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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8401–8425 of 40007

  • ModerateFDA (Devices)·Z-0619-2024·2024-01-03

    Liberty Select Cycler Displays Incorrect Timestamp on Treatment Reports

    Certain Liberty Select Cycler hemodialysis machines may display an incorrect timestamp on treatment data reports sent to clinics. No injuries or illnesses have been reported.

    Product
    Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0513-2024·2023-12-27

    FDA Recalls Sterile Water and Saline Bottles for Sterility Assurance Issues

    Nurse Assist, LLC is recalling sterile water and saline bottles across multiple brands due to potential lack of sterility assurance. The products could be nonsterile and may cause infection.

    Product
    Sterile Water/Saline: Brand Name: Product Name/Product Code: CARDINAL: 100ML STERILE SALINE BOTTLE/1020, 100ML STERILE SALINE BOTTLE/1022, 100ML STERILE WATER BOTTLE/1024, 100ML STERILE WATER BOTTLE/10000, 100ML STERILE WATER BOTTLE/PT00103419, 100ML STERILE SALINE BOTTLE/PT001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0549-2024·2023-12-27

    Infusion pump recalled for mechanical valve interference interrupting therapy delivery

    Ivenix infusion pump may experience mechanical interference on fluid valve pins, interrupting therapy delivery. FDA recalled 938 units in five states due to potential risk of serious patient harm.

    Product
    Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0536-2024·2023-12-27

    ResMed AirFit N10 Nasal Masks Recalled for Magnetic Interference with Medical Implants

    ResMed is recalling AirFit N10 Nasal Masks because magnets in the masks may interfere with active medical implants. Patients with such implants should consult their healthcare provider before using these masks.

    Product
    AirFit N10 Nasal Masks and User Guide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0542-2024·2023-12-27

    AirFit F30i Full Face Mask Recalled Due to Magnetic Interference Risk

    ResMed is recalling the AirFit F30i Full Face Mask due to potential magnetic interference with active medical implants and ferromagnetic objects. Safety warnings are being updated.

    Product
    AirFit F30i Full Face Mask and User Guide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0538-2024·2023-12-27

    AirTouch F20 Full Face Mask Recalled for Magnetic Interference with Medical Implants

    ResMed recalls 3.8 million AirTouch F20 full face masks with magnets that may interfere with active medical implants. Updated safety warnings regarding safe distances from medical devices are being issued.

    Product
    AirTouch F20 Full Face Mask and User Guide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0511-2024·2023-12-27

    IV Flush Syringes and Irrigation Solutions Recalled for Sterility Defect

    Nurse Assist, LLC recalls sodium chloride irrigation solutions and IV flush syringes due to potential lack of sterility assurance, which could allow contamination and infections.

    Product
    0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV FLUSH SYRINGE/1205-BP, 10ML IV FLUSH SYRINGE/1210-BP; SOL: 0.9% SODIUM CHLORIDE IV FLUSH SYRINGE/PFF001; HALYARD OWENS MINOR: 0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0541-2024·2023-12-27

    AirFit F30 Full Face Mask recalled for magnetic interference with medical implants

    ResMed is recalling the AirFit F30 Full Face Mask because the device contains magnets that can interfere with active medical implants and ferromagnetic objects. The original user guide did not adequately warn about safe distance requirements.

    Product
    AirFit F30 Full Face Mask and User Guide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0515-2024·2023-12-27

    Sterile Water Syringes recalled for lack of sterility assurance

    Nurse Assist LLC recalls sterile water injection and irrigation syringes for inadequate sterility assurance. Affected products may be nonsterile and could cause infection if used.

    Product
    Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE PREFILLED 10 ML/6496722, 30CC PREFILLED SYRINGE/6496723, USP STERILE WATER SYRINGE/1030, 10CC PREFILLED SYRINGES/51638, 30CC PREFILLED SYRINGES/52333, 10CC PREFILLED SYRINGES/1010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0539-2024·2023-12-27

    AirFit N20 Nasal Mask: Magnetic Interference with Medical Implants

    ResMed AirFit N20 Nasal Masks contain magnets that may interfere with active medical implants and ferromagnetic objects. The FDA classified this as Class I; ResMed is updating safety warnings with required distances.

    Product
    AirFit N20 Nasal Mask and User Guide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0512-2024·2023-12-27

    Sodium Chloride IV Flush Kits Recalled for Potential Sterility Failure

    Nurse Assist recalls sodium chloride IV flush solutions due to potential loss of sterility assurance. Nonsterile solutions could cause infection when used for intravenous administration.

    Product
    0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0514-2024·2023-12-27

    Sterile Water and Saline Products Recalled for Lack of Sterility Assurance

    Nurse Assist is recalling sterile water and saline irrigation products due to lack of sterility assurance. Use of nonsterile products could result in infection.

    Product
    Sterile Water/Saline: Product Name/Product Code: CUP STERILE WATER¿ FOIL LID 120 ML/T167005; CUP STERILE SALINE FOIL LID 120 ML/T167007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0540-2024·2023-12-27

    AirTouch N20 Nasal Mask recalled for magnetic interference with medical implants

    ResMed is recalling 424,309 units of AirTouch N20 Nasal Masks because they contain magnets that may interfere with active medical implants and ferromagnetic materials. Updated safety warnings are being provided.

    Product
    AirTouch N20 Nasal Mask and User Guide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0537-2024·2023-12-27

    AirFit F20 Full Face Mask recalled for magnetic interference with medical implants

    ResMed is recalling AirFit F20 Full Face Masks due to magnets that can interfere with active medical implants. Updated warnings will guide safe distances for patients and those in close contact.

    Product
    AirFit F20 Full Face Mask and User Guide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0601-2024·2023-12-27

    Siemens epoc NXS Blood Analysis System Software Causes Erroneous Test Results

    Siemens epoc NXS blood analysis systems have a software defect causing incorrect test results to be printed or transmitted. Results may include data from previous patients, potentially leading to misdiagnosis.

    Product
    epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software versions from 4.9.4 to the current version 4.11.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0574-2024·2023-12-27

    Injection needles recalled due to cleaning efficacy concerns

    Karl Storz Endoscopy is recalling injection needles used in general and visceral surgery due to concerns that the manual cleaning process cannot ensure adequate sterilization, which may increase infection risk.

    Product
    Injection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, single cvd. 80 degrees, REF: 738752; Injection Needle, bayonet, 13 cm, REF: 738756; Injection Needle, angular, 13 cm, REF: 738758; Needle, bayonet-shaped, REF: 810505; Needle, Septum, angular, REF: 810506
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0575-2024·2023-12-27

    Surgical Injection Needles Recalled for Uncertain Manual Cleaning Efficacy

    Karl Storz Endoscopy injection needles used in surgery may not be reliably cleaned by hand, exposing patients to higher infection risk. The recall affects 4,878 units.

    Product
    Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF: 8598B; Injection Needle, distal 45-degrees, 23 cm, REF: 8598D
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0565-2024·2023-12-27

    CardioQuip Modular Cooler-Heater Device Recalled for Potential Bacterial Contamination

    CardioQuip is recalling the Modular Cooler-Heater (Model MCH-1000i) due to potential bacterial contamination that could cause patient infection. Four units were distributed in California, Texas, Pennsylvania, Washington, Ohio, and Nebraska.

    Product
    CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0580-2024·2023-12-27

    Exactech Equinoxe Shoulder System recalled for loss of vacuum

    Exactech is recalling specific models of its Equinoxe Shoulder System implants due to loss of vacuum in the inner-most vacuum bag. Four devices have been affected according to three complaints received.

    Product
    Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, e) 314-23-15, f) 314-24-22, g) 314-24-23, h) 314-24-24, i) 314-24-32, j) 314-24-33, k) 314-24-34, l) 314-24-35
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0573-2024·2023-12-27

    Injection Needles Recalled for Inadequate Manual Cleaning Process

    Karl Storz is recalling 1,127 injection needles used in general and visceral surgery because the manual cleaning process cannot be adequately assured, potentially increasing infection risk for patients.

    Product
    Injection Needle, LUER-lock,0.8mm, REF: 26175PD
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0606-2024·2023-12-27

    RAPIDPoint 500 Measurement Cartridges Recalled for Sodium Sensor Bias

    Siemens is recalling RAPIDPoint 500 Systems Measurement Cartridges because the sodium sensor can develop a negative measurement bias that could delay diagnosis of serious electrolyte disorders or cause treatment errors.

    Product
    RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10844813
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0589-2024·2023-12-27

    Acrobat-i Vacuum Positioner System Recalled for Positioner Arm Locking Failure

    Maquet Cardiovascular is recalling the Acrobat-i Vacuum Positioner System because the positioner arm may fail to tighten or lock during normal use, which could affect surgical positioning.

    Product
    Acrobat-i Vacuum Positioner System, Model Number XP-5000Z
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0581-2024·2023-12-27

    Exactech Novation Hip System Recalled for Vacuum Seal Loss

    Exactech is recalling the Novation Hip System due to loss of vacuum in the sterile packaging. The company has received complaints about this defect affecting 4 devices.

    Product
    Exactech Novation Hip System, Catalog Numbers: 134-36-45
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0584-2024·2023-12-27

    Exactech Optetrak Logic PS Knee System Vacuum Loss Recall

    Exactech is recalling certain Optetrak Logic PS Knee Systems due to potential loss of vacuum in the inner-most vacuum bag. The company has received 3 complaints involving 4 devices.

    Product
    Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0567-2024·2023-12-27

    AC Power Adapter for LIFEPAK 15 Defibrillator May Fail to Charge or Power On

    AC power adapters for LIFEPAK 15 Monitor/Defibrillators may fail to charge batteries or power on the device. Physio-Control is recalling 18,732 units manufactured between November 2021 and April 2023.

    Product
    AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
    Category
    Medical Device
    Distribution
    Distributed nationwide