FDA Recall of Burlington Medical Vests Due to Attenuation Degradation

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

The FDA has announced a voluntary recall of 15,438 Burlington Medical vests due to potential attenuation degradation over time, affecting devices manufactured from January 16, 2025, to January 21, 2026.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 15, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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FDA Recall of Burlington Medical Vests

What Happened

Burlington Medical, LLC is recalling certain vests due to the potential for attenuation degradation over time, which could decrease the lifespan of the devices. This is a Class II recall initiated voluntarily by the firm.

Which Products Are Affected

The recall involves 15,438 units of various Burlington Medical vests. Affected models include C8PVEST, C8VEST, R8FVEST, R8PVEST, R8QVEST, R8VEST, R8ZVEST, S8FVEST, S8PVEST, S8QVEST, S8VEST, S8ZVEST, U8FVEST, U8PVEST, U8QVEST, U8VEST, and U8ZVEST. These were manufactured with Xenolite 800 attenuation material from January 16, 2025, to January 21, 2026. Specific UDI-DI codes include 00840331297652 for C8PVEST variants, 00840331297645 for C8VEST variants, and many others as listed in the recall details. The products were distributed nationwide in the US and internationally to countries including Canada, Australia, and others.

What You Should Do

Consumers and users should contact Burlington Medical, LLC for instructions regarding the recalled products. The firm initially notified users via letter, and further details can be obtained from the recalling firm at their address: 3 Elmhurst St, Suite 112, Newport News, VA 23603-1137.

Why This Matters

This recall affects over 15,000 units of medical devices, potentially compromising their protective effectiveness in healthcare settings, which could lead to risks for users depending on the devices' intended purpose.

Source

This information is from the FDA recall database, recall number Z-1754-2026. For more details, visit the FDA website at https://www.fda.gov/ and search for the recall ID.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
The FDA has announced a voluntary recall of 15,438 Burlington Medical vests due to potential attenuation degradation over time, affecting devices manufactured from January 16, 2025, to January 21, 2026.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.