There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.
All Recalls
95,038 total recalls in our database
Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability
NEONATAL PICC INSERTION TRAY Kit Code: CVI2310 - Product Usage: Kit is used for Peripheral Central Line Insertion procedures on newborns.
Centurion Medical Products
🏥 Medical Devices Class I - Dangerous
Potential for sterile packaging to be compromised
LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used for Left Ventricular Assist Device Dressing System for general patient population.
Centurion Medical Products
🏥 Medical Devices Class I - Dangerous
Potential for sterile packaging to be compromised
🏥 Medical Devices Class I - Dangerous
There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.
🏥 Medical Devices Class I - Dangerous
Negative Bias with Lot EA9227.
Lasers/Catheters did not calibrate during set-up prior to use.
HIGH DRAINAGE LVAD TRAY Kit Code: DM950 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
Centurion Medical Products
🏥 Medical Devices Class I - Dangerous
Potential for sterile packaging to be compromised
Workstation, G2, Configured (P/N 000-0241)
Intellijoint Surgical
🏥 Medical Devices Class I - Dangerous
Apple has determined that, in a limited number of older generation 15-inch MacBook Pro Units, the battery may overheat and pose a fire safety risk. To date, Intellijoint has distributed, 15-inch MacBook Pros which are the Workstation component (affected P/N 000-0241) in the Intellijoint HIP System.
VITROS 4600 Chemistry System, clinical chemistry analyzer
Ortho Clinical Diagnostics
🏥 Medical Devices Class I - Dangerous
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Logolas Laser Projection Series
Gk Photonics
🏥 Medical Devices Class I - Dangerous
The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could unintentionally expose the user and/or observers to high power laser radiation. It needs to be replaced for safety reasons.
🏥 Medical Devices Class I - Dangerous
There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738
St Jude Medical
🏥 Medical Devices Class I - Dangerous
Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.
🏥 Medical Devices Class I - Dangerous
Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
🏥 Medical Devices Class I - Dangerous
When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.
🏥 Medical Devices Class I - Dangerous
There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615
St Jude Medical
🏥 Medical Devices Class I - Dangerous
Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.
🏥 Medical Devices Class I - Dangerous
Salivary assay may observe a higher percentage of samples with 0 pg/ml testosterone or results which are too low. Saliva samples in the low measuring range of the kit(< 50 pg/ml) were assayed significantly lower
iCT SP Model # 728311, computed tomography x-ray system
Philips Medical Systems (Cleveland)
🏥 Medical Devices Class I - Dangerous
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423 Product Usage: An aid for introducing a hemodialysis catheter
Medical Components, Inc
🏥 Medical Devices Class I - Dangerous
Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.