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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Surgical Equipment

Getinge Sevoflurane Vaporizers Recalled for Toxic Chemical Risk

Agency Publication Date: February 7, 2025
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Summary

Getinge USA Sales Inc. has recalled 6 units of its Sevoflurane Vaporizer (Quik-Fil, Model 6682285) because the anesthesia drug sevoflurane may degrade into hydrogen fluoride when used with the device. This degradation can lead to toxic exposure for both patients and healthcare providers through inhalation or skin contact. The vaporizer is a component used in Flow-i C20, C30, C40, and Flow-c/e anesthesia systems. No injuries have been reported, but potential harms include severe lung irritation, chemical burns, and dangerous mineral imbalances in the blood.

Risk

The anesthetic gas can break down into hydrogen fluoride, a toxic chemical that causes severe respiratory irritation, lung fluid buildup (edema), and chemical skin ulcers if touched or inhaled.

What You Should Do

  1. The recalled products are Sevoflurane Vaporizer (Quik-Fil) units, model number 6682285, which are used as components in Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, and Flow-e anesthesia machines.
  2. Check the serial numbers on your vaporizers to see if they match the affected units: 3761, 7635, 7633, 7630, 7632, or 7631.
  3. Stop using the recalled device. Contact Getinge USA Sales Inc. or your distributor to arrange for a return, replacement, or correction of the equipment.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Vaporizer Sevoflurane, Quik-Fil
Model / REF:
6682285
Serial Numbers:
3761
7635
7633
7630
7632
7631
UDI:
07325710001141

Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96083
Status: Active
Manufacturer: Getinge Usa Sales Inc
Sold By: Authorized Medical Distributors
Manufactured In: United States
Units Affected: 6 units
Distributed To: Kentucky, Connecticut

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.