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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31751–31775 of 40449

  • ModerateFDA (Devices)·Z-0144-2016·2015-10-28

    ConFormis iTotal CR Knee Replacement System Recalled for Ethylene Glycol Residue

    ConforMIS, Inc. is recalling 3 units of the iTotal CR Knee Replacement System because they may contain small amounts of ethylene glycol residue.

    Product
    ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT Catalog Number: TCR1111111
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0150-2016·2015-10-28

    B. Braun Recalls Perifix Epidural Anesthesia Trays Due to Discoloration

    B. Braun Medical is recalling 433 Perifix Continuous Epidural Anesthesia Pain Control Trays because the DuraPrep solution may be discolored from unintended sterilant exposure.

    Product
    Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to provide regional anesthesia for pain management.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0146-2016·2015-10-28

    ConFormis iTotal CR Knee Replacement System Recalled for Ethylene Glycol Residue

    ConforMIS, Inc. is recalling 348 units of the iTotal CR Knee Replacement System because they may contain small amounts of ethylene glycol residue.

    Product
    ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M5725INT0600020 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0153-2016·2015-10-28

    OneTray Sealed Sterilization Containers Recalled for Incorrect Labeling

    Innovative Sterilization Technologies LLC is recalling OneTray Sealed Sterilization Containers because the labels list the wrong steam sterilization time.

    Product
    OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0149-2016·2015-10-28

    Natus neoBLUE 3 Phototherapy System Recalled for Intensity Documentation

    Natus Medical is recalling 4,560 neoBLUE 3 Phototherapy systems because the instruction manuals did not accurately reflect the cleared intensity settings.

    Product
    Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number: 001103
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0136-2016·2015-10-28

    Biomet Neuro Combo Set Case Lid Requiring Excessive Force Recalled

    Biomet Microfixation is recalling 37 Neuro Combo Set Cases because the lids require excessive force to open.

    Product
    Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0135-2016·2015-10-28

    Philips MRI Systems Recalled for Incorrect Cross-Reference Lines in Spine Imaging

    Philips Medical Systems is recalling specific MRI systems due to a software defect that may cause cross-reference lines to be positioned incorrectly in spine clinical workflows.

    Product
    All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software. Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the…
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Devices)·Z-0140-2016·2015-10-28

    ConForMIS iUNI Knee Replacement Recalled for Ethylene Glycol Residue

    ConForMIS is recalling 6 units of the iUNI Unicondylar Knee Replacement System due to potential ethylene glycol residue.

    Product
    ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral Catalog Number: M57220600240 (US) M5722INT0600240 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0139-2016·2015-10-28

    ConForMIS Knee Replacement System Recalled for Ethylene Glycol Residue

    ConforMIS, Inc. is recalling 71 units of the ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial due to potential small amounts of ethylene glycol residue.

    Product
    ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial Catalog Number: M57220600210(US) M5722INT0600210 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0125-2016·2015-10-21

    Synthes Recalls Titanium Elastic Nail Inserters Due to Mechanical Failure Risk

    Synthes (USA) Products LLC is recalling 1,550 Inserter for Titanium Elastic Nails (TEN) devices due to a potential for mechanical failures such as breakage.

    Product
    Inserter for Titanium Elastic Nails (TEN), orthopedic device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0115-2016·2015-10-21

    ViewRay MRIdian Radiation Therapy System Recalled for Unexpected Couch Movement

    ViewRay is recalling four MRIdian Radiation Therapy Systems because the patient couch may move unexpectedly if an encoder fails and the system is restarted.

    Product
    MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0119-2016·2015-10-21

    Zimmer Natural Nail CM Long Intramedullary Fixation Rods Recalled for Packaging Defects

    Zimmer GmbH is recalling 57,603 units of Natural Nail CM Long intramedullary fixation rods because compromised outer trays may lead to periprosthetic infection.

    Product
    Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0121-2016·2015-10-21

    DJO Monode Shortwave Accessory Recalled for Overheating and Burning Insulation

    DJO, LLC is recalling Monode Shortwave Accessories due to overheating and burning of the wire insulation inside the applicator.

    Product
    Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave Diathermy 100 and Intelect Shortwave Diathermy 400 units. For the clinical application of electromagnetic energy in the radio frequency of 27.12 megahertz to generate deep heat…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0123-2016·2015-10-21

    Clinical Innovations Recalls Ebb Complete Tamponade System Due to Balloon Leak Risk

    Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System due to a potential balloon leak that may prevent the device from delivering therapy when needed.

    Product
    The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0120-2016·2015-10-21

    Ev3 Neurovascular Recalls Pipeline Embolization Devices Due to Incorrect Instructions

    Micro Therapeutics Inc, dba Ev3 Neurovascular, is recalling 23 Pipeline and Pipeline Flex Embolization Devices because they were shipped with EU-version Instructions for Use.

    Product
    -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based delivery system. The Pipeline and Pipeline Flex embolization device implant is a braided…
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0124-2016·2015-10-21

    Synthes Humerus Plates Recalled for Incorrect Part Number Labeling

    Synthes (USA) Products LLC is recalling 36 units of VA-LCP Humerus Plates because one part number was incorrectly etched on the device.

    Product
    Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile The Synthes 2.7 mm/3.5 mm Variable Angle LCP Elbow System is intended for fixation of fractures of the…
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0017-2016·2015-10-21

    Toshiba Aquilion CT System Recall for Data Loss Risk

    Toshiba is recalling 459 Aquilion CT Systems because specific scanning operations may prevent raw data from being saved.

    Product
    Toshiba Aquilion CT System TSX-302A
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0015-2016·2015-10-21

    Toshiba Aquilion CT System Recalled for Data Loss Risk

    Toshiba American Medical Systems is recalling 459 Aquilion CT Systems because specific scanning operations may cause raw data to not be saved.

    Product
    Toshiba Aquilion CT System TSX-301B
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0013-2016·2015-10-21

    Toshiba Aquilion CT System Recall for Data Loss Risk

    Toshiba is recalling 459 Aquilion CT Systems because specific multi-phase scanning operations may prevent raw data from being saved.

    Product
    Toshiba Aquilion CT System TSX-101A
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0127-2016·2015-10-21

    Arrow International Recalls PICC Catheters Due to Labeling Inaccuracy

    Arrow International Inc is recalling 4FR Single Lumen Pressure Injectable PICC catheters because the instructions state they withstand 10 pressure injections, but they are only tested for 5.

    Product
    4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0126-2016·2015-10-21

    Synthes Screw Inserter Recalled for Incorrect Etched Graphics

    Synthes (USA) Products LLC is recalling 793 units of the Screw Inserter because the etched graphics may not correspond to the instrument's actual angle.

    Product
    Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head element insertion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0016-2016·2015-10-21

    Toshiba Aquilion CT System Recall for Potential Data Loss

    Toshiba is recalling 459 Aquilion CT Systems because specific multi-phase scanning operations may prevent raw data from being saved.

    Product
    Toshiba Aquilion CT System TSX-301C
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0122-2016·2015-10-21

    Alere Cholestech LDX Multianalyte Controls Recalled for Incorrect Ranges

    Alere San Diego is recalling Cholestech LDX Multianalyte Controls because the assigned control ranges for Total Cholesterol and Triglycerides are incorrect.

    Product
    Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG) and glucose (GLU) test procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0117-2016·2015-10-21

    Natus Neurology Recalls NicoletOne Software Due to Signal Obstruction

    Natus Neurology is recalling NicoletOne Software v5.94 because a persistent impedance check signal obscures EEG data, potentially affecting clinical monitoring.

    Product
    NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review system, either with or without synchronous digital video. The system is intended for medical purposes to record, measure, store and display full band (FbEEG) cerebral EEG and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0018-2016·2015-10-21

    Toshiba Aquilion CT System Recall for Data Loss Risk

    Toshiba is recalling 459 Aquilion CT Systems because specific multi-phase scanning operations may cause acquired raw data to not be saved.

    Product
    Toshiba Aquilion CT System TSX-303A
    Category
    Medical Device
    Distribution
    1 state