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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10226–10250 of 13717

  • HighFDA (Devices)·Z-0739-2023·2022-12-28

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

    Abbott Molecular is recalling specific lots of the Alinity m Resp-4-Plex Amp Kit due to reports of false positive and false negative test results.

    Product
    Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
    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-0761-2023·2022-12-28

    Revaclear 400 Dialyzer recall due to potential internal blood leaks

    Baxter Healthcare recalls Revaclear 400 Dialyzer units due to potential internal blood leaks caused by twisted gaskets. The defect may affect dialysis patients worldwide.

    Product
    Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by hemodialysis.
    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-0759-2023·2022-12-28

    Ultrasound System Batteries May Fail, Emit Smoke, or Catch Fire

    GE Medical Systems is recalling Vivid q N ultrasound systems due to potential battery failures that could emit smoke or catch fire if batteries are not replaced per the 2-year service manual recommendation.

    Product
    Vivid q 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-skelet
    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-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-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-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-0766-2023·2022-12-28

    Lamaze Chill Teether Recalled for Potential Microbial Growth in Fluid

    Lamaze Chill Teether teething rings are being recalled due to potential microbial growth in the internal fluid. This poses an infection risk, particularly for children with weakened immune systems.

    Product
    Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L
    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-0754-2023·2022-12-28

    Vivid S5 N Ultrasound Systems Recalled for Potential Battery Fire Hazard

    GE Medical Systems recalled 1,400 Vivid S5 N ultrasound systems for batteries that may fail, emit smoke, or catch fire if not replaced every 2 years as recommended.

    Product
    Vivid S5 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-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-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-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-0742-2023·2022-12-28

    HeartWare Model 1100 driveline cover hardening may delay urgent access

    HeartWare Model 1100 driveline covers may harden over time, making it difficult or impossible to access the driveline-to-controller connector. A delay in accessing the connector during an urgent issue could result in prolonged pump stoppage and patient harm.

    Product
    HeartWare Model 1100
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0729-2023·2022-12-28

    GE Patient Monitors May Display Inaccurate CO2 Readings at Non-Sea-Level Locations

    GE Healthcare is recalling certain B105P patient monitors because they may display inaccurate CO2 measurements when used in locations not at or near sea level with mmHg or kPa units selected.

    Product
    B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0737-2023·2022-12-28

    Tobra Bone Cement Recall for Missing Turkish Instructions

    Howmedica Osteonics is recalling Tobra bone cement because packaging instructions lack Turkish language translation, though the instructions themselves are accurate. The recall affects 20 units distributed internationally.

    Product
    Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0736-2023·2022-12-28

    Bone Cement Recall: Missing Turkish Language Instructions for Use

    Howmedica Osteonics Corp. is recalling Full Dose CE Simplex P Single Bone Cement because the included instructions for use lack Turkish language translations. The product content itself is accurate; only the language translation is missing.

    Product
    Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0725-2023·2022-12-28

    Intradental periodontal picks recalled for mislabeling by Young Dental

    Young Dental Manufacturing has recalled Denticator PICK-A-DENT intradental picks due to mislabeling. The recall affects 600 packs distributed in Iowa, New York, Pennsylvania, Tennessee, Texas, and Canada.

    Product
    Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714
    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-0429-2023·2022-12-21

    Arrow AutoCAT2 cardiac pump recalled for short battery run-times

    Arrow International is recalling 2,678 Arrow AutoCAT2 intra-aortic balloon pumps worldwide due to a potential issue with short battery run-times. The FDA classified this as a Class I recall.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0452-2023·2022-12-21

    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump Recalled for Battery Runtime Issues

    Arrow International is recalling 127 units of the AutoCAT2WAVE Intra-Aortic Balloon Pump worldwide due to a potential issue with battery runtime.

    Product
    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000325), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0449-2023·2022-12-21

    Intra-Aortic Balloon Pump with Potential Short Battery Run-Times

    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pumps are being recalled worldwide due to short battery run-times affecting device operation. Patients using this device should contact their healthcare provider immediately.

    Product
    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500EX (IPN000322), cardiac pump
    Category
    Medical Device
    Distribution
    0 states