Class I - Dangerous
Microcatheter may have circumferential defects (cracks) along its shaft.
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Surgical Instruments
🏥 Medical Devices • 7,015 recalls
These custom sterile surgical kits contain the component, ECOLAB ORS Fluid Warming and Slush Drape, which was recalled due to the possibility that the sterile packaging may contain small channels in the seal of the pouch.
Class I - Dangerous
Certain lots of the Application Instrument for Sternal ZIPFIX that were previously recalled on August 19, 2015 and subsequently repaired and returned to customers between August 26, 2015 and September 23, 2015. The screws on the repaired instruments have the potential to break or loosen. DePuy Synthes is requesting the return of the repaired device in exchange for a new device.
During a review of the IFU of the SilverStat Pads, it was found that the IFU did not match that submitted in the original 510k
Class I - Dangerous
Instances of data sets not being accurately registered to the patient anatomy were observed.
Class I - Dangerous
The IFU of the Neptune Plus Pads, does not match that submitted in the original 510k. Need to remove: for haemostasis following needle/sheath removal
Class I - Dangerous
It was reported that packaging was not properly sealed.
Class I - Dangerous
Cook Medical has received six product complaints associated with reports of the 2.6FR curved catheter being mixed with the 4.0FR straight catheter and vice versa. Investigation revealed the products were mixed during processing.
Medtronic has discovered that select lots of the Amphirion Deep PTA Balloon Dilation Catheter have a potential breach in the pouch seal enclosing the sterilized product.
Class I - Dangerous
The products have been identified to have incorrect size prints on the MILEX PESSARY KIT packaging. While the Pessary pouch is marked with correct size, an incorrect label on the packaging does not meet the required release specification.
Class I - Dangerous
Utah Medical is conducting a recall of Myelo-Nate CSF Sampling Kit due to an internal post-sterilization inspection that found a sterile finished tray where the seal between the Tyvek lid and the PETG tray on one side of the tray had been compromised.
MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: Model M0001SS
GE Medical Systems
Class I - Dangerous
GE became aware of an issue with the table transfer release mechanism of the MR Surgical Suite Option. The issue may prevent patient transfer between the MR and surgical tables.
Class I - Dangerous
User settings were no longer on the monitor's memory after these systems were powered off and back on.
Class I - Dangerous
The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified non-latex gloves.
A defect occurred in the production process of Helioseal F Sealant; the particles in the faulty component seem to be larger than the size defined in the formula. This results in difficulties during extrusion of the material.
Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use during a surgical procedure.
Resource Optimization & Innovation
Class I - Dangerous
The kits contain pressure monitoring kits or sets which are being recalled as a result of flow restriction issues in the trifurcated IV set.
Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units
C.R. Bard
Class I - Dangerous
Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 French. The unit label (catheter package) may state Product Code 63516 and Catheter Size 16 French.
Class I - Dangerous
CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues.
Class I - Dangerous
The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of the inserter was undersized.
64 units of Achieve Electrical Cables were shipped with a potential sterility breach.