Recall Record

Newport News, VA, United States

Burlington Medical, LLC recalls

2 recalls recorded since 2018, most recently on 11 February 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
11 February 2026
Reason
Potential for attenuation degradation over time, decreasing the lifespan.
Distribution
Worldwide distribution. Nationwide distribution in the US and international distribution to Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay, and Vietnam.
Initiated
Voluntary: Firm initiated
Recall numbers
Z-1757-2026, Z-1761-2026, Z-1762-2026, Z-1754-2026, Z-1763-2026, Z-1765-2026, Z-1759-2026, Z-1756-2026, Z-1764-2026, Z-1753-2026, Z-1760-2026, Z-1755-2026 and 1 more

Terminated Class II Medical devices

Recall started
7 June 2019
Terminated
28 April 2023
Reason
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Distribution
US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
Initiated
Voluntary: Firm initiated
Recall numbers
Z-2124-2019, Z-2128-2019, Z-2108-2019, Z-2109-2019, Z-2115-2019, Z-2113-2019, Z-2114-2019, Z-2125-2019, Z-2112-2019, Z-2118-2019, Z-2123-2019, Z-2122-2019 and 12 more

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.