Medical DeviceDec 28, 2022
Baxter Healthcare Revaclear 400 dialyzers recall — FDA Z-0764-2023
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
Class IIFDA: OngoingBaxter Healthcare Corporation
Recall records from December 2022
These records include useful source details for the selected month.
Medical DeviceDec 28, 2022
Baxter Healthcare Revaclear 400 Dialyzer recall — FDA Z-0760-2023
Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceDec 28, 2022
GE Medical Systems Centricity PACS-IW with Universal Viewer version 5.0 recall — FDA Z-0721-2023
There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance,…
Class IIFDA: OngoingGE Medical Systems, LLC
Medical DeviceDec 28, 2022
Natus Medical The Natus Cranial Access Kit is designed to be a complete, single use and recall — FDA Z-0735-2023
Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical drapes are being recalled due to the liner on the adhesive component is difficult to remove…
Class IIFDA: OngoingNatus Medical Inc.
Medical DeviceDec 28, 2022
GE Medical Systems B125M Patient Monitor, REF 6160000-005-XXXXXXX recall — FDA Z-0733-2023
GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate…
Class IIFDA: OngoingGE Medical Systems, LLC
Medical DeviceDec 28, 2022
GE Medical Systems Vivid i N ultrasound recall — FDA Z-0758-2023
Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.
Class IIFDA: OngoingGE Medical Systems, LLC
Medical DeviceDec 28, 2022
HeartWare HVAD Pump Kit, REF 1104JP recall — FDA Z-0748-2023
Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline…
Class IIFDA: OngoingHeartware, Inc.
Medical DeviceDec 28, 2022
HeartWare HVAD Pump Kit, REF 1205 recall — FDA Z-0749-2023
Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline…
Class IIFDA: OngoingHeartware, Inc.
Medical DeviceDec 28, 2022
GE Medical Systems Vivid S6 N ultrasound recall — FDA Z-0755-2023
Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.
Class IIFDA: OngoingGE Medical Systems, LLC
Medical DeviceDec 28, 2022
Companion Medical InPen Diabetes Management App, part of the InPen System, REF recall — FDA Z-0741-2023
Diabetes management app may crash immediately upon opening, while using the app and/or while app is running in the background, which may lead to inability to use the app. An error message…
Class IIFDA: OngoingCompanion Medical, Inc.
Medical DeviceDec 28, 2022
HeartWare Model 1102 recall — FDA Z-0744-2023
Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline…
Class IIFDA: OngoingHeartware, Inc.
Medical DeviceDec 28, 2022
Baxter Healthcare Revaclear 400 Dialyzer recall — FDA Z-0761-2023
Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceDec 28, 2022
GE Medical Systems B105M Patient Monitor, REF 6160000-003 recall — FDA Z-0731-2023
GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate…
Class IIFDA: OngoingGE Medical Systems, LLC
Medical DeviceDec 28, 2022
HeartWare HVAD Pump Kit, REF MCS1705PU recall — FDA Z-0750-2023
Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline…
Class IIFDA: OngoingHeartware, Inc.
Medical DeviceDec 28, 2022
GE Medical Systems B125P Patient Monitor recall — FDA Z-0730-2023
GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate…
Class IIFDA: OngoingGE Medical Systems, LLC
Medical DeviceDec 28, 2022
NuVasive X-CORE 2 Ti Core, Static recall — FDA Z-0738-2023
Potential that insert will be unable to disengage from the vertebral body replacement device/implant
Class IIFDA: OngoingNuVasive Inc.
Medical DeviceDec 28, 2022
GE Medical Systems Vivid q N ultrasound recall — FDA Z-0759-2023
Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.
Class IIFDA: OngoingGE Medical Systems, LLC
Medical DeviceDec 28, 2022
GE Medical Systems Vivid q ultrasound recall — FDA Z-0757-2023
Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.
Class IIFDA: OngoingGE Medical Systems, LLC
Medical DeviceDec 28, 2022
HeartWare HVAD Pump Kit, REF 1104 recall — FDA Z-0746-2023
Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline…
Class IIFDA: OngoingHeartware, Inc.
Medical DeviceDec 28, 2022
GE Medical Systems Centricity Universal Viewer 6.0 recall — FDA Z-0722-2023
There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance,…
Class IIFDA: OngoingGE Medical Systems, LLC
Medical DeviceDec 28, 2022
GE Medical Systems B125M Patient Monitor, REF 6160000-004-XXXXXX recall — FDA Z-0732-2023
GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate…
Class IIFDA: OngoingGE Medical Systems, LLC
Medical DeviceDec 28, 2022
GE Medical Systems B105P Patient Monitor recall — FDA Z-0729-2023
GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate…
Class IIFDA: OngoingGE Medical Systems, LLC
Medical DeviceDec 28, 2022
HeartWare HVAD Pump Kit, REF 1103 recall — FDA Z-0745-2023
Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline…
Class IIFDA: OngoingHeartware, Inc.
Medical DeviceDec 28, 2022
Fresenius Medical Care Holdings 2008T and 2008TBluestar Hemodialysis Machines with recall — FDA Z-0734-2023
(1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, has been identified as the UI-MICs Board is sensitive to Electromagnetic Interference (EMI)…
Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.