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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31926–31950 of 40449

  • HighFDA (Devices)·Z-2777-2015·2015-09-23

    Medtronic CryoConsole Recalled Due to USB Component Issue

    Medtronic is recalling 103 CryoConsole units because a USB memory component issue can result in extended procedure time during cardiac ablation.

    Product
    Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2767-2015·2015-09-23

    Nico Myriad Console Recalled for Potential Cable Malfunction

    Nico Corp. is recalling six Myriad Console units because twisted cables may cause wire breaks or shorts, leading to unexpected aspiration increases during surgery.

    Product
    NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for morcellation of soft tissue. It primarily consists of a reusable console with foot pedal and a disposable handpiece. For the morcellation and removal of tissue…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2761-2015·2015-09-23

    Medivators Recalls Hemocor HPH700 Hemoconcentrators Due to Low Ultrafiltration Performance

    Medivators, Inc. is recalling 840 Hemocor HPH700 Hemoconcentrators because they may exhibit low ultrafiltration performance below product specifications.

    Product
    Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2771-2015·2015-09-23

    Sony Medical Monitors Recalled for Failure to Power On or Display Image

    Sony Medical Systems is recalling 4,952 medical monitors that may fail to turn on or lose image during clinical use.

    Product
    Sony LMD-1951MD, Sony LMD1951MD/BS, Sony LMD-1951MC (Foreign) 19 inch medical grade liquid crystal display (LCD) Medical Monitors with light-emitting diode (LED) backlight technology.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2775-2015·2015-09-23

    Bayer Medrad Mark 7 Arterion Injection System Software Recall

    Bayer Healthcare is recalling 71 Medrad Mark 7 Arterion Injection Systems due to a software defect that removes purge enforcement, potentially affecting angiographic studies.

    Product
    Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2772-2015·2015-09-23

    Stryker Orthobiologics Recalls Aliquot Delivery Kits Due to Packaging Defects

    Stryker Orthobiologics is recalling 9,805 Aliquot Delivery Kits because two instances of holes were found in the sterile packaging, which could compromise sterility.

    Product
    Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2782-2015·2015-09-23

    Intuitive Surgical Recalls Fluorescence Imaging Kits Due to Packaging Damage

    Intuitive Surgical is recalling 1,200 Fluorescence Imaging Procedure Kits because shipping damage may have compromised the sterile packaging of the stopcocks.

    Product
    Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers: 950156-01, 950156-02, 950156-03. Product Usage: General and plastic surgery: The da Vinci Firefly Imaging system is intended to provide real-time endoscopic visible and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2784-2015·2015-09-23

    St Jude Merlin@home Transmitter Recalled for Backup VVI Operation

    St Jude Medical is recalling Merlin@home RF Remote Monitoring Transmitters because some devices exhibit backup VVI operation due to a backup reset.

    Product
    Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2766-2015·2015-09-23

    Boston Scientific Recalls WATCHMAN Access Sheath Due to Valve Cross-Thread Risk

    Boston Scientific is recalling WATCHMAN Access System sheaths because the hemostasis valve may cross-thread if tightened with the dilator in place, potentially preventing the valve from sealing.

    Product
    Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F Single curve( M635TU10060, TU1006) , 14F Double curve (M635TU20060, TU2006) , & 14F Anterior curve (M635TU40060, TU4006). For cardiac use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2781-2015·2015-09-23

    Salter Labs NebuTech Nebulizers Recalled for Loose Inspiratory Valve Cap

    Salter Labs is recalling specific NebuTech nebulizer models because the inspiratory valve cap may detach during treatment.

    Product
    NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aerosols delivered directly to the patient for breathing. Designed to be used in either a hospital or homecare environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2778-2015·2015-09-23

    Fujifilm Medical Endoscope Manuals Recalled Due to Suction Button Defect

    Fujifilm Medical Systems U.S.A., Inc. is recalling 256 endoscope operation manuals because the suction button may become stuck after using x-ray contrast agents.

    Product
    Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2783-2015·2015-09-23

    Siemens ACUSON SC2000 Ultrasound System Recalled for Data Capture Error

    Siemens is recalling ACUSON SC2000 ultrasound systems because a software error prevents the capture of images or clips when patient names are registered with different capitalization.

    Product
    ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2765-2015·2015-09-23

    Boston Scientific WATCHMAN Device Field Correction for Hemostasis Valve Cross-Thread Risk

    Boston Scientific is issuing a field correction for WATCHMAN Left Atrial Appendage Closure Devices to prevent hemostasis valve cross-threading and potential blood leakage.

    Product
    Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System, 21mm x 12F ( M635WU21060, WU21060, 24mm x 12F(M635WU24060, WU2406) , 27mm x 12F(M635WU27060, WU2706) , 30mm x 12F(M635WU30060, WU3006) , 33mm x 12F( M635WU33060, WU3306). For cardiac use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2763-2015·2015-09-23

    Med Tec Recalls CIVCO Shoulder Retractors Due to Excessive Strap Length

    Med Tec Inc is recalling CIVCO Shoulder Retractors because the wrist straps used for patient positioning are too long.

    Product
    CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX. For use in patient positioning. The grips are used for pulling down the shoulders during radiotherapy simulation and treatment sessions where opposed lateral fields are used in…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2768-2015·2015-09-23

    MedTest DX Control Reconstitution Fluid Recalled for Fill Volume Variation

    MedtestDx, Inc. is recalling 79 kits of MedTest DX Control Reconstitution Fluid due to vial fill volume variations that may cause control results to fall outside suggested ranges.

    Product
    MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal plug seal rubber HC-DIL (Human Control Diluent) is reagent grade water filled into 5ml vials used to reconstitute Human controls HNC200 and HEC200. in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2774-2015·2015-09-23

    Advanced Sterilization Products Recalls CIDEX OPA Solution for Rinsing Labeling

    Advanced Sterilization Products is reminding customers to follow rinsing instructions for CIDEX OPA Solution to ensure proper disinfection of medical devices.

    Product
    CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2760-2015·2015-09-23

    Biomet 3i Recalls Mislabelled UCLA Dental Abutment Cylinders

    Biomet 3i is recalling 61 UCLA Abutment Hexed Castable Cylinders because they were mislabeled as a different model. The error affects one specific lot distributed worldwide.

    Product
    UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2785-2015·2015-09-23

    RayStation Radiation Therapy Software Recalled for Display Errors

    RaySearch Laboratories is recalling RayStation software due to a floating-point precision error that affects the display of isodose lines and color tables.

    Product
    Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2776-2015·2015-09-23

    Edwards Pressure Monitoring Kit Recalled for Flow Restriction Issues

    Edwards Lifesciences is recalling pressure monitoring kits due to flow restriction in the IV set, which may prevent system priming or line flushing.

    Product
    Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2764-2015·2015-09-23

    Pointe Scientific autoHDL Reagent Recalled Due to Potential Crystals

    Pointe Scientific is recalling autoHDL Reagent H7545 because crystals may be present in the R1 reagent, potentially resulting from freezing during transport.

    Product
    Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2 HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2 Kits…
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Devices)·Z-2779-2015·2015-09-23

    Leica ASP200S/ASP300S Tissue Processor Recall for Wiring Defect

    Leica Microsystems is recalling 901 tissue processors due to incorrect internal wiring that may prevent remote alarms from functioning during instrument failure.

    Product
    The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.
    Category
    Medical Device
    Distribution
    31 states
  • LowFDA (Devices)·Z-2773-2015·2015-09-23

    Pointe Scientific Creatinine Reagent Recall Due to Labeling Error

    Pointe Scientific is recalling 93 kits of Creatinine Reagent C7539-150 because the R1 and R2 reagent bottles are mislabeled, which prevents valid test results.

    Product
    Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R1: HDPE plastic bottle. 120 ml fill. R2: HDPE plastic bottle. 90 ml fill.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2485-2015·2015-09-16

    Insulet Recalls OmniPod Insulin Devices Due to Deployment Failures

    Insulet Corporation is recalling specific OmniPod insulin devices because they may fail to deploy or retract the cannula, potentially disrupting insulin delivery.

    Product
    OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): 14810 (OUS). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2754-2015·2015-09-16

    Intuitive Surgical Recalls da Vinci Si Single-Site Fundus Graspers

    Intuitive Surgical is recalling 6,309 Fundus Graspers used with the da Vinci Si Surgical System because the jaws may become fixed in a closed position.

    Product
    Fundus Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428058-12, 428058-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2484-2015·2015-09-16

    Insulet Recalls OmniPod Insulin Devices Due to Cannula Deployment Failures

    Insulet Corporation is recalling specific OmniPod insulin devices because the cannula may fail to deploy or retract, potentially interrupting insulin delivery.

    Product
    OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): POD-ZXP420 (US). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
    Category
    Medical Device
    Distribution
    Distributed nationwide