Summary Company Announcement Date: January 24, 2025 FDA Publish Date: January 24, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety – Potential Foreign Material Company Name: Provepharm Inc. Brand Name: Brand Name(s) Provepharm Inc. Product Description: Product Description Phenylephrine hydrochloride Injection, USP, 10 mg/ mL Company Announcement FOR IMMEDIATE…
Copaxone, Glatopa (glatiramer acetate): Drug Safety Communication – FDA Adds Boxed Warning About a Rare but Serious Allergic Reaction Called Anaphylaxis
[Posted 01/22/2025] AUDIENCE: Patient, Caregiver, Health Care Professional, Pharmacy, Neurology ISSUE: The FDA is warning about the risk of a rare but serious allergic reaction with the medicine glatiramer acetate (Copaxone, Glatopa), which is used to treat patients with multiple sclerosis (MS). This serious allergic reaction, called anaphylaxis, can occur at any time while on…
Max Mobility / Permobil Issues Nationwide Recall of SmartDrive Speed Control Dial Due to the Motor Being Unresponsive to the User
Summary Company Announcement Date: January 14, 2025 FDA Publish Date: January 17, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Due to potential safety and performance concerns. Company Name: Max Mobility, LLC. Brand Name: Brand Name(s) Max Mobility/Permobil Product Description: Product Description Speed Control Dial Component Company Announcement Reason for Voluntary Field…
Early Alert: Infusion Pump Software Issue from Fresenius Kabi USA
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Fresenius Kabi USA has…
Update: Evaluation of Airborne Chemicals from Neonatal Incubators – Letter to Health Care Providers
January 16, 2025 The U.S. Food and Drug Administration (FDA) is providing an update on its evaluation of the potential for exposure to airborne chemicals that may be released from neonatal incubators. Based on the FDA’s review of the totality of the available information including testing data, we have determined that all new neonatal incubators…
Endoscopic Vessel Harvesting (EVH) System Correction: Getinge and Maquet Cardiovascular Update Use Instructions for VasoView HemoPro 2 (VH-4000 and VH-4001) EVH Systems due to Risk for Bent or Detached Heater Wires and Silicone Peeling or Detaching During Use
The devices described in this recall are included in the related Letter to Health Care Providers. See the Letter to Health Care Providers for the most current information on these devices. This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. The FDA has…
Outpatient Telemetry Correction: Philips Issues Correction for Monitoring Service Application used with Mobile Cardiac Outpatient Telemetry Due to Potential for Missed Information or Notifications That May Impact Patient Care Impact
This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction. Affected Product Product Names: Monitoring Service Application for Mobile…
FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy: FDA Safety Communication
[Posted 1/7/2025] AUDIENCE: Patient, Health Care Professional, Pharmacy, Immunology, Pulmonology ISSUE: FDA has required and approved safety labeling changes to the Prescribing Information for Abrysvo (Respiratory Syncytial Virus Vaccine) manufactured by Pfizer Inc. and Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) manufactured by GlaxoSmithKline Biologicals. Specifically, FDA has required each manufacturer to include a new warning…
Infusion Pump Battery Recall: ICU Medical Removes Some CSB Batteries Intended For Use With Plum 360, A+, and A+3 Infusion Systems Due to Reports of Allegedly Counterfeit, Untested Batteries In Use
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product and Allegedly Counterfeit Product Product Names: Batteries for use in Plum 360, Plum A+, and…
Early Alert: Fluid Delivery Set Issue from Medline
99000069 FDS, 135, CHMN, W/F, MLL, RC(2), PG 0000128741 10193489069587 30193489069581 99000069 FDS, 135, CHMN, W/F, MLL, RC(2), PG 0000134505 10193489069587 30193489069581 99000069 FDS, 135, CHMN, W/F, MLL, RC(2), PG 0000133893 10193489069587 30193489069581 99000069 FDS, 135, CHMN, W/F, MLL, RC(2), PG 0000135769 10193489069587 30193489069581 99000069 FDS, 135, CHMN, W/F, MLL, RC(2), PG 0000139596 10193489069587 30193489069581…