🏥 Medical Devices Class I - Dangerous
Stryker Instruments is recalling the Stryker SelectCore Variable Throw Biopsy Device due to the potential for for the stylet to eject from the SelectCore device during actuation.
All Recalls
95,114 total recalls in our database
Fiber Cleaver; Fiber Cleaver is also used to score the outer jacket on EndoStat Fibers (Aura XP) The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex Fibers. The tool is a one piece pencil-like design with a sharpened blade at the end. The Fiber Cleaver is a SureFlex TM Reusable Laser Lithotripsy fiber and EndoStat fiber accessory. The Fiber Cleaver does not come in direct contact with the patient.
American Medical Systems Innovation Center - Silicon Valley
🏥 Medical Devices Class I - Dangerous
validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products
THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1243 Product Usage: medical aspirator
Gardner Denver Thomas
🏥 Medical Devices Class I - Dangerous
Vacuum pump may not perform to specification.
Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH & Co.
Maquet Cardiovascular Us Sales
🏥 Medical Devices Class I - Dangerous
There is a potential issue that could result to collision between the C-arm of the angiography system and the MAGNUS OR table system. After switching on the angiography-system, in rare cases, MAGNUS column provides wrong position data for the longitudinal movement leading to a collision.
Tool, Stripper W/BLD, 44S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size.
American Medical Systems Innovation Center - Silicon Valley
🏥 Medical Devices Class I - Dangerous
validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products
🏥 Medical Devices Class I - Dangerous
Haptics breaking during lens loading and insertion.
🏥 Medical Devices Class I - Dangerous
Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results
🏥 Medical Devices Class I - Dangerous
Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.
Stripper, 0.4mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size.
American Medical Systems Innovation Center - Silicon Valley
🏥 Medical Devices Class I - Dangerous
validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products
American Catheter / Cholangiogram Catheter 9100 Series.
American Catheter
🏥 Medical Devices Class I - Dangerous
Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution.
🏥 Medical Devices Class I - Dangerous
Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.
🏥 Medical Devices Class I - Dangerous
A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
🏥 Medical Devices Class I - Dangerous
Devon Light Gloves contain splits or holes compromising the sterility
Fiber Stripper, 150¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size.
American Medical Systems Innovation Center - Silicon Valley
🏥 Medical Devices Class I - Dangerous
validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products
Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 459800338451. UPDATED: Pinnacle3 Software Version 8.0h, 8.0k, 8.0m, 8.0n.
Philips Electronics North America
🏥 Medical Devices Class I - Dangerous
Philips, Pinnacle Radiation Treatment Planning System version 8.0h, 8.0k, 8.0m, 8.0n, 9 0, 9 2 9 4, 9 6 is being recalled because the dose may be inconsistent with the density of a density-overridden ROl.
Tool, StripperW/BLD, 10S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size.
American Medical Systems Innovation Center - Silicon Valley
🏥 Medical Devices Class I - Dangerous
validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products
🏥 Medical Devices Class I - Dangerous
Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance.
🏥 Medical Devices Class I - Dangerous
A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
🏥 Medical Devices Class I - Dangerous
Devon Light Gloves contain splits or holes compromising the sterility
🏥 Medical Devices Class I - Dangerous
Devon Light Gloves contain splits or holes compromising the sterility