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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31826–31850 of 40325

  • ModerateFDA (Devices)·Z-2808-2015·2015-09-30

    Bard Access Systems Recalls PowerPICC Catheter Marketing Brochures

    Bard Access Systems is recalling 1,811 marketing brochures for PowerPICC and PowerPICC SOLO catheters because they contain incorrect indications for use.

    Product
    Marketing brochures for the PowerPICC and PowerPICC SOLO catheters
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2800-2015·2015-09-30

    Zien Medical PenBlade Safety Scalpel Recalled for Sterile Barrier Risk

    Zien Medical Technologies is recalling PenBlade Safety Scalpels because cracks in the PET trays may compromise the sterile barrier.

    Product
    PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-M-11P, PB-M-15
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2815-2015·2015-09-30

    Siemens RAPIDPoint 500 Lactate Cartridges Recalled for Sodium Bias

    Siemens is recalling 982 RAPIDPoint 500 Lactate cartridges due to a negative sodium bias that affects quality control and patient results.

    Product
    Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests Part Number: 10491447 Product Usage: 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2806-2015·2015-09-30

    Fujifilm EPX 2500 Processor Manual and Brochure Recall

    Fujifilm is recalling EPX 2500 Processor manuals and brochures that incorrectly identify the ED-530XT endoscope's image quality.

    Product
    Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2817-2015·2015-09-30

    BD Biosciences Recalls CD4 FITC Reagent Due to Spanish Labeling Error

    Becton, Dickinson and Company is recalling 128 units of CD4 (SK3), FITC reagent because the Spanish text on the label incorrectly identifies the product as CD8 FITC.

    Product
    CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in Hematology: The SK3 monoclonal antibody reacts with human CD4, a 59-kDa cell surface receptor expressed by a majority of thymocytes, a subpopulation of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2810-2015·2015-09-30

    Stryker Recalls Trident Hip Implant Components Due to Documentation Error

    Stryker Howmedica Osteonics is recalling 16 units of Trident hip implant inserts due to a documentation issue, despite the parts meeting all device specifications.

    Product
    Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-2731-2015·2015-09-23

    SynCardia Recalls Freedom Drivers for Potential Drive Mechanism Failure

    SynCardia Systems is recalling Freedom Drivers because a component may fail, causing the drive mechanism to stop pumping and resulting in the loss of life-sustaining function.

    Product
    Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2770-2015·2015-09-23

    Lumenis VersaCut+ Tissue Morcellator Hand Pieces Recalled for Unpredictable Operation

    Lumenis is recalling VersaCut+ Tissue Morcellator hand pieces because they may operate unpredictably during surgery, potentially damaging non-target tissue.

    Product
    Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and…
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2769-2015·2015-09-23

    Applied Medical Resources Recalls Voyant Open Fusion Devices

    Applied Medical Resources Corp is recalling Voyant Open Fusion Devices due to a potential risk of improper tissue characterization, which may result in nonoptimal power delivery.

    Product
    Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant Open Fusion Device is designed for use with the Voyant Electrosurgical Generator. The device is an advanced bipolar instrument that uses RF energy, provided by the generator, to seal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2762-2015·2015-09-23

    Revmedx Recalls XGAUZE Trauma Dressings Due to Potential Package Integrity Issues

    Revmedx Inc is recalling XGAUZE Trauma Dressings because shipping containers may have caused small tears or pinholes in the packaging, potentially rendering the sterile devices unsterile.

    Product
    XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cellulose sponges. Upon contact with blood or exudate, the sponges expand, thus increasing the dressing's capacity to absorb fluids.…
    Category
    Medical Device
    Distribution
    5 states
  • 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