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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3901–3925 of 39987

  • ModerateFDA (Devices)·Z-1788-2025·2025-05-28

    Philips SmartPath to dStream 1.5T medical device alignment recall

    Philips is recalling certain SmartPath to dStream 1.5T medical imaging devices due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

    Product
    Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1804-2025·2025-05-28

    MR 5300 Medical Device Recall for Cross Reference Line Alignment Error

    Philips is recalling MR 5300 medical devices (Model Numbers 782110 and 782152) due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

    Product
    Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1790-2025·2025-05-28

    Philips SmartPath to dStream Medical Imaging Software Alignment Error

    Philips is recalling SmartPath to dStream for XR and 3.0T medical imaging software due to potential alignment errors in cross reference line functionality when reviewing images with the MobiView application.

    Product
    Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1798-2025·2025-05-28

    Ingenia Ambition S MRI devices recalled for alignment errors

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

    Product
    Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1802-2025·2025-05-28

    Philips Ingenia Elition S MRI System Alignment Error Recall

    Philips is recalling certain Ingenia Elition S 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 Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1803-2025·2025-05-28

    Philips Ingenia Elition X MRI System Alignment Error Recall

    Philips has recalled specific Ingenia Elition 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 Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1800-2025·2025-05-28

    Ingenia 3.0T CX MRI System Alignment Error in Cross Reference Line

    Philips is recalling the Ingenia 3.0T CX MRI system due to potential alignment errors in the cross reference line when using the MobiView application to review images. The alignment error could affect image accuracy during review.

    Product
    Product Name: Ingenia 3.0T CX; Model Number: 781271;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1796-2025·2025-05-28

    Philips Ingenia 1.5T S MRI System Alignment Error Recall

    Philips is recalling the Ingenia 1.5T S magnetic resonance imaging (MRI) system due to potential alignment errors in cross reference line functionality when reviewing images generated with the MobiView application.

    Product
    Product Name: Ingenia 1.5T S; Model Number: 781347;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1786-2025·2025-05-28

    Check-Flo Performer Introducer medical device recall for incorrect sheath sizing

    Cook Incorporated is recalling Check-Flo Performer Introducer devices (10.0Fr) because affected units may contain an incorrectly sized introducer sheath, which could compromise proper device function.

    Product
    Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1794-2025·2025-05-28

    Philips Evolution Upgrade 3.0T MRI Cross Reference Line Alignment Error

    Philips is recalling Evolution Upgrade 3.0T MRI systems (Models 782117 and 782143) due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

    Product
    Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1799-2025·2025-05-28

    Philips Ingenia 1.5T CX MRI System Alignment Error Potential

    Philips is recalling Ingenia 1.5T CX MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images with the MobiView application. This could affect image interpretation.

    Product
    Product Name: Ingenia 1.5T CX; Model Number: 781262;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1813-2025·2025-05-28

    HiResolution Bionic Ear System M Battery Charger Labeling Mismatch Recall

    Advanced Bionics, LLC is recalling six units of the HiResolution Bionic Ear System - M Battery Charger (Model CI-5607) due to incorrect product labeling that does not match the intended product.

    Product
    HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1806-2025·2025-05-28

    Smith & Nephew Lag/Compression Screw Kit Undersized Socket Defect

    Smith & Nephew is recalling a Lag/Compression Screw Kit (REF: 71642690) because some compression screws have undersized hexagon sockets that render them non-functional and require replacement.

    Product
    META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1797-2025·2025-05-28

    Ingenia 3.0T MRI Systems Recalled for Image Alignment Errors

    Philips is recalling certain Ingenia 3.0T MRI systems worldwide due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

    Product
    Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1795-2025·2025-05-28

    Ingenia 1.5T MRI Systems Recalled for Alignment Errors

    Philips is recalling Ingenia 1.5T MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images with the MobiView application.

    Product
    Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1750-2025·2025-05-21

    TufTex Over-the-Wire Embolectomy Catheter incomplete sterile barrier

    LeMaitre Vascular is recalling TufTex Over-the-Wire Embolectomy Catheters due to incomplete seals on some packages that compromise the sterile barrier. Affected units were distributed nationwide and internationally.

    Product
    TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1651-68, 1651-78, 1651-84, 1651-88, E1651-34, E1651-38, E1651-44, E1651-48, E1651-64, E1651-68, E1651-78, E1651-84, E1651-88, 1651-44J, 1651-48J, 1651-84J, 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1726-2025·2025-05-21

    Welch Allyn Life2000 Compressor recalled for cybersecurity vulnerability

    Baxter Healthcare Corporation is recalling Welch Allyn Life2000 Compressor units due to a cybersecurity vulnerability discovered during internal testing.

    Product
    Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1725-2025·2025-05-21

    Welch Allyn Life2000 Ventilation System Recalled for Cybersecurity Vulnerability

    Baxter Healthcare Corporation is recalling the Welch Allyn Life2000 Ventilation system due to a cybersecurity vulnerability discovered through internal testing. The recall affects 4,881 units distributed worldwide.

    Product
    Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT200007; 5) BT-20-0007; 6) BT200011; 7) BT-20-0011; 8) RMS010118CP.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1730-2025·2025-05-21

    MedicaLyte Liquid Bicarbonate Concentrate Recalled for Foreign Matter

    Nipro Renal Solutions USA is recalling MedicaLyte Liquid Bicarbonate Concentrate (models BC+201 and BC+100) due to the potential presence of visible foreign matter in the product.

    Product
    MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1727-2025·2025-05-21

    iGo2 DC Car Adapter Recall: Overheating and Housing Deformation Risk

    Medical Depot Inc. is recalling 89,532 units of the iGo2 DC Car Adapter used with iGo2 Portable Oxygen Concentrator Systems. The DC power supply housing may become excessively hot to the touch and deform, posing a burn and fire hazard.

    Product
    iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1763-2025·2025-05-21

    LifeShield Infusion Safety Software Recalled for Drug Library Defects

    ICU Medical is recalling LifeShield Drug Library Management software v2.1 and v2.2 due to defects that could allow over-delivery of medication to patients or unauthorized modification of drug parameters.

    Product
    LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1698-2025·2025-05-21

    AirLife Infant Heated Wire Circuit Adapter Disconnection Risk Recall

    Vyaire Medical is recalling the AirLife Infant Heated Wire Circuit (model AH265) because adapters may disconnect during setup or use, potentially interrupting ventilation to newborns. Disconnection can cause hypoxia, hypercapnia, and organ failure.

    Product
    Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH265 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit Kit Dual-limb, Dual-heat, high-flow circuit (>4 L/min) Contains AH165 Circuit, AH290 Chamber Compone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1697-2025·2025-05-21

    AirLife Infant Heated Wire Circuit Adapter Disconnection Risk

    Vyaire Medical is recalling the AirLife Infant Heated Wire Circuit (Model AH165) because adapters may disconnect during setup or use, interrupting ventilation to infants and potentially causing severe complications.

    Product
    Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit dual-limb, dual-heat, high-flow circuit (>4 L/min) Component: No. a conduit for respiratory gas bet
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1749-2025·2025-05-21

    Abbott Alinity m Resp-4-Plex AMP Kit Multiplex PCR Test Recall

    Abbott Molecular is recalling the Alinity m Resp-4-Plex AMP Kit (List Number 09N79-096) due to reports of increased reactive negative controls and false positive results in respiratory viral testing.

    Product
    Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A virus (flu A), influenza B virus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1751-2025·2025-05-21

    Pruitt Occlusion Catheter Recalled Due to Incomplete Sterile Barrier Seals

    LeMaitre Vascular is recalling Pruitt Occlusion Catheters (catalog numbers 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56) because some packages have incomplete sterile barrier seals, potentially compromising product sterility.

    Product
    Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
    Category
    Medical Device
    Distribution
    Distributed nationwide