Medical device recalls
39137 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2021-06-09FDA-DeviceElekta, Inc.Class IIElekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud
Malware attack
- 2021-06-09FDA-DeviceCLINICAL LASERTHERMIA SYSTEMS ABClass IITranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.
single use devices labeled as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceCLINICAL LASERTHERMIA SYSTEMS ABClass IITranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.
single use devices labeled as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceCLINICAL LASERTHERMIA SYSTEMS ABClass IITranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.
single use devices labeled as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceMeta C.G.M. SpaClass IIREF 4890 SMARTSCRAPER CE0123, STERILE EO. Used in oral surgery.
Sterility issues; single use devices labeled as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceMeta C.G.M. SpaClass IIREF: 3598 SAFESCRAPER TWIST, CE 0123, STERILE EO. Used in oral surgery.
Sterility issues; single use devices labeled as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceMeta C.G.M. SpaClass IIREF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery.
Sterility issues; single use devices labeled as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceMeta C.G.M. SpaClass IIREF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery.
Sterility issues; single use devices labeled as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceFujifilm Medical Systems U.S.A., Inc.Class IISynapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can be reused for a new patient. It was discovered that this value does not increase when a patient merge activity is executed in a specific sequence
- 2021-06-09FDA-DevicePhilips North America LlcClass IIBRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury
- 2021-06-09FDA-DeviceCHANGE HEALTHCARE CANADA COMPANYClass IIChange Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content.
A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV.
- 2021-06-09FDA-DeviceMedtronic MinimedClass IIMiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN;¿ PUMP MMT-1740KX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KFX 670G V6.3 SF MG CLIN FR;¿ PUMP MMT-1741KFX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KX 670G V6.3 SF MG CLIN GER;¿ PUMP MMT-1741KX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KXS 670G V6.3 SF MG CLIN IS;¿ PUMP MMT-1741KXS 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1742KX 670G V6.1 MM CLIN;¿ PUMP MMT-1742KX 670G V6.3 SF MM CLIN;¿ PUMP MMT-1742KX 670G V6.3 SF MM CLIN SLO;¿ PUMP
Due to a software design issue, under certain conditions, a software fault is detected when a large bolus delivery at quick bolus speed completes. if the user is not aware of the amount of active insulin and delivers an additional bolus, there is a risk of insulin over delivery.
- 2021-06-09FDA-DeviceMedtronic MinimedClass IIMiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL;¿ PUMP MMT-1886 MM780G 6.5W BLE MG; KIT MMT-1895WW MM780G 6.5V BLE SF MMOL;¿ KIT MMT-1896WW MM780G 6.5W BLE SF MG;¿ PUMP MMT-1884XC 780G V6.5 CLIN US MG;¿ PUMP MMT-1885XC 780G V6.5 CLIN MM;¿ PUMP MMT-1886XC 780G V6.5 CLIN MG;¿ PUMP MMT-1885L MM780G 6.5V BLE MMOL;¿ PUMP MMT-1886L MM780G 6.5W BLE MG;¿ KIT MMT-1896ES MM780G V6.5W MG;¿ KIT MMT-1896WWA MM780G BLE MG ES;¿ KIT MMT-1895WWA MM780G BLE MMOL AR;¿ KIT MMT-18
Due to a software design issue, under certain conditions, a software fault is detected when a large bolus delivery at quick bolus speed completes. if the user is not aware of the amount of active insulin and delivers an additional bolus, there is a risk of insulin over delivery.
- 2021-06-09FDA-DeviceZavationClass IIVERTEBREX SINGLE BALLOON KIT, REF VBRX-20-SBK-10. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass IIVERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass IIOsteoFlex Cement and Mixing System, REF VCF-OSFL. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass IIZVPlasty, 11G, 15mm Traditional Bipedicular Kit, REF VCF-1115-2. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass IIZVplasty System, 20mm, Part# VCF-1020-2. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass IIZVplasty 10G, 20mm, Traditional Unipedicular Kit, REF VCF-1020-1. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass IIZVplasty 10G, 15mm Single Balloon Kit, REF VCF-SBK. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass IIZVplasty 10G, FLEX KYPHOPLASTY, REF VCF-1015-FLEX. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass IIZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass IIZVplasty 10G, 15mm, Additional Level Kit, REF VCF-1015-1A. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass IIZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass IIZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass IIZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass IIZVplasty System, 10mm, Pat# VCF-1010-2. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass IIOsteoFlex BONE CEMENT, REF Numbers: a) INTV-OSFL b) INTV-OSFL-LV. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass IIInterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK c) INTVMN-15-DSKC d) INTVMN-20-DSK. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass IIInterV 10G Bone Access Tools/Kit, REF INTVM-FLNK. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
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