95,083 total recalls in our database
OptumHealth Care Solutions
Nimbus II Plus, Infusion Pump Systems, manufactured by InfuTronix, are being removed the from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, high or low flow rate, or damaged pump housing.
Jiangsu Shenli Medical Production Co.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Fresenius Medical Care Holdings
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Jiangsu Shenli Medical Production Co.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Philips North America
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Jiangsu Shenli Medical Production Co.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
Jiangsu Shenli Medical Production Co.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Cadwell Industries
There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potential unintended shock to the patient.
Philips North America
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Jiangsu Shenli Medical Production Co.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Jiangsu Shenli Medical Production Co.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Jiangsu Shenli Medical Production Co.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Jiangsu Shenli Medical Production Co.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Jiangsu Shenli Medical Production Co.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Jiangsu Shenli Medical Production Co.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Tornier S.A.S.
The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible and do not have regulatory approval.
Jiangsu Shenli Medical Production Co.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Jiangsu Shenli Medical Production Co.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Jiangsu Shenli Medical Production Co.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).