Class I - Dangerous
Customer complaints were received of power to the unit ceasing and the display going blank.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Class I - Dangerous
The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.
CareFusion Vital Signs LightWand Stylet. A device inserted into an endotracheal tube to aid in the intubation procedure.
Vital Signs Colorado
Class I - Dangerous
Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3910 and 3960 due to a potential patient safety risk involving a breach in the sterile packaging that may not be recognized prior to use.
GA Industries is recalling the Logicon Caries Detector, version 5.0, for Carestream Dental because it was not submitted for approval to the FDA prior to product release.
Class I - Dangerous
Potential for device malfunction resulting in flow when the device should not be flowing
Class I - Dangerous
Device software treatment preset parameters for the XC treatment handpiece do not match the Operator Manual, and exceed recommended settings. Operator Manual parameters are lower than indicated for specific hair color and Fitzpatrick skin type resulting in insufficient treatment effect. May result in patient burns and hypopigmentation.
4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and BN-3083CV Accessory device used to administer medical fluids
Churchill Medical Systems
Class I - Dangerous
Potential for leaking caused by insufficient bond between needleless device and female luer.
Class I - Dangerous
Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/ Alpine) due to the supplier withdrawing it from the market for component updates or reconfiguration.
CROSSCHECK(R) Plating system, MTP NX Plate, Left, Recon, REF CCP-MPN2L. Orthopedic use.
Wright Medical Technology
Class I - Dangerous
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Left, REF CCP-LPX1L. Orthopedic use.
Wright Medical Technology
Class I - Dangerous
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
Class I - Dangerous
Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation.
4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to administer medical fluids
Churchill Medical Systems
Class I - Dangerous
Potential for leaking caused by insufficient bond between needleless device and female luer.
CROSSCHECK(R) Plating system, MTP CX Plate, Right, REF CCP-MPX1R. Orthopedic use.
Wright Medical Technology
Class I - Dangerous
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.
Siemens Healthcare Diagnostics
Class I - Dangerous
Siemens internal investigation confirmed that current contamination avoidance settings do not prevent carryover resulting in falsely elevated ADVIA Chemistry Lipase outlier results when running with Triglycerides, Triglycerides_2, Triglycerides_c, Cholesterol concentrated, and DLDL reagents.
4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to administer medical fluids
Churchill Medical Systems
Class I - Dangerous
Potential for leaking caused by insufficient bond between needleless device and female luer.
CROSSCHECK(R) Plating system, Utility Plate, 5-Hole, REF CCP-UTN5. Orthopedic use.
Wright Medical Technology
Class I - Dangerous
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
CROSSCHECK(R) Plating system, MTP NX Plate, Right, Recon, REF CCP-MPN2R. Orthopedic use.
Wright Medical Technology
Class I - Dangerous
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Right, REF CCP-HSX1R. Orthopedic use.
Wright Medical Technology
Class I - Dangerous
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction.
6" Trifurcated set with Bionectors, Product Code: BN-944 Accessory device used to administer medical fluids
Churchill Medical Systems
Class I - Dangerous
Potential for leaking caused by insufficient bond between needleless device and female luer.
CROSSCHECK(R) Plating system, Utility Plate, 6-Hole, REF CCP-UTN6. Orthopedic use.
Wright Medical Technology
Class I - Dangerous
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction