Class II — DJO, LLC
| Recalling firm | DJO, LLC |
|---|---|
| Registered facility | View this company's 11 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | DJO, LLC has recently identified a product safety issue with the battery assembly for the VenaFlow 30B-B and 30 BI-B products. There is a potential for battery leakage which could result in thermal meltdown (fire). |
| Product | VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis. |
| Quantity | 2491 |
| Distribution | Worldwide Distribution - USA Nationwide and countries of: Australia, Belgium, China, Guatemala CentroAmeria, France, Hong Kong, India,Italy, Korea, Lebanon, Malaysia, Morocco, Pakistan, Paraguay, The Netherlands, Romania, Singapore, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom and Venezula. |
| Initiated | 2013-05-28 |
| Classified | 2013-07-03 |
| Terminated | 2014-02-13 |
| Recall number | Z-1661-2013 |
| 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 — DJO, LLC (Z-1661-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65493/
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