LifeVac Update: What Parents Need to Know About the Recent FDA Warning

You may have seen recent headlines about the LifeVac anti-choking device. The FDA has issued a formal warning letter to the company, stating that LifeVac is not FDA-approved and that its safety and effectiveness have not been proven through clinical studies.

Because Newborn Prep 101 has previously discussed this product in class, we want every family to have the most accurate and up-to-date information.

🩺 What We Know

  • FDA Warning: The FDA has directed LifeVac to stop marketing its device as a medical product until proper authorization is obtained.

  • Potential Risks: The FDA has received reports of incidents where the device did not dislodge an object or caused minor injuries (like bruising or throat irritation).

  • No Major Endorsements: The American Red Cross and American Heart Association currently do not recommend any anti-choking suction devices.

  • Proven Methods Still Come First: Back blows, abdominal thrusts (Heimlich maneuver), and calling 911 remain the gold-standard response for choking emergencies.

❓ What We Don’t Yet Know

  • Whether suction devices are as effective or safe as established methods.

  • How often they might fail or cause harm in real-world use.

  • Whether they might delay care if rescuers hesitate or spend time assembling the device.

  • Long-term safety and legal considerations if the device fails to perform.

💡 Our Recommendation

If you already have a LifeVac, it’s okay to keep it as a last-resort option, but it should never replace CPR or standard choking response training.

The most important steps remain:

  1. Stay calm

  2. Give back blows and abdominal thrusts as trained

  3. Call 911 immediately

  4. If those steps fail, a suction device may be used as a final option

🧡 Stay Informed, Stay Prepared

We’ll continue to follow updates from the FDA and professional organizations and share any new guidance as it becomes available.

For choking prevention tips and CPR education opportunities, visit Newborn Prep 101 Classes ➜ or contact us at info@newbornprep101.com.