On November 22, 2025, the FDA released details regarding a significant recall of the i-View Video Laryngoscope, manufactured by Intersurgical Inc. This recall addresses serious risks associated with the device’s functionality and battery performance—issues that could lead to severe patient harm, including death. Clinical teams, quality departments, and regulatory professionals must act promptly to mitigate risks.
What changed?
The i-View Video Laryngoscope recall was initiated on June 17, 2025, when Intersurgical Inc. sent an Urgent Medical Device Recall notice to affected customers. The FDA classified this recall as the most serious type due to potential risks posed by continued use of the device. The primary issues involve devices failing to activate, leaking battery fluid, and screens going blank during use. These malfunctions compromise the device’s ability to provide critical visual guidance during oral tracheal intubation procedures.
Who is affected?
The recall affects devices with the model number 8008000 and specific lot numbers—1240555 and 1240793. Any healthcare facilities, distributors, or individuals holding these devices must immediately cease their use and quarantine all affected stock. Additionally, downstream customers who may have received redistributed stock should be notified as soon as possible to return their units.
Why this recall matters
Intersurgical Inc. stated that malfunctioning devices could result in adverse health consequences, including trauma, oxygen desaturation, hypoxia, damage to the oropharynx, aspiration of gastric contents, and, in extreme cases, death. Timely detection and removal of faulty devices are essential to prevent patient harm.
Although no serious injuries or deaths have been reported as of June 20, 2025, the potential risks underscored by the FDA highlight the necessity of immediate action for health care providers managing airway procedures.
Device use and intended purpose
The i-View Video Laryngoscope is designed for direct and indirect visualization of the larynx to assist practitioners with oral tracheal intubation in adult patients. Proper functionality is critical in emergency and routine settings where airway management ensures patient survival.
Manufacturer contact information
Affected customers in the United States seeking guidance on managing the recalled products can contact Intersurgical Inc. at 1-800-828-9633 or email recalls@intersurgicalinc.com. Prompt communication with the manufacturer will support compliance efforts and ensure proper reporting of affected units.
Actions required
If your facility possesses affected units:
- Immediately discontinue their use and quarantine all stock.
- Contact customers who may have received redistributed products and request the items be returned.
- Collaborate with the manufacturer to facilitate proper disposal or replacement.
- Report adverse reactions or quality concerns to the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting Program.
Conclusion
The recall of the i-View Video Laryngoscope serves as a critical reminder for clinical and regulatory teams to remain vigilant when evaluating device performance. Addressing this issue promptly will safeguard patient outcomes and enhance compliance within affected facilities. Stay informed through FDA resources to ensure updates regarding additional actions or guidance.
Disclaimer
This information is intended for professionals in clinical, quality, and regulatory roles. It does not constitute legal or medical advice. Healthcare providers should refer to the FDA or manufacturer for specific recall instructions.