Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
Radiometer Medical ApS
Class I - Dangerous
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
Class I - Dangerous
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.
Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies.
Abbott Laboratories Inc. (St Jude Medical)
Class I - Dangerous
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Class I - Dangerous
Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa.
Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld
ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve 8.8, Refractive Power -1.50
Johnson & Johnson Vision Care
Class I - Dangerous
Potential that a limited number of individual contact lens packages have an incomplete packaging seal.
Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Class I - Dangerous
The component part numbers intended for shipment to a third-party, where they are further processed into kits and sterilized were instead shipped directly to customers.
Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54 mm, Rx Only, Non-Sterile, UDI: (01)00190376268583
Alphatec Spine
Class I - Dangerous
There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
Class I - Dangerous
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach of the package integrity. A breach of package integrity may contaminate other components in AVID Medical kits.
(1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal opening of the delivery sleeve and tissue/debris within the surgical.field to prevent complete occlusion. Some surgical approaches (e.g., endonasal) may increase this potential. {f unintended reduction in light output occurs and/or occlusion of the sleeve is suspected, both the delivery sleeve and the fiber should be replaced (2) Removal for the LX Light Source potential for the distal tip of the sleeve/fiber assembly potential to burn healthy tissue resulting in minor to moderate injury to the patient or end user.
Quanta System Sterile Optical Laser Fiber, reusable
Quanta System, S.p.A.
Class I - Dangerous
Product sterility is potentially compromised.
Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48 mm, Rx Only, Non-Sterile, UDI: (01)00190376268521
Alphatec Spine
Class I - Dangerous
There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.