MedWatch Safety Alerts

Evaluation of Airborne Chemicals from Neonatal Incubators - Letter to Health Care Providers

The FDA is evaluating the potential for exposure to airborne chemicals (formaldehyde, cyclohexanone, and other volatile chemicals) from neonatal incubators

VitalityVita Issues Voluntary Nationwide Recall of VitalityXtra and PeakMax Capsules Due to the Presence of Undeclared Sildenafil and Diclofenac

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

Boulla LLC Issues Voluntary Nationwide Recall of ZoomMax and ZapMax Capsules Due to the Presence of Undeclared Sildenafil and Diclofenac

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

2024 Medical Device Recalls

IPV Therapy Device Recall: Percussionaire Removes Certain Phasitron 5 Breathing Circuits Due to Risk of Nickel Exposure

IPV Phasitron 5 breathing circuits help provide therapy to promote ventilation. Certain devices may expose patients to high levels of nickel

Incubator/Warmer Correction: GE Healthcare Updates Use Instructions for Giraffe OmniBed and Giraffe Omnibed CareStation due to Risk of Heater Door Falling and Causing Infant Injury

The heater door of Giraffe Omnibed, CareStation infant incubators/ warmers may fall off if instructions are not followed, potentially injuring patients

2024 Letters to Health Care Providers

The FDA posts letters to health care providers about the safe use of medical devices

Update: Use of GE HealthCare EVair and EVair 03 Compressors - Letter to Health Care Providers

The recommendations for EVair Compressor use have been updated by GE HealthCare

Air Compressor Device Correction: GE HealthCare Provides Updates to EVair Compressors Due to Final Formaldehyde Testing Results

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

2024 Safety Communications

Listing of Medical Device 2024 Safety Communications

Update: Do Not Use BioZorb Marker Implantable Radiographic Marker Devices: FDA Safety Communication

The FDA’s updated information about BioZorb Marker

Assistive Arm Correction: Kinova Issues Correction for Jaco Assistive Robotic Arm due to Fire Hazard and Burn Risk

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. Recalls BioZorb Marker Due to Complications with Implanted Devices

Hologic, Inc. is recalling BioZorb Marker due to complications and adverse events with implanted devices

Vascular Embolization Device Correction: Boston Scientific Updates Use Instructions for Obsidio Conformable Embolic for Increased Ischemia Risk When Used for GI Bleeding

These vascular embolization devices’ instructions for use have been updated by Boston Scientific

Voluntary Recall Notifying Medtronic Insulin Pump Users of Potential Risks of Shortened Pump Battery Life

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

Insulin Pump Recall: Medtronic Notifies Users of MiniMed 600 and 700 Series Pumps of Risk of Shorter than Expected Battery Life

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

C&A Naturistics Issues Voluntary Nationwide Recall of AK Forte Tablets con Ortiga y Omega 3 Due to the Presence of Undeclared Drug Ingredients: Diclofenac, Dexamethasone, and Methocarbamol

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

UPDATE: Do Not Use Cue Health’s COVID-19 Tests Due to Risk of False Results: FDA Safety Communication

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

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