Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035A; 2) L...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound e...
Potential packaging failures, which could lead to a breach in the sterile barrier.
Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM18...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Convenience Kits: 1) OR ARTERIOGRAM, Model Number: CDS985094F; 2) KIT...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, ...
Potential packaging failures, which could lead to a breach in the sterile barrier.
Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) ...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS9830...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Convenience Kits: 1) DENTAL PACK, Model Number: DYNDA3003
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM103...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Estrone RIA, REF: DSL8700
The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some (very rare) cases may the issue occur.
Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used fo...
An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.
Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip
Firm is initiating a removal due to continued reports of adverse events.
Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31...
Potential packaging failures, which could lead to a breach in the sterile barrier.
Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip
Firm is initiating a removal due to continued reports of adverse events.
Medline Convenience Kits: 1) CHEST/BREAST-LF, Model Number: DYNJ83950
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip
Firm is initiating a removal due to continued reports of adverse events.
Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflat...
Issue with software algorithm which may lead to overpressure events.
Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 U...
Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.