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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11526–11550 of 13802

  • HighFDA (Devices)·Z-1362-2022·2022-07-20

    Pressure Monitoring Sets with Excess Coating Pose Embolism Risk

    Cook Incorporated is recalling approximately 11,451 Pressure Monitoring Sets because excess coating material on the needle component may enter the bloodstream, potentially causing pulmonary embolism or ischemia.

    Product
    Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1374-2022·2022-07-20

    Ventana HE 600 Automated Slide Preparer Recalled for Potential Electrical Fire Risk

    Ventana Medical Systems is recalling 763 Ventana HE 600 automated slide preparer instruments used in laboratories worldwide due to potential fluid leaks that could cause electrical shorts and fire.

    Product
    Ventana HE 600 System, automated slide preparer, for use in laboratories.
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1346-2022·2022-07-20

    CoolMax ZELTIQ Vacuum Applicator recalled for paradoxical hyperplasia complaints

    Zeltiq Aesthetics is voluntarily discontinuing 2,945 CoolMax ZELTIQ Vacuum Applicators due to an increase in paradoxical hyperplasia complaints between 2019 and 2021, an adverse event causing unwanted tissue growth instead of intended fat reduction.

    Product
    CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1365-2022·2022-07-20

    Neonatal Transport System Oxygen Supply Component Pressure-Rating Defect

    Draeger Medical is recalling neonatal transport systems because an oxygen supply component is not rated for the system's working pressure. This affects 38 units distributed internationally but not in the United States.

    Product
    Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1382-2022·2022-07-20

    Vivo 45LS Ventilator processor failure alarm not generated on shutdown

    Breas Medical recalls 1,113 Vivo 45LS Ventilators due to a processor that can fail without triggering an alarm, potentially preventing detection of ventilator malfunction if monitoring instructions are not followed.

    Product
    Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Model Number: 230000 ¿ If the recalled product is a software, include version number: firmware versions 5.0.5 or earlier
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1383-2022·2022-07-20

    Aesculap Micro Needleholder Recalled for Incorrect Size Labeling

    Aesculap Implant Systems LLC is recalling TC Cooely Micro Needleholder instruments because units labeled as 200mm are actually 150mm. This labeling error could impact surgical procedures.

    Product
    AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1329-2022·2022-07-20

    Radiography system firmware defect causes incorrect radiation dose

    Philips DigitalDiagnost C90 radiography systems have a firmware defect that may cause incorrect radiation doses and anatomic marker misalignment. The issue affects 140 systems nationwide with specific serial numbers.

    Product
    DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1352-2022·2022-07-20

    MiniMed 620G insulin pump battery cap deterioration may cause power loss

    Medtronic MiniMed 620G insulin pumps may experience battery cap deterioration, resulting in incomplete battery circuit and loss of power. Approximately 2,287 affected pumps have been distributed across the U.S.

    Product
    MiniMed 620G Insulin Pump (O.U.S. version)
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1381-2022·2022-07-20

    Ivenix Infusion System Devices Recalled for Alarm Sequencing Defect

    The Ivenix Infusion System may malfunction where an occlusion alarm is immediately followed by a pump problem alarm, potentially delaying proper identification of the issue. FDA is recalling 1,335 affected devices.

    Product
    Ivenix Infusion System (IIS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1370-2022·2022-07-20

    NATURALYTE Hemodialysis Dialysate Recalled Due to Unqualified Bottle Caps

    Fresenius Medical Care is recalling 656 cases of NATURALYTE Liquid Acid dialysate nationwide (lot 22CTAC106) because alternate bottle caps are not qualified for use, potentially compromising product integrity.

    Product
    NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-2251-0
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1359-2022·2022-07-20

    MiniMed 780G Insulin Pump battery cap deterioration may cause power loss

    Medtronic MiniMed is recalling 83,398 MiniMed 780G insulin pumps distributed throughout the United States due to battery cap deterioration that may cause power loss and device malfunction.

    Product
    MiniMed 780G Insulin Pump (O.U.S. Version)
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1371-2022·2022-07-20

    Hemodialysis Dialysate Recalled for Unqualified Bottle Caps

    Fresenius Medical Care is recalling NATURALYTE Liquid Acid dialysate because bottle caps are not qualified for use. The recall affects 163 cases of lot 22CTAC102 distributed nationwide.

    Product
    NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1327-2022·2022-07-20

    Radiography System Firmware Flaw May Cause Incorrect Image Orientation and Dose

    Philips DigitalDiagnost 4 Flex/Value radiography systems have a firmware issue in the Wallstand VS2 board that may cause incorrect image orientation and radiation dosing. The defect affects 140 systems distributed nationwide.

    Product
    DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1378-2022·2022-07-20

    Modular orthopedic prosthesis recall due to intraoperative component locking

    Waldemar Link is recalling Endo Model Modular Femur and Tibia orthopedic prostheses because the blind screws on the tibial component cannot be loosened during surgery, potentially prolonging procedures.

    Product
    Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.: X-Small, Right 15-3815/11, Small, Right 15-3816/11, Small, Left 15-3816/12, Medium, Right 15-3817/11, Medium, Left 15-3817/12, Large, Right 15-3818/11.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1380-2022·2022-07-20

    Tibial Prosthetic Component Recall: Blind Screws Cannot Be Loosened Intraoperatively

    Tibial prosthetic components have defective blind screws that may not loosen during surgery, requiring procedure changes. Approximately 3,785 units of models W 16-2817/32, 35, and 37 were distributed across the US and internationally.

    Product
    Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 Medium, W 16-2817/35 Large, W 16-2817/37
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1367-2022·2022-07-20

    Anti-SARS-CoV-2 IgG Reagent: Stability Time Overstated in Instructions

    Ortho-Clinical Diagnostics is recalling Anti-SARS-CoV-2 IgG Quantitative Reagent Pack because the Instructions For Use incorrectly state on-analyzer stability of 8 weeks when the actual supported time is 6 weeks.

    Product
    Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems. Product Code: 6199960
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1373-2022·2022-07-20

    Alcon Custom Pak Surgical Procedure Packs recalled for incorrect latex gloves

    Alcon has recalled 320 kits of Custom Pak Surgical Procedure Packs distributed across Arizona, California, Missouri, and New York because they contain latex gloves instead of the specified non-latex gloves, creating an allergen hazard for sensitive patients.

    Product
    Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE 18527-03 14JM57 DOSS CATARACT ALLIANCE EYE SURG PARTNERS 11802-07 14KFAF GANS BASIC PACK NOVAMED EYE SURG CTR 11
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1385-2022·2022-07-20

    HAMILTON-H900 Humidifier Recall Due to Delayed Low-Water Alarm

    Hamilton Medical's HAMILTON-H900 humidifier (models 950001, 950004) is recalled due to delayed low-water level alarms that may prevent medical staff from detecting an empty chamber during mechanical ventilation use.

    Product
    HAMILTON-H900 Humidifier, Models: 950001, 950004
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1354-2022·2022-07-20

    MiniMed 640G Insulin Pumps Recalled for Battery Cap Deterioration

    Medtronic has recalled approximately 323,417 MiniMed 640G insulin pumps due to battery cap deterioration that may cause loss of power and functionality. Patients should contact Medtronic or their healthcare provider immediately.

    Product
    MiniMed 640G Insulin Pump (O.U.S. Version)
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1372-2022·2022-07-20

    Blood gas test device recalled for inaccurate oxygen measurements

    Siemens epoc BGEM Test Cards may produce inaccurate blood oxygen measurements, potentially leading to misdiagnosis and unnecessary respiratory treatment. The recall affects 263 boxes distributed across multiple states.

    Product
    epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood Product Siemens SMN#/Model #: 10736515
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1347-2022·2022-07-20

    CoolCore ZELTIQ Vacuum Applicator Voluntarily Recalled Due to Paradoxical Hyperplasia

    Zeltiq Aesthetics is voluntarily recalling CoolCore ZELTIQ Vacuum Applicators due to increased reports of Paradoxical Hyperplasia, an adverse effect causing unwanted fat tissue growth. The recall affects 3,054 units distributed across the U.S. and internationally.

    Product
    CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1377-2022·2022-07-20

    Modular Orthopedic Implant Screws May Not Loosen During Surgery

    FDA recalls certain Endo Model orthopedic implants because the blind screws may not loosen during surgery, potentially requiring surgeons to change their approach and prolonging the procedure.

    Product
    Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic prosthesis.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1353-2022·2022-07-20

    MiniMed 630G Insulin Pump Recalled for Battery Cap Deterioration

    Medtronic MiniMed is recalling the MiniMed 630G insulin pump due to battery cap deterioration that may cause loss of power and function. Approximately 126,558 units distributed in the U.S. and Canada are affected.

    Product
    MiniMed 630G Insulin Pump (U.S. and Canada Version)
    Category
    Medical Device
    Distribution
    53 states