Complete FDA and NHTSA recall records dated in May 2024.
These records include useful source details for the selected month.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
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…
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
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…
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
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.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
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…
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory…
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…
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show the points to be off from the physical reference point of the pointer or suction.
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…
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
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.
