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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26001–26025 of 40233

  • ModerateFDA (Devices)·Z-3017-2017·2017-08-16

    Elekta Recalls iGUIDE Software 2.2 Due to Incorrect PEC Values

    Elekta, Inc. is recalling iGUIDE Software 2.2 because it contains incorrect PEC values. The software is used for patient positioning in radiotherapy environments.

    Product
    iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-2982-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS MIS Tapper 5.5mm Spinal Fixation Devices

    Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS MIS Tapper 5.5mm because the devices are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS MIS Tapper 5.5mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2995-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Rod Bender for Quality System Issues

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Rod Benders because they are not consistent with Quality System Requirements. The devices are used for spinal fixation.

    Product
    PALLAS M/MAXIMIS Rod Bender. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2969-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Rod Bender for Quality Issues

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Rod Benders because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Rod Bender. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2816-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection is recalling 54.2 million hypodermic needles because the company lacks sufficient documentation to support the products' sterility claims.

    Product
    Hypodermic Needle, 23 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2945-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 70mm Curved Rods

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 70mm Curved Rods due to non-compliance with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 70mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2779-2017·2017-08-09

    Myelotec Video Guided Catheters Recalled for Defective Access Port Body

    Myelotec, Inc. is recalling 2,980 Video Guided Catheters because a defective Access Port Body component can cause the port to become obstructed or blocked.

    Product
    Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2791-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes, creating a risk of sterile barrier breach.

    Product
    STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2796-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes that compromise sterility.

    Product
    NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2869-2017·2017-08-09

    In2Bones Recalls Non-Locking Orthopedic Screws Due to Perioperative Breakage

    In2Bones, SAS is recalling specific non-locking orthopedic screws after customer complaints reported breakage during insertion into the radius bone.

    Product
    Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W27 ST010 (b) NEO(R) 0.27 - 12 mm, REF W27 ST012 (c) DRP 0.27 - 12 mm, REF W27 ST012 (d) NEO(R) 0.27 - 14 mm, REF W27 ST014 (e) NEO(R) 0.27 - 16 mm, REF W27 ST016 (f) NEO(R) 0.27 - 18 mm, REF W27…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2793-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes, creating a potential sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2868-2017·2017-08-09

    Zimmer Biomet Recalls ROSA Brain Surgical Navigation Systems

    Zimmer Biomet is recalling 20 ROSA Brain surgical navigation systems because the head holder connector may lock up mechanically when tightened.

    Product
    ROSA Brain, 3.0.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is…
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-2864-2017·2017-08-09

    Hologic Tomcat Instrument Recalled for Software Anomaly Affecting Sample Processing

    Hologic is recalling 164 Tomcat Instruments due to a software anomaly that may cause the pipettor arm to contact the mucous shelf, potentially leading to incorrect patient results.

    Product
    Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2797-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes, creating a potential sterile barrier breach.

    Product
    NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR CLINICAL USE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2787-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included display sets may have packaging pinholes that compromise sterility.

    Product
    SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2798-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because they may contain Medtronic display sets with packaging pinholes that could breach the sterile barrier.

    Product
    NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2795-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes, creating a risk of sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2792-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have pinholes in their packaging, creating a potential sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2788-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have pinholes in their packaging, creating a risk of sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) REF 044011200, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2784-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have pinholes in their packaging, creating a risk of sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2760-2017·2017-08-09

    Olympus VANTA Analytical X-Ray System Recalled for Proximity Shutdown Failure

    Olympus is recalling 146 VANTA Analytical X-Ray Systems because they may fail to stop testing when no sample is present.

    Product
    Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System, X-Ray Fluorescence
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2786-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes, creating a potential sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2863-2017·2017-08-09

    Spectranetics Turbo-Elite Laser Atherectomy Catheters Recalled for Marker Band Risk

    Spectranetics is recalling Turbo-Elite Laser Atherectomy Catheters because a marker band may become loose or disengaged when the device is used off-label.

    Product
    Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters Device is indicated for use in the treatment, including atherectomy, of infrainguinal stenosis and occlusions
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-2783-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because the included Medtronic display sets may have pinholes, creating a potential sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide