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[Recalled] Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator — In certain cases, a collimator may not fully dock, which triggers a system inte… | FDA 2026-06-16

FDA recall notice for Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator (Accuray Incorporated). Reaso

[Recalled] Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator — In certain cases, a collimator may not fully dock, which triggers a system inte… | FDA 2026-06-16

FDA recall notice for Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator (Accuray Incorporated). Reaso

[Recalled] Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Dual Hose with CPC Connectors Model/Catalog Number: 60-1812-101-00 Software Version: N/A Product Description: Dual Sterile Extension Hose wi

FDA recall notice for Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Dual Hose with CPC Connectors Model/Catalog Number:

[Recalled] Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors Model/Catalog Number: 60-4009-101-00 Software Version: N/A Product Description: Single Sterile Extension Hos

FDA recall notice for Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors Model/Catalog Numbe

[Recalled] ARTIS icono ceiling. Model Number: 11328100. — Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the… | FDA 2026-06-08

FDA recall notice for ARTIS icono ceiling. Model Number: 11328100. (Siemens Medical Solutions USA, Inc). Reason: Potential issue with the Display ceiling suspen

[Recalled] Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 Software Version: N/A Product Description: Enteral Extension Set, Length 60 Orange-Striped Minibore Tubing,

FDA recall notice for Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 Software Version: N

[Recalled] Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX. — Potential for device reset to default "

FDA recall notice for Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG

[Recalled] Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw; 3070-27009 2.7mm x 9mm NL Hexalobe Screw; 3070-27010 2.7mm x 10mm NL Hexalobe Screw; 3070-27011 2.7mm x 11mm NL Hexalobe Screw; 307

FDA recall notice for Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw; 3070-27009 2.7mm x 9mm NL Hexalobe Screw;

[Recalled] Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack Model/Catalog Number: STP-AT-012 Software Version: N/A Product Description: Dexcom G7 US Retail Sensor/Tra

FDA recall notice for Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack Model/Catalog Num

[Recalled] Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. Product Usage: Usage: The Benchmark product lines are intended to automatically stain histological or

FDA recall notice for Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. Product Usage

[Recalled] Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems. The affected Sesamoid Plasty components are the central structural co

FDA recall notice for Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software base

[Recalled] Cannulaide, Model 101, 102, 103. Respirator. The Cannulaide product is composed of die-cut hydrocolloid-coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop material to help secu

FDA recall notice for Cannulaide, Model 101, 102, 103. Respirator. The Cannulaide product is composed of die-cut hydrocolloid-coated polyurethane film with

[Recalled] EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, MR Angiography/MR Vascular Imaging, Blood Oxygenation Level Dependent Imaging, Perfusion I D

FDA recall notice for EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, M

[Recalled] Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices. — During two separate occa

FDA recall notice for Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc

[Recalled] Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and blood oxygen data during a sleep study. — The outer jacket is receding away from the black sensor prematurely | FDA 2008

FDA recall notice for Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and blood oxygen data during a sl

[Recalled] PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automated standarized alternative to labor intensive and time consuming dewaxing and epitote retrieval procedures. — Dako is recalling the PT Link Waterbath

FDA recall notice for PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automated standarized alternative to labor intensive and time con

[Recalled] GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. — The reason for this inspection is to determine if

FDA recall notice for GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X

[Recalled] Toshiba CT systems, Asteion and Aquilion, that are equipped with a PC based computer, or to those older systems (SGI based) that received an improved table by an upgrade purchase. This device is designed to produce cross-sect

FDA recall notice for Toshiba CT systems, Asteion and Aquilion, that are equipped with a PC based computer, or to those older systems (SGI based) that received

[Recalled] OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient

FDA recall notice for OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray syste

[Recalled] OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The OEC 8800 is designed to provide fluoroscopic and spot-film imaging of the

FDA recall notice for OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional pr