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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8226–8250 of 40007

  • ModerateFDA (Devices)·Z-0811-2024·2024-01-31

    MRI Liquid Cooling Cabinet may have incorrect electrical shock warning label

    Some Philips Intera 1.5T MRI systems have an incorrect warning label on the Liquid Cooling Cabinet that fails to properly warn service personnel of electrical shock hazards.

    Product
    Intera 1.5T, Model No. 781195
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0807-2024·2024-01-31

    MRI system warning label defect presents electrical shock risk to service personnel

    Achieva 1.5T MR systems have incorrect warning labels on the Liquid Cooling Cabinet, missing the high voltage warning symbol. This presents a potential electrical shock risk for service personnel.

    Product
    Achieva 1.5T, Model No. 781178, 781196, 781296
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0809-2024·2024-01-31

    Philips MRI system recalled for incorrect electrical warning label

    Philips Achieva 3.0T MRI systems have an incorrect electrical warning label on the liquid cooling cabinet, missing the high voltage symbol and proper yellow background. This presents a risk of electrical shock to service personnel.

    Product
    Achieva 3.0T, Model No. 781177
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0620-2024·2024-01-24

    Surgical Convenience Kit Recalled Due to Defective Component

    ROi CPS LLC is recalling 345 units of regard Operative LAP surgical convenience kits distributed in Louisiana because they were manufactured with a component that was subsequently recalled by Nurse Assist.

    Product
    regard Operative LAP, Item Number 800943001; surgical convenience kit
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0637-2024·2024-01-24

    Breathing Circuit Kits Recalled Due to Assembly Error Affecting Pressure

    Percussionaire Corporation is recalling High Frequency Transport Phasitron Breathing Circuit Kits due to assembly errors that can affect pressure output. The defect could impact respiratory support to patients using this device.

    Product
    High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
    Category
    Medical Device
    Distribution
    21 states
  • SevereFDA (Devices)·Z-0693-2024·2024-01-24

    Percussionaire Distal Phasitron respiratory device with reservoir bag assembly defect recalled

    Percussionaire Corporation recalled 195 Distal Phasitron devices after finding the breathing circuit reservoir bag may be assembled at the wrong attachment point, potentially affecting therapy delivery.

    Product
    Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0709-2024·2024-01-24

    Express Chest Drains Recalled for Infection Risk from Recalled Syringes

    Maquet Cardiovascular is recalling Express chest drains pre-packaged with recalled sterile water syringes. If not kept upright, patients may be exposed to infectious material, risking infection, abscess, sepsis, and death.

    Product
    Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0710-2024·2024-01-24

    FDA Recalls Express Chest Drain Blood Recovery Units Over Infection Risk

    Maquet Cardiovascular is recalling Express chest drain units with defective sterile water syringes. If not kept upright, patients risk exposure to infectious material that may cause infection, abscess, sepsis, or death.

    Product
    Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0762-2024·2024-01-24

    Maquet Orchide OR Light Systems recalled due to fall risk

    Getinge USA is recalling Maquet Orchide OR Light Systems due to a potential for light fixtures to fall in the operating room. No injuries have been reported.

    Product
    Maquet Orchide OR Light Systems, Model Numbers and Catalog Numbers OHDII FHD QL VP01 - ARD568803935, OHDII FHD QL AIR03 U - ARD568803952, OHDII FHD QL AIR03 E - ARD568803967, OHDII FHD QL AIR04 E/U - ARD568803968, OHDII FHD QL+ VP01 - ARD569204944, OHDII AIR03 QL FHD E - ARD56880
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0764-2024·2024-01-24

    Maquet Axcel Operating Room Light Systems Recalled for Fall Hazard

    The FDA is recalling Maquet Axcel and Axcel+ operating room light systems due to a potential for the light system to fall. The recall affects 236,793 units distributed nationwide and globally.

    Product
    Maquet Axcel / Axcel + OR Light Systems, Model Numbers and Catalog Numbers AXL 5001 - ARD567501961C, AXL 5001S - ARD567505961C, AXL 5002 - ARD567501962C, AXL 5002S - ARD567505962C, AXL 5501 - ARD567501960A, AXL 5501 - ARD567501960C, AXL 5501S - ARD567505960C, AXL+5001 DF - ARD567
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0731-2024·2024-01-24

    Philips Patient Information Center iX: Push Notifications May Fail to Send

    Philips Patient Information Center iX devices may fail to send push notifications under certain conditions, potentially delaying detection of patient condition changes. A total of 814 units have been recalled worldwide.

    Product
    (1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PIC iX Hardware, Model No. 866424
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0725-2024·2024-01-24

    Philips Spectral CT 7500 Recalled for Multiple Software Issues Affecting Functionality

    Philips is recalling 197 Spectral CT 7500 computed tomography systems due to multiple software issues affecting device functionality. The devices were distributed nationwide and internationally.

    Product
    Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0743-2024·2024-01-24

    High Pressure Rotator Infusion Device Recalled Due to Seal Defect

    Smiths Medical is recalling 31,685 HIGH PRESSURE ROTATOR infusion devices with a manufacturing defect that may cause an inadequate seal. The defect could lead to medication leaks and under-infusion.

    Product
    HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0756-2024·2024-01-24

    Cardinal Health Suction Canister Liners may lose suction due to misalignment

    Cardinal Health Medi-Vac suction canister liners in specific lots may lose suction on low settings due to misalignment of the liner with the outer canister. Stop using affected units and contact the manufacturer for replacements.

    Product
    Cardinal Health Suction Canister Liner, MEDI-VAC CRD 1000 mL Suction Canister Liner Kit with 6 mm 1.8 m Tube, REF 65651-517
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0760-2024·2024-01-24

    Maquet Rolite OR Light Systems Recall Due to Fall Risk

    Getinge USA is recalling 236,793 Maquet Rolite operating room light systems due to a potential for the light fixture to fall. No injuries have been reported.

    Product
    Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50SF - ARDPWT309001A, ROL PWDII50SF - ARDPWT309002A, ROL PWDII50SF - ARDPWT309009A, ROL PWDII50SF - ARDPWT309010A, ROL PWDII70SF - ARDPWT309007A, ROL PWDII70SF - ARDPWT309008A, ROL PWDII70SF - ARDPWT309015
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0716-2024·2024-01-24

    Olympus Laser Fiber Stripper Recall Due to Sterilization Validation Gap

    Olympus recalls fiber stripper models sold before 2023 lacking validated sterilization instructions, creating a contamination risk when used on sterile medical fibers.

    Product
    Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0748-2024·2024-01-24

    SOLTIVE SuperPulsed Laser Fibers Recalled for Potential Fiber Breakage During Surgery

    Olympus is recalling 82,200 units of SOLTIVE SuperPulsed Laser Fibers due to instruction inconsistencies that could cause fiber breakage during use, potentially resulting in burns or foreign material in the patient.

    Product
    SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0771-2024·2024-01-24

    Maquet Operating Room Light Systems Recalled Due to Fall Hazard

    Getinge Usa Sales Inc is recalling 236,793 Maquet operating room light systems nationwide due to a potential for the light system to fall, posing a safety risk to surgical patients and staff.

    Product
    Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems. No Model Numbers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0759-2024·2024-01-24

    Surgical Light Systems Recalled Due to Fall Hazard Risk

    Maquet Lucea operating room light systems are being recalled due to a potential for the light to fall in the operating room. No injuries have been reported.

    Product
    Maquet Lucea - Lucea10/40, Lucea50/100 OR Light Systems, Model Numbers and Catalog Numbers LCA 10 - ARD2LCA00040C, LCA 10 - ARDLCA109000C, LCA 10 - ARDLCA109002C, LCA 10 - ARDLCA109006C, LCA 10 - ARDLCA209008A, LCA 10 - ARDLCA209008C, LCA 10 - ARDLCA209009A, LCA 10 - ARDLCA209009
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0758-2024·2024-01-24

    Maquet Volista OR Light Systems Recalled for Fall Hazard

    Getinge is recalling Maquet Volista OR light systems that may fall during use in operating rooms. Approximately 236,793 units are affected nationwide and globally.

    Product
    Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System, Model Numbers and Catalog Numbers ROL B FOR VLT400SF STP - ARDROL309001A, ROL B FOR VLT400SF STP - ARDROL309001C, ROL B FOR VLT600SF STP - ARDROL309003A, ROL B FOR VLT600SF STP - ARDROL309003C, RO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0729-2024·2024-01-24

    Ultrasound examination tables recalled for backrest platform stress fractures

    Oakworks recalled 20 Ultrasound EA and G3 examination tables due to backrest platform stress fractures that prevent proper operation in inclined positions. Affected units are identified by serial number.

    Product
    Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echocardiography and Multi-Specialty with Electric Access Back Supports [left & right}
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0728-2024·2024-01-24

    Ultrasound Examination Table Recall Due to Backrest Platform Stress Fracture

    Oakworks Inc is recalling Ultrasound EA examination tables because the backrest platform can develop stress fractures, making the table inoperable in inclined positions. Approximately 104 units distributed nationwide are affected.

    Product
    Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography -An Ultrasound examination table
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0742-2024·2024-01-24

    Medex 700PSI Stopcock with Rotator Recalled Due to Seal Defect

    Smiths Medical is recalling Medex 700PSI stopcocks with rotators due to a manufacturing defect affecting the O-ring seal. The defect may cause medication leakage and under-infusion during patient treatment.

    Product
    Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0727-2024·2024-01-24

    Ultrasound examination table recalled due to backrest platform stress fracture

    Oakworks Inc is recalling 212 Ultrasound EA G2 examination tables nationwide due to stress fractures in the backrest platform that make the equipment non-operational in an inclined position.

    Product
    Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultrasound examination table
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0757-2024·2024-01-24

    Maquet PowerLEDII Operating Room Light System Recalled for Fall Risk

    Getinge Usa Sales Inc is recalling Maquet PowerLEDII OR light systems due to a potential for the light to fall in the operating room. No injuries have been reported.

    Product
    Maquet PowerLEDII OR Light System, Model Names and Catalog Numbers PWDII77SF - ARDPWT629100A, PWDII555DF - ARDPWT629101A, PWDII555SF - ARDPWT629102A, PWDII755DF - ARDPWT629103A, PWDII755SF - ARDPWT629104A, PWDII775DF - ARDPWT629105A, PWDII775SF - ARDPWT629106A, PWDII50DF - ARDPWT
    Category
    Medical Device
    Distribution
    Distributed nationwide