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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8201–8225 of 39844

  • 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-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-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-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-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-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-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-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-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-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-0745-2024·2024-01-24

    Braided Injection Line Recalled for Potential Medication Leaks

    Smiths Medical is recalling approximately 31,685 units of a braided injection line due to manufacturing defects in the O-ring seal. The defect may cause medication leaks that reduce drug delivery.

    Product
    20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR
    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-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-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-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-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-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-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-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-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-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-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