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.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

7526–7550 of 13666

  • HighFDA (Devices)·Z-0761-2024·2024-01-24

    Maquet Operating Room Light Systems Recalled Due to Fall Risk

    Getinge USA Sales Inc is recalling Maquet Equipment OR Light Systems due to a potential risk that the light systems could fall in the operating room. Approximately 236,793 units have been distributed.

    Product
    Maquet Equipment OR Light Systems, Model Numbers and Catalog Numbers BRAINLAB CAMERA - ARDEQT269000A, BRAINLAB CAMERA - ARDEQT269000C, BRAINLAB CAMERA - ARDEQT269001A, BRAINLAB CAMERA - ARDEQT269001C, BRAINLAB CAMERA - ARDEQT269004A, BRAINLAB CAMERA - ARDEQT269004C, BRAINLAB CAME
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0768-2024·2024-01-24

    Maquet Hanaulux HLX2000 Operating Room Lights Recalled Due to Fall Hazard

    Getinge Usa Sales Inc is recalling Maquet Hanaulux HLX2000 OR Light Systems because the light fixture may fall from its mounting in the operating room. Nearly 237,000 units are affected.

    Product
    Maquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 - ARD567703001C, 4001 S/DF - ARD567211211C, 4001 SAD/DF - ARD567221211C, 4001 SAD/DF - ARD567221241C, 4001 SAD/SF - ARD567221141C, 4001 SAI/DF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0766-2024·2024-01-24

    Maquet XTen OR Light Systems Recalled for Potential Fall Hazard

    The FDA is recalling multiple Maquet XTen OR Light System models because they may unexpectedly fall in the operating room. The recall affects 236,793 units distributed nationwide and globally.

    Product
    Maquet XTen OR Light Systems, Model Numbers and Catalog Numbers 3001 HMD14 - ARD567732001C, X TEN DUO - ARD568221510C, X TEN DUO - ARD568221561C, X10AXL DF - ARD568211010C, X10AXL SF - ARD568231010C, X10AXL+ DF - ARD568211710C, X10AXLDUO - ARD568211000C, X10DF - ARD568211110C, X1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0717-2024·2024-01-24

    Medical Fiber Cleaver System Recalled for Contamination Risk

    Olympus Corporation recalled 236 fiber cleaver units distributed non-sterile but labeled as reusable and autoclavable. Without validated sterilization instructions, use on sterile fiber poses contamination risk.

    Product
    Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC
    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
  • HighFDA (Devices)·Z-0735-2024·2024-01-24

    Intraocular Lens Cylinder Axis Marks Out of Specification

    Johnson & Johnson is recalling TECNIS Toric II intraocular lenses distributed in Japan. The cylinder axis marks do not meet product specifications and could affect vision correction.

    Product
    TECNIS Toric II OptiBlue IOL Models ZCW
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0740-2024·2024-01-24

    Medical Device Stopcock Recalled Due to O-Ring Seal Defect

    Smiths Medical Asd Inc is recalling approximately 31,685 Stopcock Left Rotator devices due to oversized O-rings that may compromise seal integrity. The defect may cause medication leaks, potentially resulting in under-infusion during treatment.

    Product
    1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL
    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-0718-2024·2024-01-24

    SOLTIVE SuperPulsed Laser Fibers May Have Breached Sterile Pouch Seals

    Olympus Corporation recalls 179 SOLTIVE SuperPulsed Laser Fibers due to potentially breached sterile pouch seals that could cause procedure delays or patient infections if not detected before use.

    Product
    SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0752-2024·2024-01-24

    Medical Diagnostic Calibration Serum Recalled for Positive Measurement Bias

    Randox Laboratories is recalling Calibration Serum Level 3 (CAL2351) distributed in the US and Puerto Rico because it exhibits a positive bias in CK Total measurements on RX Series instruments, potentially affecting test accuracy by up to 13%.

    Product
    Calibration Serum Level 3 CAL2351
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0720-2024·2024-01-24

    Field Cricothyrotomy Kit Recalled for Incompatible Endotracheal Tube Holder

    Sarnova HC is recalling the Curaplex Field Cric Kit due to an incompatible endotracheal tube holder that prevents practitioners from securing the tube during cricothyrotomy procedures. The recall affects 1,063 kits distributed nationwide.

    Product
    Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0744-2024·2024-01-24

    High Pressure Rotator with O-Ring Seal Defect Recalled Worldwide

    Smiths Medical is recalling High Pressure Rotators due to a manufacturing defect affecting O-ring seals. An oversized inner diameter may cause inadequate seal integrity, risking medication under-infusion.

    Product
    HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP
    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-0755-2024·2024-01-24

    Suction Canister Liners Recalled for Potential Loss of Suction Function

    Cardinal Health suction canister liners may lose suction on low settings due to liner misalignment. Approximately 203,244 units distributed to the US, Canada, Australia, and New Zealand.

    Product
    Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Canister Liner Kit with 5 mm 1.8 m Tube, REF 65651-516
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0732-2024·2024-01-24

    CareEvent Medical Device Push Notifications May Fail to Send

    The CareEvent patient monitoring device may fail to send push notifications, potentially delaying detection of patient condition changes.

    Product
    (1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0730-2024·2024-01-24

    Ultrasound Examination Table Recalled for Backrest Stress Fracture

    Oakworks Inc is recalling 28 Ultrasound EA examination tables due to backrest platform stress fractures that prevent operation in an inclined position.

    Product
    Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography -An Ultrasound examination table
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0753-2024·2024-01-24

    Calibration Serum with Mis-assigned Alkaline Phosphatase Target

    Randox Calibration Serum Level 3 has an incorrect Alkaline Phosphatase target value (approximately 10% off) affecting clinical chemistry testing on RX Series instruments.

    Product
    Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0724-2024·2024-01-24

    Endoscopic Vessel Harvesting System Recalled Due to Polyimide Particulate Matter Risk

    Maquet Cardiovascular is recalling 38,094 units of the Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500, due to polyimide particulate matter contamination that may be introduced into the arterial conduit during coronary artery bypass or peripheral bypass surgery.

    Product
    Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0719-2024·2024-01-24

    Incisive CT systems with ECG cable risk of signal loss

    Philips Incisive CT systems with specific ECG cable may experience signal loss due to connector weakness, potentially delaying diagnosis.

    Product
    Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0765-2024·2024-01-24

    Maquet Hanaulux HLX3000 Operating Room Light Systems Recall for Fall Hazard

    Getinge Usa Sales Inc is recalling approximately 236,793 Maquet Hanaulux HLX3000 operating room light systems nationwide and globally due to a potential for the light system to fall in the operating room.

    Product
    Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H3 BC - HM567811111C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0767-2024·2024-01-24

    Maquet Prismalix OR Light Systems recalled due to fall hazard

    Getinge has recalled 236,793 Maquet Prismalix operating room light systems because the systems could potentially fall. The recall affects units distributed nationwide in the U.S. and globally.

    Product
    Maquet Prismalix OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 - ARD567703001C, 4001 S/DF - ARD567211211C, 4001 SAD/DF - ARD567221211C, 4001 SAD/DF - ARD567221241C, 4001 SAD/SF - ARD567221141C, 4001 SAI/DF - ARD56
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0733-2024·2024-01-24

    VACUETTE Blood Collection Tubes Missing Critical Anticoagulant Additive

    VACUETTE blood collection tubes are missing an anticoagulant additive, causing samples to clot and producing inaccurate or absent lab results. This can delay diagnosis or lead to inappropriate treatment.

    Product
    VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.
    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-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-0749-2024·2024-01-24

    Link Patella Glide Resection Guide recalled due to size mislabeling

    A surgical guide used in knee replacement is recalled due to mislabeling showing incorrect dimensions. This could result in improper bone resection and implant fit, potentially extending surgery time.

    Product
    Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. Product Code: 15-2530/05
    Category
    Medical Device
    Distribution
    Distributed nationwide