The Food and Drug Administration (FDA) has issued an important update encouraging the public to use established choking rescue methods approved by the American Red Cross and the American Heart Association. This announcement highlights concerns about the safety, efficacy, and unauthorized marketing of several anti-choking devices currently available in the U.S. market. Clinical, quality, and regulatory professionals should be aware of the regulatory implications and updated enforcement actions targeting these devices.
What changed?
On November 13, 2025, the FDA updated its safety communication, emphasizing that unauthorized over-the-counter (OTC) anti-choking devices pose potential risks during choking emergencies. In contrast to FDA-authorized medical devices, these products lack validation for effectiveness and safety. The FDA warns that reliance on these devices may delay critical, life-saving rescue actions such as back blows and abdominal thrusts.
The FDA further clarified that established choking rescue protocols remain the recommended approach, given their proven high success rates during complete airway block emergencies.
Risks associated with anti-choking devices
Reports submitted to the FDA indicate concerning problems with unauthorized anti-choking devices. These include but are not limited to:
- Failure to resolve choking incidents due to insufficient suction capacity
- Physical injury such as facial bruising, lip damage, and throat scratches
- Potential delays in lifesaving actions caused by preparation steps like unpackaging and assembly
Manufacturers of such devices often claim their products create suction seals around the mouth and remove obstructions from airways. However, none of these devices has received FDA marketing authorization for choking rescue purposes.
FDA actions on unauthorized devices
In response to unauthorized marketing practices, the FDA has taken enforcement actions, including:
- Import Alerts: On October 8, 2025, the FDA issued an import alert targeting OTC suction-based anti-choking devices that lack marketing authorization.
- Warning Letters: LifeVac, LLC received a formal warning on September 18, 2025, advising that its Rescue Suction Device is unauthorized for marketing. DeChoker LLC received a similar warning on May 10, 2021.
- Compliance Notices: The FDA continues to educate manufacturers that device registration and listing do not equate to FDA clearance, approval, or authorization.
The agency remains committed to ensuring manufacturers align their products with FDA requirements and standards.
How to verify device authorization
Professionals and consumers can confirm whether a medical device is FDA-authorized by searching the FDA’s Medical Device Databases for De Novo classifications, Premarket Approvals (PMA), or Premarket Notifications (510(k)).
Recommendations for professionals
The FDA urges clinical teams and caregivers to educate patients about choking rescue protocols. These well-established methods, approved by recognized organizations, are immediate and effective for addressing complete airway blocks.
Healthcare providers should also warn patients about the potential risks tied to unauthorized anti-choking devices. Key educational points include:
- Always apply established rescue protocols before attempting other interventions.
- Intervene only during complete airway blocks, as partial blocks can resolve naturally without external actions.
- Review FDA updates on device classifications and compliance insights.
Implications and actions
The FDA’s stance underscores the importance of adhering to evidence-based rescue protocols while eliminating reliance on unvalidated anti-choking devices. Regulatory, clinical, and caregiver teams should stay informed of evolving enforcement measures and incorporate these updates into patient safety practices.
Through continued vigilance, professionals can ensure critical life-saving actions are timely and effective.
Disclaimer
This blog post is intended for informational purposes only. It should not be considered legal advice or a substitute for professional regulatory guidance regarding medical devices.
Mandatory FDA Information
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/safety-communications/update-fda-encourages-public-follow-established-choking-rescue-protocols-fda-safety-communication