Max Mobility/Permobil has initiated a nationwide recall of the Speed Control Dial component used with the SmartDrive MX2+ Power Assist Device due to potential safety and performance concerns.

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

The FDA issued an update on the recommendations about the potential for exposure to airborne chemicals from neonatal incubators.

HemoPro EVH Systems have updated instructions related to bent/detached heater wires and peeling/detaching silicone during minimally invasive surgery.

Philips Monitoring Service Application processes mobile cardiac telemetry data but failed to send critical data for review by healthcare professionals.

FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy: FDA Safety Communication

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Astellas Pharma US, Inc. (Head of US Commercial: Michael Petroutsas, "Astellas") is voluntarily recalling one lot of PROGRAF® 0.5mg (tacrolimus) and one lot of ASTAGRAF XL® 0.5mg (tacrolimus extended-release) capsules to the consumer level. These products are being recalled because bottles may conta

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Fort Worth, Texas. Alcon Laboratories is voluntarily recalling one (1) lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101) to the consumer level. Alcon evaluated a consumer complaint of foreign material observed inside a sealed single use vial and determined th

Some CSB batteries intended for use with Plum 360, A+ or A+3 infusion pumps may be counterfeit and are not validated for use in these pumps.

Endo, Inc (OTCQX: NDOI) (“Endo”), announced today that one of its operating subsidiaries, Endo USA, Inc., is voluntarily recalling all lots within expiry of Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP) 30mg/30mL (1mg/mL) 30 mL vials, to the consumer level. This product, which pre-d

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

December 16, 2024 – Los Angeles, California - Shoppers-Plaza is voluntarily recalling all lots of Fouzee Sugarlin Herbal Formula capsules to the consumer level. See Attachment 1 for photo of product labeling. Fouzee Sugarlin Herbal Formula capsules is an unapproved new drug for which safety and effi

POLARx Cryoablation Balloon Catheters treat atrial fibrillation. After reports of atrio-esophageal fistula, the use instructions are being updated.

BioZorb Markers are implantable and used to mark soft tissue for procedures. They are being recalled after reports of patient complications.

The FDA is warning that Veozah (fezolinetant), a medicine used to treat hot flashes due to menopause, can cause rare but serious liver injury. If there are signs and symptoms suggesting liver injury, stopping the medicine could prevent worsening liver injury.

Read the FDA’s recommendations related to Accolade pacemaker devices by Boston Scientific and a potential need for early device replacement.