Burlington Medical Caps Recall

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.

Burlington Medical, LLC is voluntarily recalling 961 units of their Caps due to potential attenuation degradation over time, affecting devices manufactured between January 16, 2025, and January 21, 2026.

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

This notice was issued by FDA on April 16, 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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What Happened

Burlington Medical, LLC is initiating a recall because of the potential for attenuation degradation over time, which decreases the lifespan of the affected products.

Which Products Are Affected

The recall involves Burlington Medical Caps, with a total of 961 units affected. The products include those manufactured with Xenolite 800 attenuation material from January 16, 2025, to January 21, 2026. Specific models are: 1. Model Number: R8CAP with UDI-DI codes 00840331272185 (CAP8-R8CAP-LG_XL) and 00840331272178 (CAP8-R8CAP-SM_MD); 2. Model Number: S8CAP with UDI-DI codes 00840331272208 (CAP8-S8CAP-LG_XL) and 00840331272192 (CAP8-S8CAP-SM_MD); 3. Model Number: U8CAP with UDI-DI codes 00840331272222 (CAP8-U8CAP-LG_XL) and 00840331272215 (CAP8-U8CAP-SM_MD). Distribution was nationwide in the US and internationally to countries including Canada, Australia, and others.

What You Should Do

Consumers should follow the instructions in the initial firm notification letter from Burlington Medical, LLC, as this was the method of notification for the recall.

Why This Matters

This recall highlights potential safety issues with medical devices that may not perform as intended over time, affecting users who rely on these products for protection.

Source

This information is from FDA records for recall number Z-1760-2026.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Burlington Medical, LLC is voluntarily recalling 961 units of their Caps due to potential attenuation degradation over time, affecting devices manufactured between January 16, 2025, and 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.