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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8826–8850 of 27441

  • HighFDA (Devices)·Z-0733-2023·2022-12-28

    GE B125M Patient Monitor CO2 Measurement Inaccuracy at High Altitude

    GE Healthcare is recalling B125M patient monitors because the CO2 measurement display can be inaccurate at locations above sea level when configured for mmHg or kPa units.

    Product
    B125M Patient Monitor, REF 6160000-005-XXXXXXX
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0752-2023·2022-12-28

    GE Vivid S5 Ultrasound Systems Battery Failure Fire Risk

    GE Medical Systems is recalling Vivid S5 ultrasound systems because batteries may fail if not replaced at the recommended 2-year intervals, potentially causing smoke or fire.

    Product
    Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superf
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0756-2023·2022-12-28

    GE Vivid i Ultrasound Systems Battery Failure Recall

    GE Medical Systems is recalling Vivid i ultrasound systems because batteries not replaced every two years may fail, emit smoke, or catch fire. About 7,931 units were distributed worldwide.

    Product
    Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cepha
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0726-2023·2022-12-28

    Corin BIOLOX DELTA Ceramic Hip Implant Heads Recalled for Incorrect Size Labeling

    Corin Ltd is recalling BIOLOX Delta Ceramic Hip Implant Heads nationwide due to size labeling errors. The 36XL size is labeled as 32XL and vice versa, which could result in implantation of an incorrectly sized component.

    Product
    Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0734-2023·2022-12-28

    Fresenius 2008T Hemodialysis Machines Recalled for False USB Device Alarm

    Fresenius Medical Care is recalling 2008T and 2008T Bluestar Hemodialysis Machines with CDX due to a software and hardware sensitivity to electromagnetic interference that triggers false alarms.

    Product
    2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX ; (3) 191124
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0722-2023·2022-12-28

    GE Centricity Universal Viewer 6.0 Medical Imaging Software May Hide Studies

    GE Medical Systems' Centricity Universal Viewer 6.0 image display software may hide medical studies from users after IAS tool installation, requiring GE assistance to access hidden images and causing delays in reading diagnostic studies.

    Product
    Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0765-2023·2022-12-28

    Medical Action Industries Littauer Scissors Recalled for Debris Contamination

    Medical Action Industries is recalling Littauer surgical scissors because the sterile instruments may contain debris that could compromise their safety during clinical use.

    Product
    Medical Action Industries Inc. Disposable Instrument Pack, Littauer Scissor, REF 56247, packaged 1/package, 20 packages/box, 12 boxes/case, sterile.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0764-2023·2022-12-28

    Baxter Revaclear 400 Dialyzers Recalled for Polyurethane Displacement

    Baxter Healthcare is recalling Revaclear 400 dialyzers because polyurethane displacement may cause blood leaks during dialysis treatment. Approximately 1.14 million units are affected worldwide.

    Product
    Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0757-2023·2022-12-28

    GE Vivid q Ultrasound Systems: Battery Fire Risk Recall

    GE is recalling Vivid q ultrasound systems because batteries not replaced every 2 years as recommended may fail and emit smoke or catch fire.

    Product
    Vivid q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superfi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0731-2023·2022-12-28

    GE B105M Patient Monitor displays inaccurate CO2 readings at altitude

    GE Medical Systems is recalling B105M patient monitors that display inaccurate CO2 readings when used at elevations above sea level. The issue affects monitors showing CO2 in mmHg or kPa units.

    Product
    B105M Patient Monitor, REF 6160000-003
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0740-2023·2022-12-28

    Abbott Alinity m Resp-4-Plex Amp Kit Recalled for False Positive Results

    Abbott Molecular is recalling approximately 12,116 units of the Abbott Alinity m Resp-4-Plex Amp Kit due to reports of false positive results and reactive negative controls. No illnesses or injuries have been reported.

    Product
    Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0741-2023·2022-12-28

    InPen Diabetes App crashes, preventing dose reminders

    The InPen Diabetes Management App may crash on certain Android versions, preventing dose reminders and potentially delaying insulin therapy. This could affect users of the diabetes management system.

    Product
    InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT-105ELGYNA, MMT-105ELPKNA, MMT-105ELPKNA, MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0749-2023·2022-12-28

    HeartWare HVAD ventricular assist pump driveline cover hardening recall

    HeartWare HVAD ventricular assist pump kits may develop hardened driveline covers that impair access to critical connectors. If urgent servicing is needed, delayed access could result in patient harm from prolonged pump stoppage.

    Product
    HeartWare HVAD Pump Kit, REF 1205
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0457-2023·2022-12-28

    SurfaceSoap UV Disinfecting Wand Recalled for Excessive Ultraviolet Radiation

    PhoneSoap has recalled its SurfaceSoap UV Disinfecting Wand due to excessive ultraviolet-C radiation emission. Approximately 6,700 units distributed nationwide may pose a radiation hazard to users.

    Product
    The product is a handheld ultraviolet-C germicidal wand and contains narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0746-2023·2022-12-28

    HeartWare HVAD Pump Kit Driveline Cover Hardening Issue

    HeartWare HVAD Pump Kit driveline covers may harden over time, making it difficult or impossible to access the driveline connector for urgent servicing. Delayed access could result in patient harm from prolonged pump stoppage.

    Product
    HeartWare HVAD Pump Kit, REF 1104
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0753-2023·2022-12-28

    GE Vivid S6 Ultrasound Systems Recalled for Battery Fire Risk

    GE Vivid S6 ultrasound systems are recalled for a potential battery hazard. If not replaced at the recommended 2-year interval, batteries may fail, emit smoke, or catch fire.

    Product
    Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superf
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0738-2023·2022-12-28

    Spinal implant insert may fail to disengage from vertebral body device

    NuVasive's X-CORE 2 spinal implants may not disengage properly from the vertebral replacement device, potentially requiring revision surgery. About 2,031 devices worldwide are affected.

    Product
    X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0755-2023·2022-12-28

    GE Vivid S6 N Ultrasound Battery Fire Risk Recall

    GE Vivid S6 N ultrasound systems may experience battery failure, smoke, or fire if batteries are not replaced every 2 years as recommended. Clinicians should replace batteries per manufacturer Service Manual instructions.

    Product
    Vivid S6 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0721-2023·2022-12-28

    Medical Imaging Software Update May Hide Patient Studies

    After installing the IAS tool, Centricity PACS-IW Universal Viewer version 5.0 may hide some medical imaging studies without notification. Accessing hidden studies requires GE Healthcare assistance and may cause diagnostic delays.

    Product
    Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data from various imaging sources.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0751-2023·2022-12-28

    FDA Class II recall: Medical Action cardiac catheter introduction kit

    Medical Action Industries' Port a Cath Kit (cardiac catheter introduction kit) has been subject to an FDA Class II recall affecting 198 cases distributed in Virginia. The specific reason for recall was not provided by the FDA.

    Product
    Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0735-2023·2022-12-28

    Natus Cranial Access Kit Recalled Due to Defective Sterile Surgical Drapes

    Natus Medical is recalling 249 Cranial Access Kits distributed nationwide. The sterile surgical drape liners are difficult to remove without damage, potentially rendering the kits unusable for neurosurgical procedures.

    Product
    The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to create an intracranial burr-hole typically required for procedures such as ventriculostomy or intracranial pressure (ICP) monitoring. The various
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0758-2023·2022-12-28

    Vivid i N ultrasound device batteries may fail, smoke, or catch fire

    GE Medical Systems recalls Vivid i N ultrasound machines worldwide because unreplaced batteries may fail, emit smoke, or catch fire. Users should replace batteries every 2 years per the service manual.

    Product
    Vivid i N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0438-2023·2022-12-21

    Arrow AC3 Optimus IABP recalled for shortened battery run-times

    Arrow AC3 Optimus Intra-Aortic Balloon Pump (IABP) devices are recalled worldwide due to a potential issue with shortened battery run-times. All lot and serial numbers of model IAP-0700 are affected.

    Product
    Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0434-2023·2022-12-21

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Battery Run-Time Issue

    ARROW INTERNATIONAL is recalling Arrow AutoCAT2 Intra-Aortic Balloon Pumps due to a potential issue with short battery run-times. Affected devices distributed worldwide may have reduced battery endurance.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN917287), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0444-2023·2022-12-21

    Arrow AutoCAT 2 Intra-Aortic Balloon Pump Short Battery Runtime Recall

    Arrow International is recalling the Arrow AutoCAT 2 Intra-Aortic Balloon Pump (IABP) due to a potential issue with short battery run-times. The recall affects 29 units distributed worldwide.

    Product
    Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305), cardiac pump
    Category
    Medical Device
    Distribution
    0 states