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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25551–25575 of 27722

  • 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-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-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
  • HighFDA (Devices)·Z-0740-2014·2014-01-22

    Atrium Oasis Chest Drain Tubing Recalled for Leak or Disconnect Risk

    Atrium Medical Corporation is recalling Oasis Dry Suction Water Seal ATS Chest Drains because the tubing may leak or disconnect.

    Product
    Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line connectors Product Code: 3650-100. To evacuate air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0742-2014·2014-01-22

    Atrium Express Dry Seal ATS Chest Drain Recalled for Leak or Disconnect Risk

    Atrium Medical Corporation is recalling 7,274 units of the Express Dry Seal ATS Chest Drain because the tubing may leak or disconnect.

    Product
    Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product Code: 4050-100N. To evacuate air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0747-2014·2014-01-22

    GE Healthcare Carescape Patient Data Module Recall for Latch Failure

    GE Healthcare is recalling Carescape Patient Data Modules due to a potential safety issue involving the intermittent failure of the spring-loaded mounting latch.

    Product
    GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0733-2014·2014-01-22

    Vital Diagnostics Recalls Eon Calcium Reagent Due to High Positive Bias

    Vital Diagnostics, Inc. is recalling 213 units of Eon Calcium Reagent because high positive calcium bias was observed in plasma samples compared to serum results.

    Product
    Consult Diagnostics¿ Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 For the quantitative measurement of calcium in plasma and serum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0710-2014·2014-01-22

    Boston Scientific Recalls Extractor Pro XL Retrieval Balloon Catheters

    Boston Scientific is recalling 39 units of Extractor Pro XL Retrieval Balloon Catheters due to potential incorrect skive hole location or balloon size.

    Product
    Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Balloon Catheter is used endoscopically to 1) remove stones from the biliary system; or 2) to facilitate injection of contrast medium while…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0720-2014·2014-01-22

    Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Integrity Issues

    Boston Scientific is recalling 425 TWISTER PLUS 22mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.

    Product
    TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN): M00561411. Distributed by: Boston Scientific. Manufactured by: Horizons International Corp. Intended to be used in flexible endoscopes as a retrieval device for foreign…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0741-2014·2014-01-22

    Atrium Oasis Chest Drain Tubing Recalled for Leak or Disconnect Risk

    Atrium Medical Corporation is recalling 954 units of Oasis Dry Suction Water Seal ATS Chest Drains because the tubing may leak or disconnect.

    Product
    Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain Dual patient lines; Product Code: 3652-100. To evacuate air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0722-2014·2014-01-22

    Boston Scientific Recalls Twister Plus Retrieval Devices Due to Seal Integrity Issues

    Boston Scientific is recalling 253 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 1 configuration) Universal Product Number (UPN):M00561420. 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