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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25501–25525 of 27686

  • HighFDA (Devices)·Z-0813-2014·2014-01-29

    Churchill Medical AMS-530 Microbore Extension Sets Recalled for Leaking

    Churchill Medical Systems is recalling AMS-530 Microbore Trifurcated Extension sets because a defective component may cause the sets to leak.

    Product
    AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0807-2014·2014-01-29

    GE Healthcare Patient Data Module Recall for ECG Noise

    GE Healthcare is recalling 2,516 Patient Data Modules due to intermittent noise on ECG and respiration waveforms that may reduce monitoring performance.

    Product
    SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0816-2014·2014-01-29

    Radiometer ABL90 FLEX Analyzer Recalled for Potential Sodium Measurement Bias

    Radiometer America Inc is recalling ABL90 FLEX analyzers because tilting the device may cause negative bias in sodium results.

    Product
    ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 Br¿nsh¿j, Denmark A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-0797-2014·2014-01-29

    Carestream DRX-Evolution and Kodak DirectView DR 7500 Recalled for Movement Risk

    Carestream Health is recalling DRX-Evolution and Kodak DirectView DR 7500 x-ray systems due to potential unexpected device movement.

    Product
    DRX-Evolution with CSH WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0787-2014·2014-01-29

    Siemens Linac Treatment Table Recall for Finger Pinch and Cable Damage

    Siemens is recalling 305 linear accelerator treatment tables due to risks of finger pinching and cable short-circuits.

    Product
    PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table. TT-A, TT-D, TT-M or TT-S Table tops. Manufactured by: SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse 19-21 Kemnath, GERMANY 95478 The intended use of the SIEMENS branded, ARTISTE", ONCOR"…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0790-2014·2014-01-29

    BD GeneOhm Cdiff Assay Recalled Due to Incorrect Reagent Packing

    Becton Dickinson is recalling 33 kits of the BD GeneOhm Cdiff Assay because an incorrect reagent was packed, which may cause false negative results for C. difficile.

    Product
    BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as ***GeneOhm Sciences Canada, Inc. 2555 boul. du Parc-Technologique Quebec, Qc, Canada, G1P 4S5*** The BD GeneOhm" Cdiff Assay is a rapid in vitro diagnostic test for…
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0809-2014·2014-01-29

    CryoLife Pulmonary Hemi-Artery SG Recalled Due to Donor Testing Concerns

    CryoLife, Inc. is recalling one Pulmonary Hemi-Artery SG device used in heart surgery because donor serological testing may have been compromised by hemodilution.

    Product
    Pulmonary Hemi-Artery SG Used in heart surgery
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0798-2014·2014-01-29

    Carestream DRX-Evolution and Kodak DirectView DR 7500 X-Ray Systems Recalled

    Carestream Health is recalling DRX-Evolution and Kodak DirectView DR 7500 diagnostic x-ray systems due to a potential for unexpected device movement.

    Product
    DR 7500 with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0805-2014·2014-01-29

    Sorin Orchestra Programmer Overestimates Pacemaker Battery Life

    Sorin Group Italia is notifying physicians that its Orchestra programmer may overestimate the residual longevity of specific implanted pacemakers.

    Product
    ORCHESTRA/ORCHESTRA PLUS Programmer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0785-2014·2014-01-29

    Philips Recalls ADAC Gamma Camera Systems Due to Fork Joint Crack Risk

    Philips Medical Systems is recalling ADAC ARGUS and CIRRUS Gamma Camera Systems because routine maintenance may fail to detect small cracks in the fork weldments.

    Product
    ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distributed by Philips Medical Systems, Cleveland, OH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0808-2014·2014-01-29

    GE Healthcare Recalls TRAM Modules Due to Intermittent ECG Noise

    GE Healthcare is recalling 1,948 TRAM Modules because movement of the ECG cable connector causes intermittent noise on ECG and respiration waveforms, potentially reducing monitoring performance.

    Product
    GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0782-2014·2014-01-29

    Ranir Recalls UP & UP Kids' Power Toothbrushes Due to Choking Hazard

    Ranir is recalling UP & UP and TopCare kids' power toothbrushes because the tufted disk may detach, posing a choking hazard to children three and younger.

    Product
    UP & UP kids' power toothbrush
    Category
    Consumer Product
    Distribution
    2 states
  • HighFDA (Devices)·Z-0810-2014·2014-01-29

    Medrad Recalls Veris MR Monitor Units Due to Faulty Main Board

    Medrad is recalling 922 Veris MR Monitor units because a faulty main board may cause unexpected system shutdowns, resulting in the loss of vital signs information.

    Product
    Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional healthcare provider. Physiological data, gas…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0823-2014·2014-01-29

    Siemens CentraLink Software Recall for Potential Patient Data Release Error

    Siemens is recalling CentraLink Data Management System software versions 14.0.4, 14.0.5, and 14.0.8 because a disabled patient result may be released without proper review.

    Product
    Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0786-2014·2014-01-29

    Siemens Recalls SimView NT Radiation Therapy Simulation Systems

    Siemens is recalling 65 SimView NT radiation therapy simulation systems worldwide because a rare mechanical failure could prevent the stopping of intended component movements.

    Product
    SIMVIEW NT and SIMVIEW NT with IDI: October 01, 2012 Siemens ceased Simview distribution. Manufactured by: Mecaserto now known as Mecasim Parc de lEsplanade 9,Rue Niels Bohr 77400 Saint Thibault des Vignes- France The intended use of the SIEMENS branded SIMVIEW NT…
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0804-2014·2014-01-29

    GE Healthcare Recalls X-Ray Systems with Missing Monitor Suspension Screws

    GE Healthcare is recalling 5,651 X-ray systems worldwide because four outer screws holding the overhead video monitor suspension may be missing. No monitor falls have been reported.

    Product
    Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray systems: Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Prestige SII Product Usage: The systems are intended to be used as a universal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0818-2014·2014-01-29

    Siemens Recalls Dimension Vista Cyclosporine Flex Reagent Cartridges

    Siemens Healthcare Diagnostics is recalling 1,586 Dimension Vista Cyclosporine Flex reagent cartridges due to complaints about variability in quality control and patient results.

    Product
    Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements are used as an aid in the management of heart, liver, and kidney…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0796-2014·2014-01-29

    Carestream DRX-Evolution X-Ray Systems Recalled for Unexpected Movement

    Carestream Health is recalling DRX-Evolution and Kodak DirectView DR 7500 systems due to a risk of unexpected device movement.

    Product
    DRX-Evolution with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0781-2014·2014-01-29

    Ranir Recalls TopCare and Up & Up Kids Power Toothbrushes

    Ranir is recalling TopCare and Up & Up kids' power toothbrushes because the tufted disk may detach, posing a choking hazard to children three and younger.

    Product
    TopCare Clifford THE BIG RED DOG power toothbrush for kids!
    Category
    Consumer Product
    Distribution
    2 states
  • HighFDA (Devices)·Z-0806-2014·2014-01-29

    GE Healthcare Recalls Dash Patient Monitors Due to ECG Noise

    GE Healthcare is recalling Dash 3000, 4000, and 5000 patient monitors because cable movement causes intermittent noise on ECG and respiration waveforms, potentially reducing detection performance.

    Product
    GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. K073462: The Dash 3000/4000/5000 patient monitor is intended for use under the direct…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0714-2014·2014-01-22

    Draeger Infinity Acute Care System Recall for Alarm Failure

    Draeger Medical Systems is recalling 439 Infinity Acute Care System units because a high-grade SpO2 alarm may fail to activate after a medium-grade alarm is paused.

    Product
    Draeger Infinity Acute Care System Monitoring Solution
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-0726-2014·2014-01-22

    Anspach Carbide Cutting Burrs Recalled Due to Fracture During Use

    The Anspach Effort, Inc. is recalling specific carbide cutting burrs because some fractured during use. The products are intended for cutting and shaping bone.

    Product
    Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB-C-8F, 4MM Carbide Fluted Ball, 10 Flutes - part # QD8-4B-C-10F 5MM Carbide Fluted Ball, 10 Flutes - part #QD8-5B-C-10F 7MM Carbide Fluted Ball, 14 Flutes - part #QD8-7B-C-14F Anspach…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0743-2014·2014-01-22

    Atrium Medical Recalls Chest Drain Tubing Due to Leak or Disconnect Risk

    Atrium Medical Corporation is recalling 1,944 units of Express Dry Seal ATS Chest Drains because the tubing may leak or disconnect.

    Product
    Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air Leak Monitor; Product Code: 4050-100P. To evacuate air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0723-2014·2014-01-22

    Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Issues

    Boston Scientific is recalling TWISTER PLUS 26mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.

    Product
    TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN):M00561421. Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica. Intended to be used in flexible endoscopes as a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0737-2014·2014-01-22

    Atrium Ocean Water Seal Chest Drain ATS Recall for Tubing Leaks

    Atrium Medical Corporation is recalling 6,684 Ocean Water Seal Chest Drain ATS units because the chest drain tubing may leak or disconnect.

    Product
    Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery System; Product Code: 2050-300. To evacuate air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    Distributed nationwide