On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated aging study conducted as part of a new market submission. The study found that one of 60 Dissector units that underwent 3 year accelerated aging failed the dye penetration test indicating that the seal on sterile packaging was compromised. The dissector products are labeled with a 3 year shelf life.
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Surgical Instruments
🏥 Medical Devices • 7,015 recalls
Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and MMT-332A (3.0mL) used with Medtronic Paradigm insulin pumps because they may have increased risk for leaking. A leak in the reservoir may result in delivery of less insulin than intended. In addition, if there is a leaky reservoir and an insulin blockage occurs in the infusion set, the pump may not
Class I - Dangerous
The firm initiated this recall of one lot (121402) of nanoPOINT Injectors after they noticed that Tyvek lids might have been damaged and, therefore, the stability of the sterile barrier might be negatively affected.
Class I - Dangerous
Individual component's IFUs are not included with the kit.
Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.
Arrow International
Class I - Dangerous
Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen.
StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.
Medtronic Navigation
Class I - Dangerous
Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5.4 which can be used on Medtronic Navigation StealthStation 57 and i7 systems or a Medtronic Planning Station due to the potential of discrepancy between the exam image and the displayed measurement or overlay under certain conditions of use.
Class I - Dangerous
The firm will recall and replace the identified instrument trays in the field, with trays that have improved labeling, including lids that contain the statement indicating 'PREVACUUM ONLY"
Non-toxic inks, used on the silk screen graphics of the case bases and lids, and caddy lids, were found to be either delaminating or running off from the substrate after repeated washing and sterilization cycles.
Edwards Lifesciences is recalling certain lots of the EndoReturn Arterial Cannula that were built with an incorrect component. This component can create a performance problem with the IntraClude IntraAortic Occlusion device.
Class I - Dangerous
This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.
Device design.
Class I - Dangerous
This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.
Class I - Dangerous
This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.
This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.
Class I - Dangerous
This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.
Class I - Dangerous
PDC Healthcare initiated this recall of Non-Sterile Viscot Part Number 1437-100 Surgical Skin Markers, becuase they were inadvertently mislabeled as PN STER-VIS Sterile Skin Marker Pen with Labels and Flex Ruter.
Class I - Dangerous
This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.
Class I - Dangerous
This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.
Correction to provide clarification and additional labeling to minimize likelihood on implanting filter backwards.
Class I - Dangerous
This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.