Class II — Burlington Medical, LLC
| Recalling firm | Burlington Medical LLC |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Potential for attenuation degradation over time, decreasing the lifespan. |
| Product | Burlington Medical, Caps. |
| Quantity | 961 units |
| Distribution | Worldwide distribution. Nationwide distribution in the US and international distribution to Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay, and Vietnam. |
| Initiated | 2026-02-11 |
| Classified | 2026-04-02 |
| Recall number | Z-1760-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Burlington Medical, LLC (Z-1760-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98415/
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