Dewei Medical Equipment is recalling DNA/RNA Preservation Kits because they were distributed to U.S. customers without FDA authorization, clearance, or approval.

Philips Respironics recalled certain BiPAP machines due to a plastic issue that may release certain chemicals of concern and cause device failure.

La nueva etiqueta del sistema endovascular AFX2 para AAA (AFX2) incluye información para informar mejor a los pacientes y a los profesionales de la salud sobre el riesgo de endofugas de tipo III.

New labeling for AFX2 Endovascular AAA System (AFX2) includes information to better inform patients and health care providers of the risk of Type III endoleaks

Do not routinely use AFX2 endovascular grafts for patients with abdominal aortic aneurysms.

The FDA posts letters to health care providers about the safe use of medical devices.

The FDA is issuing this update to inform the health care community of the final PAS results and updated labeling for the Impella RP System by Abiomed.

The FDA is updating information about Getinge’s Maquet/Datascope IABP devices including information about three voluntary recalls.

The FDA is alerting health care facilities and providers of a shortage of Getinge Maquet/Datascope Intra-Aortic Balloon Pump (IABP) devices, including limited supplies of IAB catheters, new Cardiosave IABPs, and Cardiosave IABP parts.

Lenoir, North Carolina. Exela Pharma Sciences, LLC, (Exela) is expanding their recall, adding fourteen (14) lots to the ongoing voluntary recall of forty-nine (49) lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20-count carton. A total of 63 lots are now being recalled to the c

The WatchCare IMS includes hospital beds and disposable incontinence pads. Radiofrequency emissions from the system may interfere with other medical devices.

FDA is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with the osteoporosis medicine Prolia (denosumab).

ACTUALIZACIÓN: Se retiran del mercado ciertos ventiladores, máquinas BiPAP y máquinas CPAP de Philips Respironics debido a posibles riesgos para la salud: Comunicado de seguridad de la FDA

Find answers to frequently asked questions on Philips Respironics ventilators, BiPAP, and CPAP machines recall

This update provides additional information on the recall and recommendations for people who use repaired and replaced devices.

The FDA recommends repeat testing following a negative result to reduce the risk that a COVID-19 infection could be missed, whether or not you have symptoms.

Omnipod DASH Insulin Management System’s Personal Diabetes Manager may have battery issues including swelling, fluid leakage, and extreme overheating.

Omnipod DASH Insulin Management System’s Personal Diabetes Manager may have battery issues including swelling, fluid leakage, and extreme overheating.

Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), today announced a Medical Device Correction for the Omnipod® 5 Automated Insulin Delivery System because of an issue with the Omnipod 5 Controller charging port and cable. This does not impact the Omnipod 5 Pod, the Omnipod® DASH Insulin M

La FDA está informando a los pacientes y proveedores de atención médica de que los oxímetros de pulso tienen limitaciones y un riesgo de inexactitud que debe tenerse en cuenta.