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 the agency’s own highest classification or reported deaths or serious injuries, 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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26201–26225 of 40357

  • HighFDA (Devices)·Z-2726-2017·2017-07-19

    Natus Neurology Recalls Elite 2 MHz OB Probes Due to Excessive Noise

    Natus Neurology is recalling 2,335 Elite 2 MHz OB probes because excessive background noise may mask the user's ability to hear heart rate or blood flow.

    Product
    Nicolet¿ Elite¿ 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog Code: N200. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2722-2017·2017-07-19

    ICU Medical Recalls 10-Inch Smallbore Extension Sets Due to Leak Risk

    ICU Medical is recalling 900 units of 10-inch smallbore extension sets because the connection between the Female Luer and the NanoClave manifold may develop a leak.

    Product
    10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2724-2017·2017-07-19

    ICU Medical Recalls 10-Inch Smallbore Extension Sets Due to Leak Risk

    ICU Medical is recalling 100 units of 10-inch smallbore extension sets because the connection between the Female Luer and the NanoClave manifold may develop a leak.

    Product
    10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, 0.2 Micron Filter, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2716-2017·2017-07-19

    ICU Medical Recalls 18 cm Smallbore Extension Sets Due to Leak Risk

    ICU Medical is recalling 304 units of 18 cm Smallbore Extension Sets because the connection between the Female Luer and NanoClave manifold may leak.

    Product
    18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2732-2017·2017-07-19

    Nova Biomedical Stat Profile Prime Analyzer Software Recall

    Nova Biomedical is recalling Stat Profile Prime Analyzers because a software defect could cause scheduled quality control tests to overwrite pending patient results.

    Product
    Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG Analyzer with Scanner PN 52856 Stat Profile Prime CCS Analyzer PN 53656 Stat Profile Prime CCS Analyzer with Scanner PN 53657 Stat Profile Prime…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2693-2017·2017-07-19

    St. Jude Medical Recalls Infinity 5 Implantable Pulse Generators

    St. Jude Medical is recalling 443 Infinity 5 Implantable Pulse Generators due to a risk of losing neuromodulation therapy when exposed to monopolar electrosurgical devices.

    Product
    Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2683-2017·2017-07-19

    ICU Plum A+ Infusion Systems Recalled for Battery-Related Therapy Interruption

    ICU is recalling 363,892 Plum A+ Infusion Systems because battery issues can cause an E321 error code, potentially interrupting patient therapy.

    Product
    The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2692-2017·2017-07-19

    St. Jude Medical Recalls Proclaim 7 Elite Implantable Pulse Generators

    St. Jude Medical is recalling 9,529 Proclaim 7 Elite implantable pulse generators due to a risk of losing neuromodulation therapy when exposed to monopolar electrosurgical devices.

    Product
    Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2712-2017·2017-07-19

    Toshiba APLIO i-series Ultrasound Systems Recalled for Incorrect Velocity Readings

    Toshiba is recalling 28 APLIO i-series diagnostic ultrasound systems because they may display incorrect velocity values when using the Continuous Trace method.

    Product
    APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 diagnostic ultrasound system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2714-2017·2017-07-19

    ArjoHuntleigh Flowtron ACS900 Medical Pump Recalled for Deflation Failure

    Arjo, Inc. is recalling 40,675 Flowtron ACS900 medical pumps worldwide because the device may fail to deflate the calf garment as intended without triggering an alarm.

    Product
    ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used to prevent the occurrence of Deep Vein Thrombosis (DVT) in at-risk patients. The system must be used as part of a prescribed plan of car under the supervision of trained medical and/or Clinical staff.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2698-2017·2017-07-19

    Arrow Recalls EVOLUTION Pressure Injectable PICC Catheters Due to Hub Tab Detachment

    Arrow International is recalling EVOLUTION Pressure Injectable PICC catheters because the peel-away component hub tabs may prematurely detach during use.

    Product
    Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2721-2017·2017-07-19

    ICU Medical Recalls MicroClave Extension Sets Due to Leak Risk

    ICU Medical is recalling 100 units of MicroClave extension set kits because the connection between the Female Luer and the NanoClave manifold may develop a leak.

    Product
    Kit w/3 Ext Sets, 3 Drop-In MicroClave¿ Clear. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2727-2017·2017-07-19

    Natus Neurology Recalls Elite Obstetric Probes Due to Excessive Background Noise

    Natus Neurology is recalling 2,335 Elite Obstetric probes because excessive background noise may mask fetal heart rate and blood flow monitoring.

    Product
    Nicolet¿ Elite¿ 2 MHz OB Water Proof Probe, Model #: X1L008, Catalog Code: NW20. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.
    Category
    Medical Device
    Distribution
    44 states
  • ModerateFDA (Devices)·Z-2711-2017·2017-07-19

    Toshiba APLIO 500 Ultrasound Systems Recalled for Incorrect Velocity Trace Values

    Toshiba American Medical Systems Inc. is recalling 307 APLIO 500 diagnostic ultrasound systems because they may display incorrect values when using the Continuous Trace method on Spectral Doppler.

    Product
    APLIO 500 TUS-A500 diagnostic ultrasound system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2706-2017·2017-07-19

    Fujifilm Recalls Ultrasonic Endoscope Model EG-530UT

    Fujifilm Medical Systems is recalling four units of the EG-530UT ultrasonic endoscope following a retrospective review.

    Product
    Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2708-2017·2017-07-19

    Toshiba XARIO 100 Ultrasound Systems Recalled for Incorrect Velocity Readings

    Toshiba American Medical Systems is recalling seven XARIO 100 diagnostic ultrasound systems because they may display incorrect values when using the Continuous Trace method for velocity measurements.

    Product
    XARIO 100 TUS-X100 diagnostic ultrasound system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2730-2017·2017-07-19

    Beckman Coulter Synchron AQUA CAL Level 1 Calibration Kits Recalled

    Beckman Coulter is recalling Synchron AQUA CAL Level 1 kits due to a sodium recovery shift that may affect system calibration.

    Product
    Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea, Glucose Creatine, Ca, CO2, and P in UniCel DxC Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2715-2017·2017-07-19

    CryoLife On-X Prosthetic Heart Valve Recall for Incorrect Labeling

    CryoLife, Inc. is recalling 52 On-X Prosthetic Heart Valves because the sewing ring type was mislabeled as Standard instead of Anatomic.

    Product
    On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2701-2017·2017-07-19

    Natus Medical Recalls Olympic Pasteurmatic 3000 and 3500 Disinfection Systems

    Natus Medical is recalling Olympic Pasteurmatic 3000 and 3500 systems because they do not fully meet current regulatory requirements due to design age and component obsolescence.

    Product
    The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy and anesthesia equipment by killing vegetative bacteria and viruses, in a hot water bath at ~160¿ - ~170¿ F for 30 minutes. Catalog…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2725-2017·2017-07-19

    AMS Diagnostics Recalls Medica ISE Module Calibrant A Due to Physical Defects

    AMS Diagnostics is recalling 9 units of Medica ISE Module Calibrant A because the lot was not functioning properly and did not exhibit correct physical properties.

    Product
    Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Module; Product Usage: Calibrations of ISE Model for integrated electrolyte system analysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2657-2017·2017-07-12

    CardioTek EP-TRACER Software Recalled for Unintentional Parameter Changes

    CardioTek BV is recalling EP-TRACER Software V1.x and V2.0 due to a bug that allows parameters to be changed unintentionally during use.

    Product
    CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user…
    Category
    Medical Device
    Distribution
    Distributed nationwide