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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33651–33675 of 40325

  • ModerateFDA (Devices)·Z-0981-2015·2015-01-21

    Straumann Dental Implant Drill Set Recalled for Incorrect Drill

    Straumann USA is recalling dental implant drill sets that may contain incorrect drills. The recall covers 362 pieces distributed nationwide and internationally.

    Product
    Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0985-2015·2015-01-21

    GE Healthcare Recalls Revolution CT Scanners for Bolted Joint Torque Check

    GE Healthcare is recalling 13 Revolution CT scanners to perform a required torque check on three bolted joints. No injuries or illnesses have been reported.

    Product
    GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0982-2015·2015-01-21

    Biomet Spine Recalls Anchored Lateral Retractable Drills Due to Sizing Defect

    Biomet Spine is recalling 15 Anchored Lateral Retractable Drills because the shaft diameter is oversized, causing interference when inserted into sleeve assemblies.

    Product
    Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timberline Anchored Lateral Retractable Drills are used with the Timberline MPF System to establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0965-2015·2015-01-21

    Biocare Medical Recalls MUM-1 Antibody Lots Due to Staining Intensity Issues

    Biocare Medical is recalling three lots of MUM-1 antibody because staining intensity drops over time, potentially affecting diagnostic accuracy.

    Product
    MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; Product Usage: For In Vitro Diagnostic Use. This antibody may be used as a tool for the identification and the sub classification of lymphoid malignancies : Multiple myeloma oncogene-1 (MUM-1) is a protein…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0983-2015·2015-01-21

    Biomet Spine Recalls Timberline Anchored Lateral Fixed Retractable Sleeves

    Biomet Spine is recalling 14 Timberline Anchored Lateral Fixed Retractable Sleeves because the inner diameter is undersized, causing interference fit when inserting instruments.

    Product
    Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Lateral Fixed Retractable Sleeves are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae. The…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0969-2015·2015-01-21

    Ortho VITROS 5600 System Recalled for Software Calibration Error

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems because software may fail to identify expired calibrations.

    Product
    VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0968-2015·2015-01-21

    Ortho VITROS 4600 Chemistry System Recalled for Software Calibration Error

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because software versions 3.1 and below may fail to identify expired calibrations.

    Product
    VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, IVD --- Ortho Clinical Diagnostics. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0854-2015·2015-01-21

    Siemens Artis zee/zeego Systems Recalled for X-Ray Tube Focal Spot Failure

    Siemens Medical Solutions is recalling 44 Artis zee/zeego angiography systems because the small focus of the x-ray tube may fail, causing a short interruption in procedures.

    Product
    Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures…
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-0988-2015·2015-01-21

    Ziemer Femto LDV Z-Generation Lasers Recalled for Missing Starter Kits

    Ziemer USA Inc. is recalling 26 Femto LDV Z-Generation femtosecond surgical lasers because they were not shipped with the required Starter Kits.

    Product
    Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0841-2015·2015-01-21

    GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Recall for Accuracy Issues

    GE OEC Medical Systems is recalling 61 mobile C-Arm X-ray units because their accuracy may exceed the design specification of +10%.

    Product
    GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0967-2015·2015-01-21

    Ortho VITROS 3600 Immunodiagnostic System Recalled for Software Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 3600 systems because software versions 3.1 and below may fail to identify expired calibrations.

    Product
    VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0986-2015·2015-01-21

    Stryker Recalls SurgiCounter Charging Cradles Due to Charging Defects

    Stryker is recalling 3,625 SurgiCounter Charging Cradles because they may fail to charge the scanner or download data after surgical procedures.

    Product
    The SurgiCounter Charging Cradle Product Usage: SurgiCounter Charging Cradles are designed to be used with the SurgiCounter and are part of the SurgiCount Safety-Sponge System. The SurgiCount Safety-Sponge System is indicated for use in counting and recording the number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0840-2015·2015-01-21

    GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Recall for Accuracy Deviation

    GE OEC Medical Systems is recalling 61 mobile C-Arm X-ray units because the accuracy of the x-ray tube potential and current may exceed the manufacturer's specified limits.

    Product
    GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0970-2015·2015-01-21

    Stelkast Recalls EXp Tibial Inserts Due to Manufacturing Defect

    Stelkast Co is recalling 553 EXp Tibial Inserts because a missing lead-in radius may make it difficult to lock the inserts into tibial trays.

    Product
    EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems; and b. Revision of failed previous…
    Category
    Medical Device
    Distribution
    10 states
  • LowFDA (Devices)·Z-0990-2015·2015-01-21

    Med Tec Recalls Short Wool Wrist Loops for Shoulder Retractors

    Med Tec Inc is recalling specific wool wrist loops for shoulder retractors because they were manufactured 7cm shorter than specifications.

    Product
    Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pairs of wrist loops (nylon and sherpa), Non-sterile re-usable wool wrist strap, REF: 20SR03, Rx The devise is intended to pull patients shoulders down for clearance when treating lateral fields to…
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Devices)·Z-0964-2015·2015-01-21

    Mentor MemoryGel Resterilizable Gel Sizer Recalled for Incorrect Instructions

    Mentor Texas, LP. is recalling 45 units of MENTOR MemoryGel Resterilizable Gel Sizers because they contain incorrect instructions for use.

    Product
    MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.
    Category
    Medical Device
    Distribution
    17 states
  • LowFDA (Devices)·Z-0991-2015·2015-01-21

    Tecan Infinite 200 Microplate Reader Recalled for Incorrect Firmware Version

    Tecan US, Inc. is recalling eight Infinite 200 microplate readers because they were shipped with the incorrect lumi firmware version (E.027 instead of V2.00).

    Product
    Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The infinite 200 has been designed as a…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0989-2015·2015-01-21

    Med Tec Recalls Short Wool Wrist Loops for Shoulder Retractors

    Med Tec Inc is recalling 11 units of a wool wrist loop component for shoulder retractors because the items were manufactured 7cm shorter than specifications.

    Product
    Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile re-usable wool wrist strap, REF: 20SR02SUB2, Rx Only, The devise is intended to pull patients shoulders down for clearance when treating lateral fields to the neck.
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Devices)·Z-0992-2015·2015-01-21

    Tecan Infinite 200PRO Microplate Reader Recalled for Firmware Error

    Tecan US, Inc. is recalling Infinite 200PRO microplate readers due to an incorrect firmware version installed on the devices.

    Product
    Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The infinite 200 has been designed as…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0905-2015·2015-01-14

    DePuy ATTUNE INTUITION Impactors Recalled Due to Fracture Risk

    DePuy Orthopaedics is recalling ATTUNE INTUITION Impactors because they have broken and produced small pieces that could be left in patients during knee replacement surgery.

    Product
    Femoral Impactor ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0880-2015·2015-01-14

    Alere INRatio PT/INR Test Strips Recalled for Inaccurate Results

    Alere San Diego, Inc. is recalling INRatio PT/INR Test Strips because the system may provide INR results significantly lower than reference laboratory methods.

    Product
    Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071 Alere INRatio PT/INR Test Strips, Box of 12 - 0100139 Alere INRatio PT/INR Test Strips, Box of 48 The test strips are packaged in individually pouched test strips in a labeled box with 12…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0903-2015·2015-01-14

    DePuy ATTUNE INTUITION Impactors Recalled for Fracture Risk During Surgery

    DePuy Orthopaedics is recalling ATTUNE INTUITION Impactors because they have broken and produced small pieces that could be left in patients during knee replacement surgery.

    Product
    Fixed Tibial bearing ATTUNE INTUITION Impactor The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0904-2015·2015-01-14

    DePuy ATTUNE INTUITION Impactors Recalled Due to Fracture Risk

    DePuy Orthopaedics is recalling ATTUNE INTUITION Impactors because they may break during knee surgery, potentially leaving small fragments in the patient.

    Product
    Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0921-2015·2015-01-14

    Trumpf Medical Systems Recalls JUPITER U Remote Controls for Unintended Movement

    Trumpf Medical Systems is recalling JUPITER U remote controls because damaged units may cause unintended movement of operating tables during surgery.

    Product
    IR remote control JUPITER U, Material no. 4500120, Serial number: to (incl.) 102306940. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer…
    Category
    Medical Device
    Distribution
    25 states
  • SevereFDA (Devices)·Z-0881-2015·2015-01-14

    Alere INRatio Monitors Recalled for Potential Inaccurate INR Results

    Alere San Diego, Inc. is recalling INRatio PT/INR Monitor systems because they may provide INR results significantly lower than reference laboratory methods.

    Product
    INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 0100007 INRatio Prothrombin Time (PT) Monitoring System - 0100137 Alere INRatio Replacement Monitor The test systems contain individually packaged components needed to use the product, such as a monitor…
    Category
    Medical Device
    Distribution
    Distributed nationwide