Burlington Medical Protective Sleeves Recall
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Burlington Medical, LLC is recalling 1,129 units of Protective Sleeves due to potential attenuation degradation that could decrease their lifespan.
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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What Happened
Burlington Medical, LLC has initiated a voluntary recall of their Protective Sleeves due to the potential for attenuation degradation over time, which may decrease the product's lifespan.
Which Products Are Affected
The recall affects 1,129 units of Burlington Medical Protective Sleeves manufactured with Xenolite 800 attenuation material from January 16, 2025, to January 21, 2026. The affected models include: 1. Model Number: R8SL with UDI-DI 00840331271904 (Product Code: SL8-R8SL). 2. Model Number: R8SL3 with UDI-DIs 00840331271911 (SL38-R8SL3-LG), 00840331271928 (SL38-R8SL3-MD), 00840331271935 (SL38-R8SL3-SM), 00840186699816 (SL38-R8SL3-XL), and 00840331271942 (SL38-R8SL3-XS). 3. Model Number: S8SL with UDI-DI 00840331271959 (SL8-S8SL). 4. Model Number: S8SL3 with UDI-DIs 00840331271966 (SL38-S8SL3-LG), 00840331271973 (SL38-S8SL3-MD), 00840331271980 (SL38-S8SL3-SM), 00840186699823 (SL38-S8SL3-XL), and 00840331271997 (SL38-S8SL3-XS). 5. Model Number: U8SL with UDI-DI 00840331272000 (SL8-U8SL). 6. Model Number: U8SL3 with UDI-DIs 00840331272017 (SL38-U8SL3-LG), 00840331272024 (SL38-U8SL3-MD), 00840331272031 (SL38-U8SL3-SM), 00840186699830 (SL38-U8SL3-XL), and 00840331272048 (SL38-U8SL3-XS). All serial numbers from the specified date range are affected. The products were distributed nationwide in the US and internationally to Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay, and Vietnam.
What You Should Do
Consumers who have the affected Protective Sleeves should contact Burlington Medical, LLC at their address: 3 Elmhurst St, Suite 112, Newport News, VA 23603-1137, as they were notified via letter, for instructions on returns or refunds.
Why This Matters
This recall addresses a potential safety issue with protective devices that could impact their effectiveness over time, potentially affecting users who rely on them for protection in relevant settings.
Source
According to the FDA recall notice with number Z-1759-2026.
Original source: FDA Official Notice ↗
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