All Recalls

Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).

Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.

Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.

Detachment controller, of an aneurysm embolization system, has an out of specification tunnel opening dimension, which may prevent the implant device pusher from being fully inserted into the controller, which may result in the inability of the controller to properly detach the implant device, which could cause delays and excessive manipulation that may cause the implant to move and damage vessels

Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.

Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.

There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.

Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.

Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant. Firm root cause investigation confirmed that label detachment is due to an adhesive change by a tier 2 supplier.

Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.

During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and preventing the needle tip from being in the safely shielded (leaving the needle tip exposed).

Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).

Unable to charge the battery pack- battery packs will allow the batteries to be charged if the voltage of any cell is below 2.5V. When this occurs, the battery pack will not accept the charge, could vent and possibly catch fire

Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.

Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair

Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.

Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.

Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).

the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.

the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.