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).

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.

Thornton, Colorado, Adam’s Polishes, LLC is voluntarily recalling lot 133475 of Adam’s Polishes Hand Sanitizer to the consumer level. FDA testing has found this lot to contain undeclared methanol. Adam’s Polishes is recalling 19 other lots in an abundance of caution. Persons who accidently ingest (

Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), announced on October 17, 2022, a Medical Device Correction for all Omnipod DASH® Personal Diabetes Managers (PDMs) distributed globally. This action was taken voluntarily with the knowledge of the FDA and other regulatory agencies.

Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, has announced a worldwide recall of affected lots of the below-referenced Gibeck® Iso-Gard® Filter products. The Gibeck® Iso-Gard® Filter is a bacterial and viral filter, intended for

Listing of Medical Device 2022 Safety Communications

The FDA recommends that parents, caregivers, and health care providers not to use infant head shaping pillows to prevent or treat any medical condition.

The Iso-Gard Filter S is a breathing circuit bacterial filter. It may split or detach preventing patients from getting sufficient supply of air.

Comunicado de seguridad de la FDA: reutilice las cánulas de traqueostomía o cambie a alternativas adecuadas durante su escasez

The FDA recommends health care providers discuss alternatives for MRI-guided breast biopsies with patients due to shortage of Philips Invivo plates and disposables.

The FDA recommends using the following strategies to reduce the number of tracheostomy tubes used per patient during the shortage.

The FDA is evaluating the potential risk of exposure to toxic compounds when using certain Fresenius Medical Care hemodialysis machines

Mylan Institutional LLC, a Viatris company, is voluntarily recalling lot AJ21002, exp 3/2024, of Octreotide Acetate Injection, 500 mcg/mL, packaged in a carton of ten 1mL syringes. This lot is being recalled at the user (hospital/pharmacy) level due to a product complaint of the presence of glass pa

Do not to use the recalled Mighty Bliss electric heating pads due to the risks of injury, including electric shocks, skin burns, rashes or irritation.