Mighty Bliss electric heating pads are being recalled because they may cause injuries including electric shocks, burns, rashes and irritation.

Batteries on the Arrow AutoCAT 2 and AC3 Intra-Aortic Balloon Pumps deplete faster than expected, which may cause the pump to stop during patient transport.

An inadequate connection between housings in Arrow multi-lumen central venous access and catheter kits may cause a cross lumen leak that can harm patients.

Detect, Inc. is voluntarily recalling specific lots of the Detect Covid-19 Test™, our molecular, over-the-counter test used to identify SARS-CoV-2 (the virus that causes Covid-19) in self-collected nasal swabs. The recall affects a total of 11,102 tests shipped to customers from July 26th, 2022 thro

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

Thermo Scientific Gram Negative IVD AST Sensititre Plate is being recalled for a risk of potential false susceptible results when tested with certain antibiotics.

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