Urgent Medical Device Recall: Getinge Vaporizers Pose Potential Health Risks
Urgent Medical Device Recall: Getinge Vaporizers Pose Potential Health Risks
Published: March 04, 2025
By: Garcia Family Medicine Team
At Garcia Family Medicine, we prioritize keeping our patients and community informed about important health and safety updates. Today, we’re sharing critical information about a recent medical device recall announced by the U.S. Food and Drug Administration (FDA) involving Getinge’s Vaporizer Sevoflurane Quick-Fil and Vaporizer Sevoflurane Maquet Filling. These devices, used in anesthesia systems, have been flagged for a serious issue that could affect both patients and healthcare providers.
What’s Happening?
Getinge, a medical equipment manufacturer, is recalling specific vaporizers used to deliver sevoflurane—a common anesthetic gas mixed with oxygen during surgeries. The FDA has classified this as a Class I recall, the most serious type, due to the potential for severe injury or even death. This recall expands on an earlier one from 2024, prompted by new concerns about the devices’ safety.
The problem stems from reports of discoloration and corrosion inside these vaporizers when used with certain brands of sevoflurane (produced by Piramal or Baxter). Over time, this sevoflurane can break down into hydrogen fluoride, a toxic chemical. If inhaled or touched, hydrogen fluoride could cause serious health issues, including:
Respiratory irritation or fluid buildup in the lungs (lung edema)
Skin blisters or wounds
Dangerously low calcium or magnesium levels in the blood
In extreme cases, death
Thankfully, no injuries or deaths have been reported so far, but the risks are significant enough to warrant immediate action.
Which Devices Are Affected?
The recall applies to the following vaporizers:
Product Names: Vaporizer Sevoflurane Quick-Fil and Vaporizer Sevoflurane Maquet Filling
Model Numbers:
Quick-Fil: 6682285
Maquet Filling: 6682282
Serial Numbers:
Quick-Fil: All units with serial numbers above 3761
Maquet Filling: Units from 17336–23784 and all above 1339
These devices are part of Getinge’s Flow anesthesia systems, commonly used in hospitals and surgical centers to administer general anesthesia.
Why Does This Matter to You?
While this recall primarily affects healthcare facilities, it’s important for patients and families to be aware—especially if you or a loved one has recently undergone surgery or is scheduled for one. Anesthesia safety is critical, and issues like this could impact the quality of care provided. At Garcia Family Medicine, we believe informed patients are empowered patients.
What’s Being Done?
Getinge issued an Urgent Medical Device Recall letter on January 15, 2025, instructing healthcare providers to:
Stop using affected vaporizers if they’ve been exposed to Piramal or Baxter sevoflurane.
Quarantine any suspect devices.
Avoid emptying vaporizers showing signs of discoloration, corrosion, or unusual odors—these should be handled with protective gear and stored safely.
For unaffected units, empty the sevoflurane and run a “dry run” process to clear out any residue (detailed instructions were provided in the recall letter).
Return affected devices to Getinge for replacement or further guidance.
Healthcare facilities are also asked to notify staff and other locations where these devices might have been transferred.
What Can You Do?
If you’re a patient:
Ask your healthcare provider or surgeon about the equipment used during any recent or upcoming procedures.
If you experience unusual symptoms after surgery—like breathing difficulties, skin irritation, or unexplained fatigue—contact your doctor immediately and mention this recall.
If you’re a healthcare professional:
Check your inventory for the affected vaporizers and follow Getinge’s recall instructions.
Report any issues to the FDA’s MedWatch program (details below).
How to Report Problems
The FDA encourages anyone—patients or providers—to report adverse reactions or device issues through MedWatch, their Safety Information and Adverse Event Reporting Program. You can file a report online at fda.gov/medwatch or call 1-800-FDA-1088.
Stay Informed
For more details, you can explore these FDA resources:
Questions about the recall? Contact Getinge’s Sales Support at CSalesSupport@getinge.com or reach out to your local Getinge representative.
Our Commitment to You
At Garcia Family Medicine, your health and safety are our top priorities. We’ll continue monitoring this situation and sharing updates as they become available. If you have concerns about this recall or any medical topic, feel free to reach out to our team—we’re here to help.
Stay safe and informed,
The Garcia Family Medicine Team
