The FDA is evaluating the potential for exposure to airborne chemicals (formaldehyde, cyclohexanone, and other volatile chemicals) from neonatal incubators
Sacramento, CA, VitalityVita.com is voluntarily recalling lot 230811, Exp 8/11/25, of VitalityXtra Capsules and PeakMax Capsules packaged in 10-count blisters in a cardboard carton
Sacramento, CA, Boulla LLC is voluntarily recalling lot YZM240406, Exp 04/05/27, of ZoomMax Capsules and ZapMax Casules packaged in 10-count blisters in a cardboard carton to the
2024 Medical Device Recalls
IPV Phasitron 5 breathing circuits help provide therapy to promote ventilation. Certain devices may expose patients to high levels of nickel
The heater door of Giraffe Omnibed, CareStation infant incubators/ warmers may fall off if instructions are not followed, potentially injuring patients
The FDA posts letters to health care providers about the safe use of medical devices
The recommendations for EVair Compressor use have been updated by GE HealthCare
These air compressor devices’ instructions for use have been updated by GE HealthCare.
Tracheostomy Tube Recall: Smiths Medical Removes BLUselect, BLUgriggs, and BLUperc Tracheostomy Tube Kits due to Potential Disconnection of Pilot Balloon
BLUselect tracheostomy tubes are used for artificial airways. Some lots may have an issue where the pilot balloon disconnects
Listing of Medical Device 2024 Safety Communications
The FDA’s updated information about BioZorb Marker
Jaco assistive robotic arms are used when people have little or no arm mobility but a damaged arm contacting part of the wheelchair is a fire hazard
Hologic, Inc. is recalling BioZorb Marker due to complications and adverse events with implanted devices
These vascular embolization devices’ instructions for use have been updated by Boston Scientific
Medtronic plc (NYSE: MDT), a global leader in healthcare technology, voluntarily issued a field action starting on July 31, 2024, notifying global customers of its MiniMed™ 600
MiniMed pumps deliver insulin to people with diabetes who need it. Wiring damage from impacts may cause the battery to drain faster than expected.
Staska Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL Due to the Presence of Glass Particles
Bennet, NE, STASKA PHARMACEUTICALS, INC. is voluntarily recalling 1 lot of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL, 50mL vials to the user
10/8/24 – National City, CA, C&A Naturistics is voluntarily recalling all lots of AK Forte, 400 mg tablets, to the consumer level. FDA analysis has found the product to be
The FDA issues alert about risk of false results with Cue Health’s COVID-19 Tests due to modifications made without FDA authorization that have a strong likelihood to impact