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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33701–33725 of 40449

  • 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
  • ModerateFDA (Devices)·Z-0997-2015·2015-01-28

    Philips IntelliVue TcG10 Monitor Recalled for Missing Contraindication Warning

    Philips is recalling 86 IntelliVue TcG10 monitors because the instructions for use are missing a warning against using the device on patients under gas anesthesia.

    Product
    Philips IntelliVue TcG10; Monitor, carbon-dioxide, cutaneous. The IntelliVue TcG10 is a device for the measurement of the transcutaneous O2 and CO2 partial pressure in neonates, pediatrics and adults.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1002-2015·2015-01-28

    BD Biosciences Recalls Contaminated Anti-Lambda APC-H7 Antibody Lots

    BD Biosciences is recalling two lots of Anti-Lambda APC-H7 antibody due to contamination with CD38 antibody. The product is used for in vitro flow cytometric immunophenotyping.

    Product
    Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1007-2015·2015-01-28

    Arrow Hemodialysis Catheterization Sets Recalled for Tunneling Sheath Cracking

    Arrow International is recalling specific hemodialysis catheterization sets because the tunneling sheath can crack during placement, potentially delaying treatment.

    Product
    The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access, part numbers: AC-15192-SFX, AC-15232-SFX, AC-15272-SFX, AC-15312-SFX, AC-15422-SFX, CS-15192-SFX, CS-15192-SFXM, CS-15232-SFX, CS-15242-I…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0999-2015·2015-01-28

    Roche Recalls cobas 4800 KRAS Mutation Test Kits for Invalid Results

    Roche Molecular Systems is recalling cobas 4800 KRAS Mutation Test kits because they are generating invalid results for the Mutant Control and/or KRAS Calibrator.

    Product
    cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of mutations in codons 12,13 and 61 of the KRAS Gene in DNA derived from formalin-fixed paraffin-embedded human colorectal and non-small cell lung cancer tissues.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1001-2015·2015-01-28

    Genetic Testing Institute Recalls PF4 Concentrated Wash Reagent Lots

    Genetic Testing Institute is recalling specific lots of PF4 Concentrated Wash (10x) because the reagent is slightly more dilute than intended, which may cause false positive test results.

    Product
    PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13G, HAT45G) and 2. ImmucorGamma LIFECODES PF4 Enhanced (catalog numbers X-HAT13, X-HAT45) The PF4 IgG assay is an Enzyme Linked…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1005-2015·2015-01-28

    Arrow International Recalls Multi-Lumen CVC Kits Due to Missing Instructions

    Arrow International Inc is recalling 420 Multi-Lumen PI CVC Kits and PSI Kits because the Instructions for Use were inadvertently removed from the packaging.

    Product
    Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015: Product Usage: Multi-Lumen PI CVC Kit: An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-1006-2015·2015-01-28

    Aptalis Flutter Percussor Respiratory Device Recalled for Packaging Defect

    Aptalis Pharmatech Inc. is recalling approximately 49,000 Flutter Percussor respiratory devices because the packaging may be difficult to open or close.

    Product
    FLUTTER Percussor respiratory device, packaged one unit per clear plastic package. Product Usage: Product is a percussor device, intended to be used as a mucus clearance device for patients with mucus producing respiratory conditions such as: atelectasis, bronchitis…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1004-2015·2015-01-28

    Ortho-Clinical VITROS Software Recall Due to Calibration Failure

    Ortho-Clinical Diagnostics is recalling VITROS Software Version 3.1 because calibration may not occur when using specific calibrator barcode labels.

    Product
    VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integrated System 1) VITROS 4600 - in vitro quantitative measurement of a variety of analytes, 2) VITROS 5600 - in vitro quantitative…
    Category
    Medical Device
    Distribution
    7 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
  • SevereFDA (Devices)·Z-0917-2015·2015-01-21

    Boston Scientific Recalls Lotus TAVR 27mm Transcatheter Aortic Valve Prosthesis

    Boston Scientific is recalling 278 units of the Lotus TAVR 27mm valve because the device may unlock during release, potentially causing the valve to embolize.

    Product
    Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV270, Catalog Number LTV27; 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-0953-2015·2015-01-21

    DePuy ATTUNE INTUITION Impaction Handle Recalled for Fracture Risk

    DePuy Orthopaedics is recalling ATTUNE INTUITION Impaction Handles because the lever can fracture during knee surgery, potentially leaving device pieces in the patient.

    Product
    The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The instrument interfaces with several related ATTUNE instruments: keel punch, tibial tower, evaluation bullet, fixed bearing tibial impactor, rotating platform tibial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0954-2015·2015-01-21

    GE Healthcare Proteus XR/a Wall Stand Cable Breakage Recall

    GE Healthcare is recalling Proteus XR/a X-ray systems with wall stands due to potential breakage of steel support cables. No injuries have been reported.

    Product
    GE Healthcare, Proteus XR/a with wall stand model number 600-0301.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0956-2015·2015-01-21

    Brainlab iPlan RT Dose Software Recalled for Potential Positioning Errors

    Brainlab AG is recalling iPlan RT Dose software because it may produce incorrect patient positioning when using multiple CT image data sets.

    Product
    iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0948-2015·2015-01-21

    Abbott m2000sp Automated Sample Preparation System Recalled for X-Drive Failure

    Abbott Molecular is recalling 176 m2000sp automated sample preparation systems because the x-drive assembly may fail prematurely, potentially causing the manipulator arm to contact objects or pipet improperly.

    Product
    The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.
    Category
    Medical Device
    Distribution
    12 states