Complete FDA and NHTSA recall records dated in 2024, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
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).
Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
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…
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…
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…
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…
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).
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).
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
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).
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).
Potential contamination with Listeria Monocytogenes
FDA inspection and investigation of firm's website and social media pages found that Sammy's online marketing materials included misleading information that implied the product was safe for…
undeclared allergens (egg)
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.
