Burlington Medical Caps Recall
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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,353 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 16, 2026.
Frequently Asked Questions
Common questions about this FDA recall.