MedWatch Safety Alerts
Max Mobility / Permobil Issues Nationwide Recall of SmartDrive Speed Control Dial Due to the Motor Being Unresponsive to the User
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
Neonatal Incubator Correction: GE HealthCare Updates Use Instructions for GE HealthCare Giraffe OmniBed Carestation and Incubator Carestation due to Risk of Patient Formaldehyde Exposure
Newly manufactured Giraffe Omnibed and Incubator Carestations for neonates may put off higher than expected formaldehyde levels for the first week of use
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
Update: Evaluation of Airborne Chemicals from Neonatal Incubators - Letter to Health Care Providers
The FDA issued an update on the recommendations about the potential for exposure to airborne chemicals from 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
HemoPro EVH Systems have updated instructions related to bent/detached heater wires and peeling/detaching silicone during minimally invasive surgery
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
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
FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy: FDA Safety Communication
2024 Medical Device Recalls
The FDA posts information about certain medical device recalls and early alerts to help increase awareness of these issues
Early Alert: Solution Set Issue from Baxter Healthcare Corporation
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Early Alert: Fluid Delivery Set Issue from Medline
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Early Alert: Extracorporeal Blood Circuit Issue from Nuwellis
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Astellas Pharma US, Inc. Issues Voluntary Nationwide Recall of One Lot of PROGRAF® 0.5mg (Tacrolimus) and One Lot of ASTAGRAF XL® 0.5mg (Tacrolimus Extended-Release Capsules) Because Bottles Shipped to U.S. May Contain Empty Capsules
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 (
Alcon Laboratories Issues Voluntary Nationwide Recall of One (1) Lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101), Due to Fungal Contamination
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
Early Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Early Alert: Nephroscope Sheath Issue from Trokamed GmbH
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
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
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 USA, Inc. Issues Voluntary, Nationwide Recall of Adrenalin® Chloride Solution (EPINEPHrine Nasal Solution, USP) Due to the Potential for Administration Errors
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
Hologic, Inc. Recalls BioZorb Marker Due to Complications with Implanted Devices
Hologic, Inc. is recalling BioZorb Marker due to complications and adverse events with implanted devices
Shoppers-Plaza Issues Voluntary Nationwide Recall of Fouzee Sugarlin Herbal Formula Due To Presence Of Undeclared Metformin And Glyburide
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
Update: Do Not Use BioZorb Marker Implantable Radiographic Marker Devices: FDA Safety Communication
The FDA’s updated information about BioZorb Marker
