🏥 Medical Devices • 6,839 recalls
LeMaitre Vascular
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
LeMaitre Vascular
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
LeMaitre Vascular
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
LeMaitre Vascular
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Microcatheter may have circumferential defects (cracks) along its shaft.
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.
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
Instances of data sets not being accurately registered to the patient anatomy were observed.
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
It was reported that packaging was not properly sealed.
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.
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.
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.
GE Medical Systems
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.
User settings were no longer on the monitor's memory after these systems were powered off and back on.
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.
Resource Optimization & Innovation
The kits contain pressure monitoring kits or sets which are being recalled as a result of flow restriction issues in the trifurcated IV set.