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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23801–23825 of 27663

  • HighFDA (Devices)·Z-1046-2015·2015-02-11

    Radiometer ABL90 FLEX Analyzer Recall for Calibration Data Errors

    Radiometer America Inc. is recalling ABL90 FLEX analyzers because they may not use the most recent calibration data, potentially leading to biased patient results.

    Product
    ABL90 FLEX analyzer; Model number 393-090. 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-1055-2015·2015-02-11

    BD 10 mL Syringes Recalled Due to Improperly Seated Stopper

    Becton Dickinson is recalling 564,000 units of 10 mL syringes because the stopper is not properly seated in the syringe.

    Product
    BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40 mm), not for skin injection; Catalog #305064 BD 10 mL Syringe Luer-Lok Tip with BD…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1052-2015·2015-02-11

    Zimmer Recalls Persona Tibial Articular Surface Provisional Shims Due to Cleaning Defect

    Zimmer, Inc. is recalling Persona Tibial Articular Surface Provisional Shims because repeated sonic cleaning can break the ball bearing retention feature, potentially leaving parts in the surgical wound.

    Product
    Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04. Product Usage: The Persona TASPs are sterilizable instruments Intended for multiple uses. The TASP components are used to aid the surgeon in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1041-2015·2015-02-11

    Roche Cobas b 221 Blood Gas Analyzer Recalled for Measurement Bias

    Roche Diagnostics is recalling 103 Cobas b 221 analyzers because bacterial contamination causes inaccurate glucose and lactate readings.

    Product
    Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1053-2015·2015-02-11

    CareFusion Recalls SmartSite Infusion Sets Due to Disconnection and Leakage

    CareFusion is recalling 7,440 SmartSite Low Sorbing Infusion Sets due to disconnection and leakage issues.

    Product
    SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The set is comprised of components commonly found on intravascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1013-2015·2015-02-04

    Siemens Syngo RT Therapist Software Recall Due to Mistreatment Risk

    Siemens is recalling Syngo RT Therapist software because a combination with CTVision may cause wrong offset calculations, leading to patient mistreatment.

    Product
    Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1022-2015·2015-02-04

    Innokas Medical VC150 Vital Signs Monitor Recalled for Alarm Failure

    Innokas Medical is recalling 20 VC150 Vital Signs Monitors because they may fail to issue visual and audible alarms when SpO2 or RRa values violate limits during mode switching.

    Product
    VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1011-2015·2015-02-04

    Philips BrightView MRI Systems Recalled for Unintended Movement

    Philips is recalling 1,064 BrightView MRI systems worldwide due to software issues causing unintended detector and gantry movement.

    Product
    BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and 882454 Medical Device for imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1014-2015·2015-02-04

    Clinical Innovations Recalls Ebb Complete Tamponade System Due to Balloon Leak Risk

    Clinical Innovations, LLC is recalling 827 units of the Ebb Complete Tamponade System because of a potential for balloon leaks in lots manufactured since August 2014.

    Product
    Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1016-2015·2015-02-04

    Mobius Airo Mobile Intraoperative CT System Recalled for Data Transfer Errors

    Mobius Imaging is recalling 21 Airo Mobile Intraoperative CT systems because a software error may cause incorrect or missing navigation data to transfer to the Brainlab Curve system.

    Product
    Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1031-2015·2015-02-04

    Baxter HomeChoice Peritoneal Dialysis Cycler Recalled for Keypad Malfunction

    Baxter Healthcare is recalling HomeChoice and HomeChoice Pro automated peritoneal dialysis cyclers because the keypad buttons may activate without being pressed.

    Product
    HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-1020-2015·2015-02-04

    Sunrise Medical Recalls Six Quickie Q7 Adult Rigid Wheelchairs

    Sunrise Medical is recalling six Quickie Q7 Adult Rigid Wheelchairs because the height-adjustable handle may dislodge due to failing locking mechanisms.

    Product
    Quickie Q7 Adult Rigid Wheelchair Model EIR4.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0996-2015·2015-01-28

    TransMotion Medical Recalls Powered Stretcher Chairs Due to Involuntary Movement

    TransMotion Medical Inc is recalling 1,127 powered stretcher chairs used in surgeries because the controllers may cause the chairs to move involuntarily.

    Product
    Powered stretcher chair used during facial and eye surgeries. One chair per package.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1003-2015·2015-01-28

    Dick's Sporting Goods Recalls Fitness Gear Inversion Tables Due to Injury Reports

    Dick's Sporting Goods is recalling Fitness Gear Inversion Tables because customers reported falling and sustaining injuries. The products were distributed nationwide.

    Product
    Fitness Gear Inversion table (Style STE00059FG or Style STE00118FG), Distributed by ASLI, Wilmington, DE (on carton), Paradigm Health & Wellness, Inc. (in user manuals); The products are inversion tables, which allow the user to secure his or her ankles to the table and invert.…
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0993-2015·2015-01-28

    Maquet Tegris System Recalled Due to Software Error in Operating Table Commands

    Maquet Medical Systems USA is recalling six units of the Tegris System because a software error switches leg movement commands for the Magnus OR table.

    Product
    TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration System is designed to be used as the central operating unit in an operating room. The integration system has two main functions: Recording and distribution of images and videos and interaction…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0994-2015·2015-01-28

    Siemens Radiographic Systems Recalled for Potential Image Flipping Errors

    Siemens is recalling 11 Ysio Max, Luminos dRF Max, and Agile Max systems because software errors may cause images to flip, leading to incorrect labels and potential misdiagnosis.

    Product
    Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including…
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1000-2015·2015-01-28

    BD Biosciences Recalls Contaminated CD8 PE In Vitro Diagnostic Reagent

    BD Biosciences is recalling one lot of CD8 PE reagent contaminated with CD4 FITC, which may cause incorrect patient data.

    Product
    CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0998-2015·2015-01-28

    Cordis POWERFLEX PRO PTA Dilatation Catheter Recall for Unsterilized Unit

    Cordis Corporation is recalling one unsterilized unit of the POWERFLEX PRO PTA Dilatation Catheter from a demonstration lot left at a hospital.

    Product
    Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0995-2015·2015-01-28

    Ferno Model 35X Stretchers Recalled Due to Loose Wheel Assemblies

    Ferno-Washington Inc is recalling 46 Model 35X stretchers because wheel castor assemblies may loosen, posing a risk of injury.

    Product
    Ferno Model 35X PROFlexx Stretchers, one unit per package
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-0963-2015·2015-01-21

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Malfunction Risk

    Philips is recalling HeartStart MRx monitor/defibrillators because the device may malfunction, potentially delaying or disabling therapy or delivering it inadvertently.

    Product
    HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0916-2015·2015-01-21

    Boston Scientific Recalls Lotus TAVR Valve Prosthesis Due to Unlocking Risk

    Boston Scientific is recalling Lotus TAVR 25mm valve prostheses because the valve may unlock during release, potentially requiring additional procedures or surgery.

    Product
    Lotus TAVR 25mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV250, Catalog Number LTV25; Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0980-2015·2015-01-21

    Siemens Linear Accelerators Recalled for Unauthorized Component Safety Risks

    Siemens Medical Solutions is recalling 320 linear accelerators because unauthorized third-party components may cause patient or operator injury and dose calculation errors.

    Product
    Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON M2 6740, MEVATRON M2 6700, MEVATRON…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0951-2015·2015-01-21

    FDA Recalls Unapproved Color Contact Lenses Contaminated with Bacteria

    Intertrade Imports Inc. is recalling I Color Complete contact lenses because FDA testing found bacteria and the product is not sterile.

    Product
    Labeled in part: I Color Complete / Crazy Lens, blister packing, 14.5mm, (Additional colors include: #003 White out, #005 Yellow out, #020 Red out, #014 Black out, #070 Manson, #136 Lava, #009 Yellow cat, #073 Red cat, #050 White cat, #032 Soccer ball, #077 Spiral, #071…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0915-2015·2015-01-21

    Boston Scientific Recalls Lotus TAVR 23mm Transcatheter Aortic Valve Prosthesis

    Boston Scientific is recalling 278 units of the Lotus TAVR 23mm valve because the device may unlock during release, potentially causing the valve to embolize.

    Product
    Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV230, Catalog Number LTV23; Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific…
    Category
    Medical Device
    Distribution
    0 states