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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7501–7525 of 13652

  • 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-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-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
  • HighFDA (Devices)·Z-0751-2024·2024-01-24

    Medical Device Calibration Serums Recalled Due to Instructional Transcription Errors

    Randox Laboratories has recalled multiple calibration serum products due to transcription errors in the Instructions for Use, which contain incorrect target values for several analytes.

    Product
    Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)
    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-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-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-0754-2024·2024-01-24

    Suction Canister Liner Recalled for Loss of Suction on Low Settings

    Cardinal Health Suction Canister Liners may lose suction on low or intermittent settings due to liner misalignment. Approximately 3.5 million units are affected across the US, Canada, Australia, and New Zealand.

    Product
    CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0739-2024·2024-01-24

    Medex LOGICAL CATH LAB KIT Recalled for Oversized O-Ring Defect

    Smiths Medical is recalling the Medex LOGICAL CATH LAB KIT due to a manufacturing defect where the O-ring inner diameter may be oversized, affecting seal integrity and potentially leading to medication under-infusion.

    Product
    Medex LOGICAL CATH LAB KIT, List Number M20754
    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-0769-2024·2024-01-24

    Maquet G8 Operating Room Light Systems Recalled for Fall Risk

    Getinge USA is recalling Maquet G8 and G8E operating room light systems that may fall during use. Approximately 236,793 units have been distributed nationwide and globally.

    Product
    Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C, G8G8FS DF - ARD568121131C
    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-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-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-0642-2024·2024-01-24

    ExcelsiusGPS surgical navigation system calibration error may cause device misplacement

    Globus Medical is recalling the ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit due to a calibration error that may cause inaccurate navigation and device misplacement during surgery. Nine units are distributed across select US states and internationally.

    Product
    ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0747-2024·2024-01-24

    Smiths Medical Injection Line Rotating Adapters Recalled for Seal Defect

    Smiths Medical is recalling specific injection line rotating adapters due to a manufacturing defect causing oversized O-rings that may lead to inadequate seal integrity and medication under-infusion.

    Product
    48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
    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-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-0750-2024·2024-01-24

    GammaPod Radiation Treatment Planning System Software Error Allows Wrong Imaging Structures

    Xcision Medical Systems recalled 4 GammaPod Treatment Planning Systems due to a software error that allows incorrect radiation structures from previous CT scans to be imported and selected, potentially affecting treatment planning accuracy.

    Product
    GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 Intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.
    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-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-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-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-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-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