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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18951–18975 of 27682

  • HighFDA (Devices)·Z-0327-2018·2018-01-17

    Encore Medical Recalls EMPOWR Porous Knee System Tibial Punch

    Encore Medical is recalling two units of the EMPOWR Tibial Punch because the locking guide failed to properly position the implant.

    Product
    EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Qty 1 For use in orthopedic surgery.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0323-2018·2018-01-17

    CareFusion Alaris PCA Pump Recall Due to Syringe Plunger Gripper Failure

    CareFusion is recalling Alaris PCA Pumps because the syringe plunger grippers may fail to close automatically, potentially affecting medication delivery.

    Product
    Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PCA pump delivers medication or fluids in a manner similar to current syringe…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0317-2018·2018-01-17

    Repro-Med Systems Recalls Freedom60 Precision Flow Rate Tubing Sets

    Repro-Med Systems is recalling Freedom60 Precision Flow Rate Tubing Sets and related needle sets because gaps were found in the sterile barrier packaging during inspection.

    Product
    Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200 F180.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0333-2018·2018-01-17

    Philips IQon Spectral CT Scanner Recall Due to Potential Gantry Screw Failure

    Philips is recalling IQon Spectral CT systems because screws holding the internal gantry to the main bearing may come loose, potentially causing noise.

    Product
    Philips Healthcare IQon Spectral CT computed tomography x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0260-2018·2018-01-17

    OrthoScan Recalls Mobile Mini C-arm Systems Due to Software Defect

    OrthoScan is recalling 2,012 Mobile Mini C-arm systems because a software defect allows users to activate Digital Zoom during live imaging, exposing a larger x-ray field than visible.

    Product
    Mobile Mini C-arm system Part # 1000-0005. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0313-2018·2018-01-10

    Smiths Medical Medfusion Syringe Infusion Pump Recall for Clamp Mechanism Defect

    Smiths Medical ASD Inc. is recalling Medfusion Syringe Infusion Pumps because a loose clamp mechanism may cause the device to incorrectly alarm for invalid syringe sizes.

    Product
    Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0316-2018·2018-01-10

    Amendia Recalls Ceres Self-Drilling Variable Screws Due to Incorrect Length Marking

    Amendia, Inc. is recalling 40 Ceres Self-Drilling Variable Screws because some units marked as 12 mm actually measure 14 mm in length.

    Product
    Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are intended to be used with the Ceres-C Stand-Alone Cervical System.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0311-2018·2018-01-10

    Philips Mobile Detector Holder Recalled Due to Potential Detector Drop Hazard

    Philips is recalling 412 Mobile Detector Holders for Stationary X-ray Systems because the lock mechanism may fail, causing the detector to drop.

    Product
    Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable detector free in the room for X-ray exposures. It supports the wireless portable detector with or without a grid.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0315-2018·2018-01-10

    Centurion Recalls Convenience Kits Contaminated with Particulate Matter

    Centurion Medical Products is recalling specific lots of convenience kits containing BD SafetyGlide needles due to particulate contamination.

    Product
    SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in Centurion Convenience Kits. Centurion component code BD17O1NS.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0213-2018·2018-01-03

    Sterilmed recalls reprocessed St. Jude Medical Agilis NxT Steerable Introducers

    Sterilmed Inc is recalling 112 reprocessed St. Jude Medical Agilis NxT Steerable Introducers due to inadequate seals caused by missing adhesive glue.

    Product
    St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0289-2018·2018-01-03

    Accuray TomoHDA System Recalled for Uncontrolled Couch Movement

    Accuray is recalling 87 TomoHDA radiation therapy systems worldwide due to a defect causing uncontrolled couch descent.

    Product
    TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0288-2018·2018-01-03

    Accuray TomoH System Recalled for Uncontrolled Couch Movement

    Accuray is recalling 29 TomoH Systems due to a defect causing uncontrolled couch descent, posing a risk of injury to patients.

    Product
    TomoH(R) System, Model Number 1018284 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0134-2018·2018-01-03

    Simple Diagnostics Recalls Alcohol Prep Pads Due to Sterility Concerns

    Simple Diagnostics is recalling 150,250 alcohol prep pads because the company cannot ensure they are sterile and due to cGMP deviations.

    Product
    Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Sterile, Distributed by Simple Diagnostics, Winston Park, NY NDC 98302-0001-05
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0286-2018·2018-01-03

    Accuray Hi-Art System Recalled for Uncontrolled Couch Movement

    Accuray Incorporated is recalling 250 Hi-Art(R) Systems due to uncontrolled couch Z-axis movement (descent). The affected units are distributed worldwide.

    Product
    Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0270-2018·2018-01-03

    L3 Security Cabinet X-ray System Recalled for Shielding Gaps

    L3 Security & Detection is recalling 471 Examiner 3DX 6000 cabinet X-ray systems used for airline baggage screening due to shielding gaps that may cause excessive X-ray emissions.

    Product
    L3 Security & Detection System Cabinet X-ray system used for security screening of checked airline baggage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0287-2018·2018-01-03

    Accuray TomoHD System Recalled for Uncontrolled Couch Movement

    Accuray is recalling 118 TomoHD radiation therapy systems worldwide due to uncontrolled couch descent.

    Product
    TomoHD(R) System, Model Number 1018283 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0292-2018·2018-01-03

    Philips IntelliVue Patient Monitors Recalled for Distorted ST-Segment Display

    Philips is recalling specific IntelliVue patient monitors and measurement servers because they may display distorted ST-segments during 12-lead ECG monitoring.

    Product
    IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient Monitor Models MP2 and MP5 Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0295-2018·2018-01-03

    Medline Recalls Sterile Elastic Esmark Bandages Due to Sterilization Failure

    Medline Industries is recalling 5,722 units of sterile elastic bandages because they may not have been properly sterilized.

    Product
    Sterile Elastic Esmark Bandage, 3" x 9", individually packaged in a Tyvek plastic form fill seal pouch and placed into a corrugate case, 20 individually packed bandages per case.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0291-2018·2018-01-03

    Orthofix Power Drill Torque Limiter Recalled Due to Breakage Risk

    Orthofix Srl is recalling 416 units of Power Drill Torque Limiters because they may break during surgical use. The devices are used for temporary bone stabilization in lower limb procedures.

    Product
    Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, Galaxy UNYCO Ankle Bridging…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0264-2018·2017-12-27

    BioMerieux Recalls ETEST Oxacillin Strips Due to Quality Control Failures

    BioMerieux SA is recalling ETEST Oxacillin strips due to quality control failures that may cause false resistant results.

    Product
    ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0265-2018·2017-12-27

    BioMerieux Recalls ETEST OXACILLIN Strips Due to Quality Control Failures

    BioMerieux SA is recalling ETEST OXACILLIN OX 256 WW F100 in vitro diagnostic strips due to quality control failures that may cause false resistant results.

    Product
    ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0279-2018·2017-12-27

    Zimmer Dental GemLock Hex Driver Recalled for Manufacturing Defect

    Zimmer Dental Inc. is recalling 356 GemLock RHD2.5 Hex Drivers because a manufacturing defect may prevent the tool from properly engaging dental fixtures.

    Product
    Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0262-2018·2017-12-27

    Rezum System Recall Due to Potential Needle Bond Failure During Prostate Treatment

    NxThera is recalling 113 Rezum System units because the needle bond may fail during deployment, posing a risk of injury to patients.

    Product
    Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc. 7351 Kirkwood Lane Suite 138 Maple Grove, MN 55369 USA. Intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for…
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-0257-2018·2017-12-27

    Terumo Overpressure Safety Valve Recall Due to No Flow Reports

    Terumo CVS is recalling custom surgical kits containing Overpressure Safety Valves due to reports of no flow through the valve.

    Product
    Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130J Catalog numbers: US distribution: LH130 74369 71156 71551-02 71413 71692…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0274-2018·2017-12-27

    Qiagen QIAamp DSP Virus Kit Recalled for Decreased Performance

    Qiagen is recalling specific lots of the QIAamp DSP Virus Kit because they may result in decreased performance in analytic workflows.

    Product
    QIAamp DSP Virus Kit Cat. No. 60704
    Category
    Medical Device
    Distribution
    0 states