30-12-2020
This update to the February 2020 safety communication provides information on the final guidance, Product Labeling for Laparoscopic Power...
The snaps can break or detach from the rompers, posing a choking, laceration and pinching hazards to children.
The snaps can break or detach from the suits, posing choking and laceration hazards to children.
29-12-2020
The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and...
04-05-2017
The car seat can disengage from the stroller’s frame, posing a fall hazard to infants.
03-05-2017
Tip splitting has the potential to lead to loss of device function. Tip separation may require medical intervention to retrieve a separated segment...
On April 22, 2017, ReFlow Medical initiated a lot-specific voluntary recall of the Wingman35 Crossing Catheters.
Minor and serious injuries, including two patient deaths, following procedures that involved the use of non-Medtronic instruments with Medtronic's...
02-05-2017
UPDATED 05/02/2017. Class I Recall. Potential for ventilator reset during normal operation, without an accompanying alarm.
The blower motor is not grounded, posing an electrical shock hazard to individuals servicing the units
The cord can break near the base of the massager and expose the wires.
01-05-2017
