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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22476–22500 of 27699

  • HighFDA (Devices)·Z-0408-2016·2015-12-23

    Philips Ingenuity CT Scanner Software Error Recalled by FDA

    The FDA is recalling 105 Philips Ingenuity CT scanners because software errors can cause the scan length to differ from the user's plan.

    Product
    Philips Healthcare Ingenuity CT Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0428-2016·2015-12-23

    bioMerieux MYLA Software Recalled for Potential Patient Record Mismatch

    bioMerieux is recalling MYLA software due to a potential risk of linking test results to incorrect patient records when connected to specific laboratory systems.

    Product
    MYLA MASTER DVD V4.0 CLI Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0407-2016·2015-12-23

    Philips CT Scanner Software Error May Alter Scan Length

    Philips is recalling 105 Ingenuity Core 128 CT scanners because software may unexpectedly change the scan length during specific protocols.

    Product
    Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0431-2016·2015-12-23

    bioMerieux MYLA CLI Software Recalled for Patient Data Linking Errors

    bioMerieux is recalling MYLA CLI software versions 3.x to 4.1 because it may link test results to incorrect patient records.

    Product
    MYLA CLI V3.X TO V4.1 ML350 SERVER Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0421-2016·2015-12-23

    Verathon GlideScope AVL Video Laryngoscope Blades Recalled for Separation Risk

    Verathon is recalling GlideScope AVL video laryngoscope blades because silicone adhesive bonding may be inadequate, creating a risk of blade separation during use.

    Product
    GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-0574-0116, AVL 5- 0574-0117. AVL is a video laryngoscope that incorporates a high resolution color camera, an LED light source and video output to a remote monitor. This system has a digital…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0374-2016·2015-12-16

    Philips IntelliVue Information Center iX Software Recall for Alarm Failure

    Philips is recalling IntelliVue Information Center iX software because SpO2 and NBP alarms may disable without visual notification.

    Product
    Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX 866024 PIIC iX Upgrade 866117 PIIC Classic Upgrade The intended use of the Information Center Software is to display physiologic waves…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0385-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise packaging sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0378-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Defect

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0382-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing defect that may compromise packaging sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0409-2016·2015-12-16

    Philips Brilliance 64 CT System Recalled for Software Defects

    Philips is recalling 1,765 Brilliance 64 CT systems worldwide due to software defects that may cause operational errors, image issues, or misdiagnosis.

    Product
    Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0375-2016·2015-12-16

    Synthes Recalls Five TFN-Advanced Proximal Femoral Nailing Systems

    Synthes (USA) Products LLC is recalling five TFN-Advanced Proximal Femoral Nailing Systems because a design defect may prevent proper locking mechanism advancement or screw tightening.

    Product
    Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal Femoral Nailing System) The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures. Intramedullary fixation rod, orthopedic.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0396-2016·2015-12-16

    Implant Direct Sybron Recalls DirectGuide Drill Extender for Dental Implants

    Implant Direct Sybron Manufacturing is recalling 26 lots of DirectGuide Drill Extenders because the drill may drop during use.

    Product
    DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable for individual patient needs. The thru hole in the DGDE allows existing surgical drills to be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0402-2016·2015-12-16

    Boston Scientific Recalls One Step Button PEG Kits Due to Adapter Defect

    Boston Scientific is voluntarily recalling specific lots of One Step Button PEG kits because a protrusion on the decompression tube adapter may prevent the device from being inserted or removed.

    Product
    One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0411-2016·2015-12-16

    Zimmer Persona EM Distal Rod Recalled for Ratchet Latching Defect

    Zimmer, Inc. is recalling 156 Persona EM Distal Rods because the ratchet teeth may not latch onto the rod. The defect could affect the stability of the surgical instrument during use.

    Product
    Persona EM Distal Rod, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-002-00, part of the Persona Tibial Resection System.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-0380-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recall for Packaging Defect

    LeMaitre Vascular is recalling Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0410-2016·2015-12-16

    Zimmer Persona EM Proximal Tube Recalled for Ratchet Latching Failure

    Zimmer, Inc. is recalling 156 Persona EM Proximal Tubes because the ratchet teeth may not latch onto the rod.

    Product
    Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-001-00, part of the Persona Tibial Resection System.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-0404-2016·2015-12-16

    Sterilmed Recalls Reprocessed Tourniquet Cuffs Due to Sterility Concerns

    Sterilmed is voluntarily recalling reprocessed tourniquet cuffs because the company cannot assure the sterility of all units in the affected lots.

    Product
    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0401-2016·2015-12-16

    GE Revolution CT Scanners Recalled for Potential Head Scan Artifacts

    GE Medical Systems is recalling 125 Revolution CT scanners worldwide due to potential image artifacts in head scans that may mimic pathology. No injuries have been reported.

    Product
    GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0384-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Defect

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing issue that could compromise sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0400-2016·2015-12-16

    Philips Brilliance CT Scanner Software Recall for Incorrect Tumor Localization

    Philips is recalling Brilliance CT scanners with software version 2.0 because a printing error may display incorrect tumor locations, potentially leading to patient mistreatment.

    Product
    Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended to provide cross sectional images of the human body and visualization of the internal organs of the body.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0399-2016·2015-12-16

    Visicu eCareManager Software Recalled for Medication Order Defect

    Visicu, Inc. is recalling 43 units of eCareManager software due to a defect that may cause incorrect medication orders to be displayed and signed.

    Product
    The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. For use in a hospital environment. eCareManager…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0388-2016·2015-12-16

    LeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling 4,315 embolectomy catheters worldwide due to a manufacturing defect that may compromise packaging sterility.

    Product
    LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0403-2016·2015-12-16

    Olympus ENDOEYE HD II Video Telescopes Recalled Due to Overheating Tip

    Olympus is recalling 182 ENDOEYE HD II video telescopes because a damaged temperature sensor can cause the tip to overheat, posing a burn risk to patients and users.

    Product
    Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD II 10 mm, 30 degree, W7100603 Repair cable 10 mm 0/30 degree. The ENDOEYE video Telescopes are used with other supporting equipment for endoscopy and endoscopic surgery…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0351-2016·2015-12-09

    Philips Allura Xper Cardio Systems Recalled for Ceiling Suspension Fall Risk

    Philips Medical Systems is recalling 16 Allura Xper cardio systems because the monitor ceiling suspension system may fall.

    Product
    Philips Healthcare Xper cardio systems Model : 722123 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0354-2016·2015-12-09

    Philips Xper Vascular System Monitor Ceiling Suspension Recall

    Philips Medical Systems is recalling 22 Allura Xper vascular systems because the monitor ceiling suspension system may fall.

    Product
    Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization…
    Category
    Medical Device
    Distribution
    Distributed nationwide