May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL or Pulse Oximetry (SpO2) under certain conditions.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Sterile Co-Flex Med 4" - Product Usage: Single Use secondary wound dressing or compression wrap
Andover Healthcare
Class I - Dangerous
Incomplete packaging seal of sterile product
OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement.
OMNIlife science
Class I - Dangerous
Stems missing porous coating on the device.
MotoBand CP, Poly-axial Locking Screw, 3.0mm x 28mm
CrossRoads Extremity Systems
Class I - Dangerous
Potentially includes a 3.0mm x 30mm screw instead of 3.0mm x 28mm screw.
Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound dressing or compression wrap
Andover Healthcare
Class I - Dangerous
Incomplete packaging seal of sterile product
Class I - Dangerous
The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize screw-in or threaded interface type DCD modules
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class I - Dangerous
The sterile barrier of some devices may have been affected
Class I - Dangerous
The sterile barrier of some devices may have been affected
Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.
Class I - Dangerous
The sterile barrier of some devices may have been affected
Class I - Dangerous
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class I - Dangerous
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class I - Dangerous
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class I - Dangerous
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class I - Dangerous
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class I - Dangerous
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class I - Dangerous
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class I - Dangerous
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervical aspiration of the uterine cavity. Part# 54298-10/pack
Olympus Corporation of the Americas
Class I - Dangerous
Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could separate