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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21176–21200 of 27682

  • HighFDA (Devices)·Z-2642-2016·2016-08-31

    Ziehm Vision R Mobile C-arm Recalled for Radiation Warning Timer Malfunction

    Ziehm Imaging Inc is recalling one Ziehm Vision R Mobile C-arm device because its radiation-warning timer and 3D-specific interval warning malfunction, preventing alerts until the unit is rebooted.

    Product
    Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2640-2016·2016-08-31

    Ziehm Vision RFD Mot Mobile C-arm Recalled for Timer Malfunction

    Ziehm Imaging is recalling 14 mobile C-arm devices because the radiation-warning timer and 3D interval warning may fail to alert users until the unit is rebooted.

    Product
    Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2639-2016·2016-08-31

    Ziehm Vision RFD 3D Mobile C-arm Recalled for Timer Malfunction

    Ziehm Imaging Inc is recalling 31 mobile C-arm devices because the radiation-warning timer and 3D interval warning may fail to alert users until the unit is rebooted.

    Product
    Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2645-2016·2016-08-31

    Medtronic Recalls DBS Pocket Adaptors Due to Conductor Wire Fracture Risk

    Medtronic is recalling DBS Pocket Adaptors Models 64001 and 64002 due to potential conductor wire fractures. A safety notification was sent to healthcare professionals regarding device handling and integrity checks.

    Product
    DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neurostimulation system for deep brain stimulation. The pocket adaptor is intended to be implanted with the new replacement…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2599-2016·2016-08-31

    Conmed Pediatric Dual Dispersive Electrodes Recalled for Burn Risk

    Conmed is recalling 4,560 pediatric dual dispersive electrodes because they may be incompatible with some generators, risking undetected pad lift and potential burns.

    Product
    Pediatric Dual Dispersive Electrodes (for patients 5-15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC¿ generators or conventional electrosurgery units with similar contact monitoring systems…
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2658-2016·2016-08-31

    Philips Ingenuity Core128 CT Systems Recalled for Image Reconstruction Defect

    Philips is recalling three Ingenuity Core128 CT systems because a software upgrade can cause planned anatomy to be cut off in gated helical scan images.

    Product
    Ingenuity Core128, Model number 728323 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2595-2016·2016-08-31

    Conmed Dual Dispersive Electrodes Recalled for Burn Risk

    Conmed is recalling Adult ThermoGard Dual Dispersive Electrodes because they may be incompatible with some electrosurgical generators, posing a risk of undetected pad lift and potential burns.

    Product
    Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), 10' (3.05m) Cable, Catalog Number 51-7310. Intended to be used for the dispersion and return to the electrosurgical generator.
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2602-2016·2016-08-31

    Medtronic Recalls DBS Lead Kits Due to Potential Insulation Damage

    Medtronic is voluntarily recalling 70 unused DBS lead kits from three lots due to potential insulation damage identified during manufacturing.

    Product
    Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2648-2016·2016-08-31

    Bovie Precise 360 Handpiece Recalled for Incomplete Adhesive Bond

    Bovie Medical Corporation is recalling 95 units of the BVX-450BR Bovie Precise 360 Handpiece because the adhesive bond to the angled tip may be incomplete.

    Product
    BVX-450BR Bovie Precise 360 Handpiece 45cm, blade Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2643-2016·2016-08-31

    Ziehm Solo Mobile C-arm Recalled for Radiation Warning Timer Malfunction

    Ziehm Imaging Inc is recalling 12 Ziehm Solo Mobile C-arms because the radiation-warning timer and 3D-specific interval warning may fail to alert users until the unit is rebooted.

    Product
    Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2638-2016·2016-08-31

    Medtronic Recalls Alpha Total Knee Replacement Tibial Tray Components

    Medtronic is recalling specific Alpha total knee replacement tibial trays that may not have been passivated according to manufacturing requirements.

    Product
    TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2608-2016·2016-08-31

    Richard Wolf Conical Portio Adapter Recall Due to Weld Defect

    Richard Wolf Medical Instruments Corp. is recalling specific batches of Conical Portio Adapters because an improper weld may cause the device to separate during use.

    Product
    Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological laparoscopy, to determine patency of the fallopian tubes.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2634-2016·2016-08-31

    Medtronic Recalls Alpha Total Knee Replacement Components for Passivation Defect

    Medtronic Sofamor Danek USA Inc is recalling four units of Alpha total knee replacement femoral components that may not have been passivated according to requirements.

    Product
    RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 3L, REF 90-SRK-312300, QTY: 1, STERILE R,
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2635-2016·2016-08-31

    Medtronic Recalls Tibial Tray Components Due to Passivation Defect

    Medtronic is recalling three units of tibial tray components for total knee replacement because they may not have been passivated correctly.

    Product
    TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2604-2016·2016-08-31

    Innokas Medical Recalls CARESCAPE VC150 Vital Signs Monitors for Software Error

    Innokas Medical Oy is recalling 1,715 CARESCAPE VC150 Vital Signs Monitors because a software error may provide incorrect time data to measurements.

    Product
    CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2668-2016·2016-08-31

    Vision RT TrueBeam and Edge Radiotherapy Systems Recalled for Parameter Errors

    Vision RT Ltd is recalling 47 TrueBeam and EDGE radiotherapy systems because unintended changes to couch rotation parameters were discovered during patient set-up.

    Product
    TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2637-2016·2016-08-31

    Medtronic Recalls Alpha Total Knee Replacement Tibial Tray Components

    Medtronic is recalling two units of Alpha total knee replacement tibial trays that may not have been passivated according to job traveler requirements.

    Product
    TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2657-2016·2016-08-31

    Philips Ingenuity Core CT Systems Recalled for Image Reconstruction Defect

    Philips is recalling 30 Ingenuity Core CT systems because a software upgrade can cause planned anatomy to be cut off in gated helical scans.

    Product
    Ingenuity Core, Model number 728321 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2598-2016·2016-08-31

    Conmed Dual Dispersive Electrodes Recalled for Potential Burn Risk

    Conmed Corporation is recalling Adult Dual Dispersive Electrodes because they may be incompatible with some electrosurgical generators, creating a risk of undetected pad lift and potential burns.

    Product
    Adult Dual Dispersive Electrodes (for patients >15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC¿ generators or conventional electrosurgery units with similar contact monitoring systems, 10'…
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2667-2016·2016-08-31

    Vision RT AlignRT Plus System Recalled for Unintended Couch Parameter Changes

    Vision RT Ltd is recalling 47 AlignRT Plus systems because unintended changes to couch rotation parameters were discovered during patient set-up. No patient harm was reported.

    Product
    AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2533-2016·2016-08-24

    Baxter Recalls VASCU-GUARD Patches Due to Bleeding Reports

    Baxter Healthcare is recalling VASCU-GUARD Peripheral Vascular Patches due to postmarketing reports of intraoperative and postoperative bleeding, including one fatal outcome.

    Product
    Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N, 1 cm x 10 cm, product code VG0110N, and 2 cm x 9 cm, product code VG0209N. VASC U-GUARD is prepared from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2403-2016·2016-08-24

    OraSure Recalls OraQuick Ebola Rapid Antigen Test Due to Stability Failures

    OraSure Technologies is recalling 3,075 units of the OraQuick Ebola Rapid Antigen Test because stability testing revealed intermittent false negative results.

    Product
    OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2567-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recalled for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Flat L-Hook Electrodes due to a potential sterile barrier breach. The recall covers 119,770 units distributed worldwide.

    Product
    Valleylab Laparoscopic Flat L-Hook Electrode 36CM Item Code: E277436 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2575-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Wire L-Hook Electrodes due to a potential sterile barrier breach. The recall covers 50,055 units distributed worldwide.

    Product
    Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R36ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2577-2016·2016-08-24

    Medtronic Recalls Laparoscopic Electrode Due to Sterile Barrier Compromise Risk

    Medtronic is recalling 3,470 Valleylab Laparoscopic Flat L-Hook Electrodes because the package may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Flat L-Hook Electrode Retractable Item Code: E2784R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction…
    Category
    Medical Device
    Distribution
    Distributed nationwide