Complete FDA and NHTSA recall records dated in May 2020.
These records include useful source details for the selected month.
Inability for the guidewire to pass through the needles included with the catheter kits.
Ambulance Cots may not meet crash test standard BS EN 1789
Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. If the system displays the error message Err 16305…
Inability for the guidewire to pass through the needles included with the catheter kits.
Inability for the guidewire to pass through the needles included with the catheter kits.
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an…
Failure to prime due to an assembly error
It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail.
After feedback from customers and internal suspicion, Handicare has become aware that abnormal use of Eva-lifts could lead to a deterioation in the joint of the liftarm. This could lead to…
Inability for the guidewire to pass through the needles included with the catheter kits.
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an…
Inability for the guidewire to pass through the needles included with the catheter kits.
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an…
Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more…
There is potential for a white paper-type residue attached to the catheter.
The firm received complaints on five devices from one specific lot where the stent dislodged from the balloon delivery system prior to deployment. Use of affected product may lead to…
Failure to prime due to an assembly error
False positive reaction on the reagent.
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an…
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an…
Saline Flush Syringe compromised sterility due to holes in the packaging.
The firm received complaints that the EMPOWR Acetabular Impactor Balls were fracturing/cracking during impaction which could cause debris to migrate or be left in the joint space.
Saline Flush Syringe compromised sterility due to holes in the packaging.
When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or more electrical contacts could break due to pulling, twisting, or dropping of the connector. If…
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
