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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7526–7550 of 13652

  • 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-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-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-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-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-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-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-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-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-0770-2024·2024-01-24

    Maquet Blueline Series OR Light Systems Recalled Due to Fall Risk

    Getinge Usa Sales Inc is recalling Maquet Blueline Series 30/80 operating room light systems that may fall in the operating room. No injuries have been reported.

    Product
    Maquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numbers BLUE 30 - ARD569015111A, BLUE 30 - ARD569015111C, BLUE 30 - ARD569015131C, BLUE 30 - ARD569025111C, BLUE 30 - ARD569025131C, BLUE 30 - ARD569035111C, BLUE 30 - ARD569035131C, BLUE 30 - ARD569045111C,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-0721-2024·2024-01-24

    Curaplex Cricothyrotomy Field Kit Recalled for Incompatible Tube Holder

    Sarnova HC recalls 15 Curaplex Cricothyrotomy Field Kits nationwide due to an incompatible endotracheal tube holder that prevents proper tube securement during cricothyrotomy procedures.

    Product
    Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Item Number 351631i-A. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0723-2024·2024-01-24

    Endoscopic Vessel Harvesting System Recalled Due to Polyimide Particulate Matter Risk

    Maquet Cardiovascular is recalling the Vasoview Hemopro Endoscopic Vessel Harvesting System (model VH-3000-W) because polyimide particulate matter may be present on the device and could be introduced into arterial conduits during bypass graft surgery.

    Product
    Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .
    Category
    Medical Device
    Distribution
    0 states
  • 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-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-0741-2024·2024-01-24

    FDA Recalls Medical Pressure Tubing With Defective O-Ring Seals

    Smiths Medical is recalling 31,685 units of pressure tubing with defective O-rings that may not seal properly during medication infusion, potentially causing medication leaks and underdosing. The defect affects specific lot numbers with worldwide distribution.

    Product
    6IN PRESSURE TUBING, List Number MX20617
    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-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-0763-2024·2024-01-24

    Maquet PowerLED and PowerLED300 Surgical Light Systems Fall Hazard Recall

    Getinge recalls 236,793 units of Maquet PowerLED and PowerLED300 operating room light systems due to a potential for the light to fall in the operating room.

    Product
    Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Catalog Numbers EPS MB1 - ARDINT059002A, EPS MB1 - ARDINT059002C, EPS MB1 TR - ARDINT059000A, EPS MB1 TR - ARDINT059000C, EPS MB3 - ARDINT059003A, EPS MB3 - ARDINT059003C, EPS MB3 TR - ARDINT059001A, EPS MB3
    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
  • ModerateFDA (Devices)·Z-0736-2024·2024-01-24

    BD PosiFlush Prefilled Saline Syringes Recalled for Incorrect Stopper

    Becton Dickinson is recalling 5,085,120 BD PosiFlush Prefilled Saline Syringes due to an incorrect stopper that increases injection force and may trigger pump alarms.

    Product
    PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill), Catalog Number 306547
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0737-2024·2024-01-24

    V. Mueller Bandage Scissors recalled for pink dye staining on handles

    Steris Corporation is recalling V. Mueller Universal Bandage Scissors (Model SU2014-001) due to an incorrect resin carrier in the handle cover. Pink dye residue may appear on scissors and sterilization pouches after processing.

    Product
    V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- Intended to cut through tape and bandages Model: SU2014-001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0703-2024·2024-01-17

    Diagnostic Test Kits for GI Panel May Return False Negatives Due to Manufacturing Issue

    BioFire FILMARRAY GI Panel diagnostic test kits may return false negative results due to a manufacturing event, potentially leading to missed diagnoses and inappropriate treatment. The affected kits were distributed to locations in 16 U.S. states.

    Product
    BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.
    Category
    Medical Device
    Distribution
    16 states