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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24976–25000 of 40357

  • SevereFDA (Devices)·Z-0642-2018·2018-02-28

    Allen Medical Systems Recalls Radiolucent Surgery Spine Frames

    Allen Medical Systems is recalling 161 Radiolucent Surgery Spine Frames because the base may crack during patient transfer.

    Product
    Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0582-2018·2018-02-28

    Medtronic Recalls Amplia MRI CRT-D Devices Due to Therapy Prevention Risk

    Medtronic is recalling 951 Amplia MRI CRT-D devices because they may fail to deliver high or low voltage therapy.

    Product
    Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following: a. Amplia MRI CRT-D DF4 (Product No. DTMB1D4); b. Amplia MRI Quad CRT-D DF1 (Product No. DTMB1Q1); c. Amplia MRI Quad CRT-D DF4 (Product No. DTMB1QQ); EXPANSION: d.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0588-2018·2018-02-28

    Medtronic Recalls Visia AF MRI ICDs Due to Therapy Prevention Risk

    Medtronic is recalling 951 Visia AF MRI ICDs and CRT-Ds because a defect may prevent high and low voltage therapy.

    Product
    Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following: a. Visia AF MRI VR SureScan ICD DF1 (Product No. DVFB1D1); b. Visia AF MRI VR SureScan ICD DF4 (Product No. DVFB1D4); EXPANSION: c. Visia AF MRI S VR SureScan ICD DF1 (Product…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0638-2018·2018-02-28

    ROSA Brain 3.0 Stereotaxic Instrument Recalled for Positioning Errors

    Zimmer Biomet is recalling 16 ROSA Brain 3.0 Stereotaxic instruments because the robot arm may move to the wrong position during surgery.

    Product
    ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons.
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0641-2018·2018-02-28

    Allen Medical Bow Frame Recalled Due to Potential Base Cracking

    Allen Medical Systems is recalling 161 Bow Frame Model A-70800 surgical platforms because the base may crack when patients are transferred onto the device.

    Product
    Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0585-2018·2018-02-28

    Medtronic Recalls 951 Evera MRI ICDs Due to Therapy Prevention Risk

    Medtronic is recalling 951 Evera MRI ICDs and CRT-Ds because a defect may prevent high and low voltage therapy. Patients should contact their healthcare provider.

    Product
    Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following: a. Evera MRI XT DR ICD DF1 (Product No. DDMB1D1); b. Evera MRI XT DR ICD DF4 (Product No. DDMB1D4); c. Evera MRI XT VR ICD DF4 (Product No. DVMB1D4); d. Evera MRI S DR ICD DF1…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0586-2018·2018-02-28

    Medtronic Recalls Claria MRI CRT-Ds Due to Therapy Prevention Risk

    Medtronic is recalling 951 Claria MRI CRT-Ds because a defect may prevent the devices from delivering high or low voltage therapy.

    Product
    Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Labeled as the following: a. Claria MRI CRT-D DF1 (Product No. DTMA1D1); b. Claria MRI Quad CRT-D DF4 (Product No. DTMA1QQ); EXPANSION: c. Claria MRI CRT-D DF4 (Product No. DTMA1D4); d.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0589-2018·2018-02-28

    Medtronic Visia AF ICDs Recalled for Potential Therapy Failure

    Medtronic is recalling 951 Visia AF ICDs and CRT-Ds because they may fail to deliver high or low voltage therapy.

    Product
    Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. Visia AF VR ICD DF1 (Product No. DVAB1D1); EXPANSION: b. Visia AF" VR ICD DF4 (Product No. DVAB1D4) Implantable devices that automatically detect and treat episodes of ventricular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0640-2018·2018-02-28

    GastriSail Gastric Positioning Device Recalled Due to Perforation Reports

    FDA is recalling 17,271 units of the GastriSail Gastric Positioning Device due to reports of gastric or esophageal perforation during surgical procedures.

    Product
    GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning system is indicated for use in gastric and bariatric surgical procedures for the application of suction, decompression and to radially expand the stomach, to drain gastric fluids, to test…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0639-2018·2018-02-28

    Zimmer Biomet Recalls ROSA Spine Stereotaxic Instrument Due to Positioning Error

    Zimmer Biomet is recalling one ROSA Spine 1.0.2 Stereotaxic instrument because the robot arm may move to the wrong position during surgery.

    Product
    ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by surgeons.
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0584-2018·2018-02-28

    Medtronic Viva CRT-D Recall for Possible Prevention of Therapy

    Medtronic is recalling 951 Viva CRT-D devices due to a potential issue that may prevent high and low voltage therapy.

    Product
    Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the following: a. Viva Quad S CRT-D DF4 (Product No. DTBB1QQ); b. Viva Quad XT CRT-D DF4 (Product No. DTBA1QQ); c. Viva S CRT-D DF1 (Product No. DTBB1D1); d. Viva XT CRT-D DF1 (Product No.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0688-2018·2018-02-28

    Merit Medical Recalls Prelude SNAP Splittable Sheath Introducers

    Merit Medical Systems is voluntarily recalling specific lots of Prelude SNAP Splittable Sheath Introducers due to an intermittent failure of the splittable hub.

    Product
    PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, PLS-1010, PLS-1010.5, PLS-1011, PLS-2506, PLS-2507, PLS-2508, PLS-2509, PLS-2510, PLS-2510.5, PLSH-1006, PLSH-1009, PLSX-1006, PLSX-1007…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0682-2018·2018-02-28

    Vygon Recalls 3-Way Stopcocks Due to Packaging Sterility Concerns

    Vygon is voluntarily recalling 200 units of 3-Way Standardbore Stopcocks because packaging adhesive issues may compromise product sterility.

    Product
    3-Way Standardbore Stopcock. Product Code: AMS-100.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0645-2018·2018-02-28

    Medtronic Recalls Affinity NT Cardiotomy Reservoirs Due to Sterile Barrier Breach

    Medtronic is recalling Affinity NT Cardiotomy/Venous Reservoirs because of a possible sterile barrier breach in the pouch.

    Product
    Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood is collected and de foamed…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0671-2018·2018-02-28

    Med Tec Protura Software Recalled for Pedestal Coordinate Errors

    Med Tec Inc is recalling Protura software versions that may fail to update pedestal location data, potentially affecting treatment table movements.

    Product
    Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, MT6SXM1.4.0-3, MT6XSM1.5.0-2, MT6XSM1.6.0-1, MT6XSM1.7.2, MT6XSM1.7.2-1, MT6XSM1.7.2-3, MT6XSM1.7.3, MT6XSM1.7.3-1, MT6XSM1.7.3-3. The Protura Software is intended to…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0650-2018·2018-02-28

    Arrow International Recalls Multi Lumen Central Venous Catheterization Kits

    Arrow International is recalling 5,926 Multi Lumen Central Venous Catheterization Kits because they may contain the incorrect Springwire Guide.

    Product
    Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0655-2018·2018-02-28

    Arrow International Recalls Multi Lumen Central Venous Catheterization Kits

    Arrow International Inc is recalling specific lots of AGB+ Multi Lumen Central Venous Catheterization Kits because they may contain the incorrect Springwire Guide.

    Product
    AGB+ Multi Lumen Central Venous Catheterization Kit; Product Codes: CDC-42703-XP1A and CDC-47702-XP1A; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0644-2018·2018-02-28

    Innovasis Recalls Nine Lots of 8.5 mm Polyaxial Pedicle Screws

    Innovasis, Inc. is recalling nine lots of 8.5 mm Polyaxial Pedicle Screws due to a risk of breakage. The recall covers 1,010 parts distributed in the United States.

    Product
    Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0636-2018·2018-02-28

    FDA Recalls Endo GIA Auto Suture Units Due to Safety Interlock Failure

    The FDA is recalling 3,816 Endo GIA Auto Suture Universal Articulating Loading Units because the safety interlock may fail, allowing an empty unit to be fired a second time.

    Product
    Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0646-2018·2018-02-28

    Medtronic Cardiotomy Reservoir Recall for Possible Sterile Barrier Breach

    Medtronic is recalling Affinity NT Cardiotomy Venous Reservoirs due to a possible sterile barrier breach in the pouch.

    Product
    Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter,with Trillium Biosurface, 540T The AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0637-2018·2018-02-28

    DeRoyal recalls custom sterile surgical packs with Terumo valve defect

    DeRoyal Industries Inc is recalling 181 custom sterile surgical packs distributed in New York due to a Terumo valve defect causing no flow.

    Product
    Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0685-2018·2018-02-28

    Boston Scientific Recalls Innova Self-Expanding Stent Systems Due to Release Defect

    Boston Scientific is recalling 22,916 units of the Innova Self-Expanding Stent System because the stent may not fully release from the delivery system.

    Product
    Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0686-2018·2018-02-28

    Boston Scientific Recalls Innova Self-Expanding Stent Systems Due to Release Defect

    Boston Scientific is recalling 22,916 Innova Self-Expanding Stent Systems because they may not fully release from the delivery system.

    Product
    Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0675-2018·2018-02-28

    Roche Cobas 8000 Modular Series Software Recall for Incorrect Results Risk

    Roche Diagnostics is recalling 399 Cobas 8000 Modular Series systems due to a software failure that may reset settings to defaults, creating a risk of incorrect test results.

    Product
    Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-0662-2018·2018-02-28

    Fujifilm Recalls Mammography Software Due to Potential Image Overwrite Error

    Fujifilm is recalling 71 units of the Fuji Computed Radiography Mammography Suite because a software error may cause new images to overwrite previous ones in the hospital system.

    Product
    Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiography Mammography Suite (FCRMS) is a software device that, in conjunction with a specified Fuji Computed Radiography system forms the Fuji Computed Radiography for mammography (FCRm)…
    Category
    Medical Device
    Distribution
    0 states