FDA Recalls medium

Recall of Burlington Medical Leg Wraps Due to Attenuation Degradation

Source: FDA · United States

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Burlington Medical, LLC is recalling 103 units of their Leg Wraps because of potential attenuation degradation over time, which could decrease the product's lifespan.

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

This notice was issued by FDA on April 14, 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 voluntarily recalling their Leg Wraps due to a potential for attenuation degradation over time, which decreases the lifespan of the product.

Which Products Are Affected

The recall affects 103 units of Burlington Medical Leg Wraps. All serial numbers manufactured with Xenolite 800 attenuation material from January 16, 2025, to January 21, 2026, are included. The specific models are:

  • Model Number: R8LGW1; UDI-DI: 00840331272079 (Product Code: LGW8SET-R8LGW1)
  • Model Number: R8LGW2; UDI-DI: 00840331272086 (Product Code: LGW8SET-R8LGW2)
  • Model Number: R8LGW3; UDI-DI: 00840331272055 (Product Code: LGW8SET-R8LGW3)
  • Model Number: S8LGW1; UDI-DI: 00840331272116 (Product Code: LGW8SET-S8LGW1)
  • Model Number: S8LGW2; UDI-DI: 00840331272123 (Product Code: LGW8SET-S8LGW2)
  • Model Number: S8LGW3; UDI-DI: 00840331272093 (Product Code: LGW8SET-S8LGW3)
  • Model Number: S8LGW4; UDI-DI: 00840331272109 (Product Code: LGW8SET-S8LGW4)
  • Model Number: U8LGW1; UDI-DI: 00840331272154 (Product Code: LGW8SET-U8LGW1)
  • Model Number: U8LGW2; UDI-DI: 00840331272161 (Product Code: LGW8SET-U8LGW2)
  • Model Number: U8LGW4; UDI-DI: 00840331272147 (Product Code: LGW8SET-U8LGW4) The distribution was nationwide in the US and international to countries including Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay, and Vietnam.

What You Should Do

The firm has initiated this recall voluntarily and notified via letter. Consumers should contact Burlington Medical, LLC at 3 Elmhurst St, Suite 112, Newport News, VA 23603-1137 for instructions on the recall, including returns or refunds.

Why This Matters

This recall ensures the safety and effectiveness of medical devices, as degradation could impact their performance over time.

Source

FDA recall announcement, recall number Z-1761-2026.

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 recalling 103 units of their Leg Wraps because of potential attenuation degradation over time, which could decrease the product's lifespan.
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.

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