FDA Alerts Resource

The FDA serves the public by issuing recalls and alerts in order to provide necessary information for the public and to hopefully avoid injury, illness or even death. From the beginning of 2005 until today, the FDA has issued several alerts, and each of them is described below.

2006

Unpredictable Events in Medical Equipment due to New Daylight Saving Time Change

The adjusted daylight savings time schedule carried the possibility of malfunctioning technological equipment.

Custom Ultrasonics, Inc. Endoscope Washer/Disinfectors

The company agreed to stop marketing this product because it did not meet FDA specifications and regulations.

Precautions in Using the Reintroduced Vapotherm® 2000i [Respiratory Gas Humidifier] System

This device had been previously recalled, but was allowed to be released once again with several cautionary recommendations.

Reprocessing of Reusable Ultrasound Transducer Assemblies

The FDA reminded the public to properly clean these instruments before performing biopsies.

Oxygen Regulator Fires

Incorrectly using seals led to dangerous fires.

Fungal Keratitis Infections Related to Contact Lens Use

The manufacturer pulled this product from the market.

Gambro Prisma® Update

Additional injuries were reported with this update.

Cochlear Implants

Bacterial meningitis became a risk for children with cochlear implants.

2005

Guidant III

The FDA updated its earlier alerts due to the recording of additional injuries.

Risk of Electromagnetic Interference with Medical Telemetry Systems

This alert concerned the frequency at which these devices operated and the potential for interference.

Ventak Update

The above alert was amended three months later because it was found that additional patients had suffered injuries as a result of using this device.

Gambro Prisma® Continuous Renal Replacement System

Failure to properly respond to an “incorrect weight” message from the device could lead to serious injuries or death.

Complications from Metallic Tracheal Stents in Patients with Benign Airway Disorders

Patients without serious airway disorders were found to be at risk by using metal stents.

Guidant VENTAK PRIZM® 2 DR and CONTAK RENEWAL® Implantable Cardioverter Defibrillators

This alert was a separate issue from the recalls associated with Guidant.

MRI-Caused Injuries in Patients with Implanted Neurological Stimulators

Patients who have implanted neurological stimulators can suffer serious injuries if they receive an MRI.

Vail Products Enclosed Bed Systems

Vail stopped manufacturing these enclosed beds because users were becoming trapped inside of the beds, leading to suffocation and even death.

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