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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Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

38776–38800 of 40449

  • HighFDA (Devices)·Z-0952-2013·2013-03-27

    Extremity Medical Recalls Undersized 1.6 mm Orthopedic Guidewires

    Extremity Medical LLC is recalling 238 non-sterile 1.6 mm guidewires because they are undersized, causing depth gauge readings to select screws approximately 2 mm longer than intended.

    Product
    Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile. Contained in Extremity Medical Surgical Kits including CompressX, Hallu.X, IO Fix and XMCP. Used in the selection of screw size when used with…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0963-2013·2013-03-27

    DePuy Spine Recalls CONFIDENCE Spinal Cement System Kits

    DePuy Spine is recalling CONFIDENCE Spinal Cement System Kits because the cement mixer may not turn properly and could jam or get stuck during surgery.

    Product
    DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0972-2013·2013-03-27

    DePuy ReClaim Reamer Extension Recalled Due to Broken Tabs

    DePuy Orthopaedics is recalling 750 ReClaim Reamer Extension devices because tabs may break and remain in patients during surgery.

    Product
    ReClaim Reamer Extension; Product code 2975-00-500, used with Reclaim Modular Revision Hip Prosthesis System. The ReClaim Reamer Extension is as an attachment to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0962-2013·2013-03-27

    DePuy Spine Recalls Cement Mixer Kits Due to Jamming Risk

    DePuy Spine is recalling CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus kits because the cement mixer may jam or fail to turn properly during surgery.

    Product
    DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0959-2013·2013-03-27

    Allen Medical Systems Recalls Traction Boots Due to Assembly Defect

    Allen Medical Systems is recalling 24 traction boots because incorrect assembly could cause the boot to detach, allowing a patient's leg to fall during surgery.

    Product
    Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders, non-invasive medical devices designed to attach to orthopedic fracture tables to aid clinical staff in applying traction to the leg of a patient during surgical…
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0954-2013·2013-03-27

    Biomet Spine Polaris Screw Inserter Recalled for Tip Failure Risk

    Ebi, LLC is recalling 59 units of the Biomet Spine Polaris 5.5 Button Lock Screw Inserter due to an increased risk of failure at the driver tip during use.

    Product
    Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0960-2013·2013-03-27

    DePuy Confidence Spinal Cement Mixer Recall for Jamming Defect

    DePuy Spine is recalling the Confidence Spinal Cement System 5cc Kit because the cement mixer may not turn properly and may jam or get stuck during surgery.

    Product
    DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0969-2013·2013-03-27

    Molded Products Recalls Sterile Hemodialysis Line Sets Due to Leaks

    Molded Products Inc is recalling 1,200 sterile access and return line sets used in hemodialysis because they leak at the connection site.

    Product
    Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0973-2013·2013-03-27

    Keystone Dental Recalls Mislabeled PrimaConnex Tapered Dental Implants

    Keystone Dental Inc is recalling 120 units of PrimaConnex Tapered Implants because the included cover screw was a WD type instead of the labeled SD type.

    Product
    PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0964-2013·2013-03-27

    Stryker Specialty Triathlon Knee Sizer Adjustment Housing Recalled for Fit and Marking Errors

    Stryker is recalling four units of Specialty Triathlon Knee Sizer Adjustment Housings because the standard femoral stylus does not fit and the left/right markings on the right sizer are reversed.

    Product
    Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use in knee prosthesis implantation. NON-STERILE
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0956-2013·2013-03-27

    Synthes Recalls Four Mis-etched Variable Angle Locking Compression Plates

    Synthes USA is recalling four Variable Angle Locking Compression Plates that were incorrectly etched with the wrong part number.

    Product
    Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Corrective osteotomies after distal radius malunion.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0958-2013·2013-03-27

    Beckman Coulter Recalls Creatinine Reagents for Calibration Instructions

    Beckman Coulter is recalling Creatinine reagents to provide updated instructions for calibration stability and quality control frequency.

    Product
    Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of Creatinine in human serum and urine on Beckman Coulter AU analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0967-2013·2013-03-27

    Alphatec ILLICO Spinal Rods Recalled for Incorrect Length Marking

    Alphatec Spine is recalling 7 ILLICO spinal rods that were laser-etched as 110mm but are actually 100mm long.

    Product
    ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine, Inc. The ILLICO¿ MIS Posterior Spinal Fixation System is intended to facilitate the surgical correction of non-cervical spinal deformities by providing temporary internal…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0957-2013·2013-03-27

    Siemens Tacrolimus Reagent Cartridge Recalled for Low Sample Recovery

    Siemens is recalling 2,976 Dimension Tacrolimus Flex reagent cartridges due to confirmed low patient sample recovery and a 25% low bias compared to LC/MS.

    Product
    Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.
    Category
    Medical Device
    Distribution
    20 states
  • LowFDA (Devices)·Z-0974-2013·2013-03-27

    Intio ClearStart-SVM User Manual Recalled for Editing Mistake

    Intio Inc. is recalling seven copies of the ClearStart-SVM User Manual due to an editing mistake that could be interpreted as promoting an unapproved use.

    Product
    INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual. Part #: UM-06-20-0003. ClearStart-SVM is used for patient assessment using CT (computed tomography) images, in order to plan potential therapies or monitor tumor response to treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0970-2013·2013-03-27

    Agfa X-Ray Image Plate Recall Due to Incorrect Barcode Labeling

    Agfa Corp. is recalling 17 X-ray image plates shipped with incorrect size barcodes, affecting facilities in 10 US states.

    Product
    CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in an X-Ray cassette, used to capture images from X-Ray exposures. The cassette with the image plate, once exposed, is inserted in the Agfa Digitizer CR 10-X where the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0966-2013·2013-03-27

    Volk Optical Recalls 20 Diopter Binocular Indirect Ophthalmoscope Lenses

    Volk Optical Inc is recalling 40 units of 20 Diopter Binocular Indirect Ophthalmoscope lenses due to mixed-up lot number engravings on the devices and packaging.

    Product
    20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0945-2013·2013-03-20

    Philips CT Systems Recalled for Patient Table Brake Malfunction

    Philips is recalling 4,797 CT systems because a vertical brake malfunction caused an unexpected downward movement of the patient table.

    Product
    Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v. EXP are Computed Tomography X-Ray Systems. These devices are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0940-2013·2013-03-20

    Symbios GOPump Elastometric Infusion PumpKit Recalled for Flow Restrictor Displacement

    Symbios Medical Products is recalling 458 GOPump Elastometric Infusion PumpKits because a flow restrictor bead may become displaced, permitting fast flow of contents.

    Product
    GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump, part number 510076: One infusion pump comprising two, 150 mL elastomeric reservoirs, each of which connects to its own catheter. Liquid flow rate is labeled at 2 mL/hr per elastomer.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0928-2013·2013-03-20

    Sorin Isoline Implantable Defibrillation Leads Recalled for Insulation Breach

    Sorin Group USA is recalling 1,376 Isoline implantable defibrillation leads due to potential internal insulation breaches. The leads are used for treating life-threatening heart arrhythmias.

    Product
    Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0939-2013·2013-03-20

    Draeger Infinity Acute Care System Recall for Inaccurate Blood Pressure Readings

    Draeger Medical is recalling 260 Infinity Acute Care System monitoring units because liquid ingress in the cable can cause inaccurate invasive blood pressure measurements.

    Product
    Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0934-2013·2013-03-20

    GE Healthcare Recalls Cardiovascular X-ray Systems Due to Exposed Wires

    GE Healthcare is recalling 48 Innova IQ cardiovascular X-ray systems because exposed high-voltage wires inside the cabinet pose a shock hazard.

    Product
    GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imaging systems. For use in generating fluoroscopic images of human anatomy.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0931-2013·2013-03-20

    Elekta Synergy XVI Radiation Therapy Imager Recalled for DICOM Tag Defect

    Elekta, Inc. is recalling 164 Synergy XVI Radiation Therapy Digital Imagers because DICOM tags lack sufficient information to identify volumes with the same name.

    Product
    Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0946-2013·2013-03-20

    Natus Neurology Recalls Nicolet EEG Wireless Amplifiers Due to Overheating Risk

    Natus Neurology is recalling 114 Nicolet EEG Wireless Amplifiers because they may overheat near the on/off button, posing a risk of discomfort or burns.

    Product
    Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel amplifier and 515-015500 for the 64 channel amplifier. Product Usage: The Nicolet Wireless EEG Amplifier is intended to be used as a front end amplifier to acquire, store, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0949-2013·2013-03-20

    Hill-Rom TotalCare SpO2RT2 Bed Recalled for Software Pressure Issue

    Hill-Rom is recalling 309 TotalCare SpO2RT2 beds due to a software defect that may reduce surface cushion pressure, potentially increasing the risk of skin irritation for high-risk patients.

    Product
    TotalCare SpO2RT2 bed. Product Usage: Bed, flotation therapy, powered bed may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia…
    Category
    Medical Device
    Distribution
    Distributed nationwide