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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25926–25950 of 27722

  • HighFDA (Devices)·Z-0112-2014·2013-11-06

    Fujinon Ultrasonic Endoscope Recall for Missing Set Screws

    Fujinon Inc is recalling 12 ultrasonic endoscopes due to missing set screws that secure the biopsy inlet port.

    Product
    Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0106-2014·2013-11-06

    Siemens RAPIDLab Blood Gas Analyzer Recall for Patient ID Error Risk

    Siemens is recalling RAPIDLab 1245 blood gas analyzers because users may enter wrong patient IDs, potentially leading to sample misidentification.

    Product
    Siemens RAPIDLab¿ 1245 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0126-2014·2013-11-06

    Carestream DRX-Revolution Mobile X-ray System Recalled for Sparking Power Plug

    Carestream Health is recalling 180 DRX-Revolution Mobile X-ray Systems because the power plug generates sparks and becomes warm to the touch.

    Product
    Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0088-2014·2013-11-06

    Intuitive Surgical Recalls da Vinci Si Surgical Systems Due to Mounting Risk

    Intuitive Surgical is recalling 1,090 da Vinci Si Surgical Systems because improper restraints during transport could cause the monitor to become loose from its mount.

    Product
    da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer. Intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0092-2014·2013-11-06

    Stryker TPS Micro Driver Recalled for Silicone Potting Defect

    Stryker is recalling 67 TPS Micro Drivers because silicone potting failed to cure properly, which could cause material leakage or electrical malfunction.

    Product
    REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance System Caution Federal Law (USA) restricts the device to use by or on the order of a physician Driver, Wire and Bone Drill; The Stryker Total Performance System (TPS) is intended for use in the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0122-2014·2013-11-06

    Toshiba Diagnostic Ultrasound Systems Recalled for Transducer Overheating

    Toshiba is recalling 430 diagnostic ultrasound systems because the transducer head may overheat under specific operating conditions.

    Product
    Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0104-2014·2013-11-06

    Siemens Blood Gas Analyzers Recalled for Patient Identification Error Risk

    Siemens is recalling RAPIDPoint and RAPIDLab blood gas analyzers because users may enter wrong patient IDs, leading to sample misidentification.

    Product
    Siemens RAPIDPoint¿ 500 system blood gas analyzer Product Usage: RAPIDPoint 500 System: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0109-2014·2013-11-06

    Baxter Recalls Vented Spike Adapters Due to Potential Pouch Tears

    Baxter Healthcare is recalling 49,344 units of Vented Spike Adapters because potential tears in the pouch could compromise sterility.

    Product
    Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. An IV transfer device, used to transfer fluids in pharmacy compounding system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0067-2014·2013-11-06

    Philips Ingenuity TF PET/CT Software Recall for Potential Radiopharmaceutical Re-injection Risk

    Philips is recalling 13 Ingenuity TF PET/CT systems due to software issues that could require patients to be re-injected with PET radiopharmaceuticals during rescans.

    Product
    Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) systems. The CT subsystem produces cross sectional images of the body by computer reconstruction of x-ray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0052-2014·2013-10-30

    Siemens Acuson SC2000 Ultrasound Systems Recalled for Inaccurate 3D Images

    Siemens is recalling 26 Acuson SC2000 ultrasound systems because a software issue causes inaccurate 3D images, which may lead to ablation in the wrong location.

    Product
    Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View, CA 94043 Medical Device for human use. Ultrasound imaging system used to measure anatomical structures and calculation packages that…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0048-2014·2013-10-30

    Abbott Medical Optics Recalls STAR Excimer Laser Systems Due to Component Failure

    Abbott Medical Optics is recalling STAR Excimer Laser Systems due to a thyristor component failure that affects the lamp and illumination system.

    Product
    STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0058-2014·2013-10-30

    Integra Licox Brain Tissue Oxygen Monitoring Kits Recalled for Defective Hex Wrench

    Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring Kits because some contain a hex wrench that may not loosen the set screw on the drill bit.

    Product
    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.SR Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0050-2014·2013-10-30

    Convergent Dental Recalls Five Solea 1.0 Laser Surgical Instruments

    Convergent Dental is recalling five Solea 1.0 laser surgical instruments due to a defect that could cause unintended laser emission during activation.

    Product
    Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0049-2014·2013-10-30

    Abbott STAR Excimer Laser Systems Recalled for Thyristor Component Failure

    Abbott Medical Optics is recalling STAR Excimer Laser Systems due to a thyristor failure on the AC Power Distribution PCB that affects the lamp and illumination system.

    Product
    STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Product is manufactured and distributed by AMO Manufacturing USA, LLC Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0055-2014·2013-10-30

    Integra Licox Brain Tissue Oxygen Monitoring Kits Recalled for Defective Hex Wrench

    Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring kits because a hex wrench may fail to loosen the set screw on the drill bit.

    Product
    Integra Licox Brain Tissue Oxygen Monitoring; 1 x Dual Lumen Introducer Kit REF IP2; Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0028-2014·2013-10-30

    Becton Dickinson Recalls BBL MGIT Mycobacteria Tubes Due to Barcode Error

    Becton Dickinson is recalling 187,000 BBL MGIT Mycobacteria Growth Indicator Tubes because incorrect barcodes may cause false negative test results.

    Product
    BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0047-2014·2013-10-30

    Abbott Recalls STAR Excimer Laser Systems Due to Power Component Failure

    Abbott Medical Optics is recalling STAR Excimer Laser Systems because a power component failure can cause the lamp and illumination system to malfunction.

    Product
    STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0060-2014·2013-10-30

    Integra Licox Brain Tissue Oxygen Monitoring Kit Recall for Hex Wrench Defect

    Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring Kits because a hex wrench may fail to loosen the set screw on the drill bit.

    Product
    Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2_EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0051-2014·2013-10-30

    Synergetics 25 Gauge Soft Tip Cannula Recall Due to Gauge Mislabeling

    Synergetics Inc is recalling 25 gauge Soft Tip Cannulas because some units are co-mingled with 23 gauge cannulas but labeled as 25 gauge.

    Product
    Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog number: 30.08.25. Single-use 25 gauge cannula used in vitreoretinal surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0045-2014·2013-10-30

    Merit Medical Recalls Performa Angiographic Catheters Due to Tip Shape Variation

    Merit Medical Systems is recalling 200 units of Performa Angiographic Catheters because four lots contain a catheter with a slight variation in tip shape.

    Product
    Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0034-2014·2013-10-30

    GE Healthcare Recalls Centricity Cardio Imaging 5.0 Software

    GE Healthcare is recalling Centricity Cardio Imaging 5.0 software due to a potential image labeling error in the Image Viewer that may affect diagnostic interpretation.

    Product
    Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose computing hardware. Centricity Cardio Imaging receives medical images and other…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0010-2014·2013-10-23

    GE Healthcare Recalls Ventilators and Anesthesia Machines with Unresponsive Buttons

    GE Healthcare is recalling 911 ventilators and anesthesia machines because manufacturing defects may cause display buttons to fail, preventing access to menu functions.

    Product
    GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0009-2014·2013-10-23

    GE Healthcare Recalls Anesthesia Devices Due to Tidal Volume Overdelivery Risk

    GE Healthcare is recalling specific anesthesia devices because they may deliver excessive tidal volume in a specific ventilation mode, posing a risk of harm to patients.

    Product
    GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0024-2014·2013-10-23

    GE PET Discovery 610 and 710 Recalled for Image Series UID Conflict

    GE Healthcare is recalling PET scanners because a software issue may cause different image series to share the same ID, potentially leading to incorrect image display.

    Product
    GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0025-2014·2013-10-23

    Boston Scientific COGNIS CRT-D Recall for Premature Battery Depletion

    Boston Scientific is recalling COGNIS CRT-D devices because a capacitor defect may cause premature battery depletion.

    Product
    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN…
    Category
    Medical Device
    Distribution
    Distributed nationwide