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-0726-2024·2024-01-24

    PRIMA TT Shoulder Implant Baseplates Recalled for Manufacturing Defect Risk

    PRIMA TT shoulder implant baseplates are being recalled by Limacorporate due to manufacturing defects in the baseplate peripheral holes that could cause the implant to loosen or the screw to move.

    Product
    PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM REGULAR/1975.14.800, BASEPLATE D.25MM FULL WEDGED 10-degrees/1975.14.510, BASEPLATE D.28MM FULL WEDGED 10-degrees/1975.14.810, BASEPLATE
    Category
    Medical Device
    Distribution
    6 states
  • 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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
  • 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-0714-2024·2024-01-17

    Ambu aView 2 Monitor recalled for fire and burn hazard from oversized mounting screws

    Ambu is recalling the aView 2 A Monitor due to fire and burn hazards if mounting screws longer than 16mm are used. Improper installation can penetrate the lithium-ion battery, causing fires, severe burns, and smoke inhalation.

    Product
    Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
    Category
    Medical Device
    Distribution
    Distributed nationwide