show a slow rising CO2 curve

    SafeStar 60A Plus bidirectional breathing system filters are being recalled following reports of a slow increase of the CO2 curve when the gas sample is taken from the filter's port. 374,700 units affected.

    Product
    SafeStar 60A Plus Filter. Bidirectionally breathing system filter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2159-2025·2025-08-06

    SafeStar 55 Plus breathing filters show a slow rising CO2 curve

    SafeStar 55 Plus bidirectional breathing system filters are being recalled following reports of a slow increase of the CO2 curve when the gas sample is taken from the filter's port. 9,885,139 units affected.

    Product
    SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2158-2025·2025-08-06

    SafeStar 90 Plus breathing filters show a slow rising CO2 curve

    SafeStar 90 Plus bidirectional breathing system filters are being recalled following reports of a slow increase of the CO2 curve when the gas sample is taken from the filter's gas sampling port. 669,838 units affected.

    Product
    SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2160-2025·2025-08-06

    HME TwinStar HEPA Plus filters show a slow rising CO2 curve

    HME TwinStar HEPA Plus bidirectional breathing system filters are being recalled following reports of a slow increase of the CO2 curve when the gas sample is taken from the filter's port. 1,019,782 units affected.

    Product
    HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2221-2025·2025-08-06

    Volcano Visions IVUS catheters can entangle with the guide wire

    Volcano Visions Digital IVUS Catheters are being recalled following reports of catheter and guide wire entanglement during radial-to-peripheral procedures, which may require surgical removal. 233,817 units affected.

    Product
    Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions for use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2214-2025·2025-08-06

    Philips MR 7700 gradient coils may act as a heat source

    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. 82 units are affected.

    Product
    MR 7700 Model Numbers (REF): (1) 782120, (2) 782153;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2225-2025·2025-08-06

    Blood EMB Levine plates may carry Listeria monocytogenes contamination

    Blood/EMB Levine plates, product number R02041, are being recalled because the products may contain surface and subsurface contamination of Listeria monocytogenes. 750 units are affected.

    Product
    Blood/EMB, Levine 100/PK, Product Number R02041
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Devices)·Z-2207-2025·2025-08-06

    Philips Ingenia 3.0T CX gradient coils may act as heat source

    Ingenia 3.0T CX 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. 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-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-2174-2025·2025-08-06

    HeartSine samaritan public access defibrillators may not deliver shocks properly

    HeartSine SAM 350P, 360P and 450P public access defibrillators are being recalled because a component manufacturing issue means the device may not function properly to deliver shocks. 190,516 units affected.

    Product
    HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2232-2025·2025-08-06

    LVP dual-inlet administration sets have potential for external cassette leaks

    LVP Primary Administration Sets, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site, are being recalled because of the potential for external cassette leaks. 19,225 units are affected.

    Product
    LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Devices)·Z-2188-2025·2025-08-06

    LIFEPEARL microspheres are smaller than specification, risking non-targeted embolization

    LIFEPEARL Drug Elutable Microspheres are being recalled because their actual average diameter is smaller than specification, which may lead to non-targeted embolization. 1,451 units affected.

    Product
    LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400
    Category
    Medical Device
    Distribution
    0 states
  • 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 (Devices)·Z-2226-2025·2025-08-06

    Blood MacConkey biplates may carry Listeria monocytogenes surface contamination

    Blood/MacConkey Biplates, product number R02049, are being recalled because the products may contain surface and subsurface contamination of Listeria monocytogenes. 611 units are affected.

    Product
    Blood/MacConkey Biplate 100/PK, Product Number R02049
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2208-2025·2025-08-06

    Philips Ingenia Ambition S gradient coils may act as heat source

    Ingenia Ambition 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. 611 units are affected.

    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-2206-2025·2025-08-06

    Philips Ingenia 3.0T gradient coils may act as a heat source

    Ingenia 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. 1,467 units are affected.

    Product
    Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-2204-2025·2025-08-06

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

    Ingenia 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. 2,279 units are affected.

    Product
    Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
    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