VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite… — Class II medical device recall Z-1661-2013
Terminated recall by DJO, LLC, reported 2013-07-10, distributed nationwide. DJO, LLC has recently identified a product safety issue with the battery assembly for the VenaFlow 30B-B and 3
| Recall number | Z-1661-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DJO, LLC, Vista, CA, United States |
| Recall initiated | 2013-05-28 |
| Classified | 2013-07-03 |
| Reported by FDA | 2013-07-10 |
| Terminated | 2014-02-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CN, ES, FR, GB, GT, HK, IN, IT, KR, LB, MA, MY, NL, PK, PY, RO, SE, SG, TH, TR |
| Quantity | 2,491 |
| Reason classes | packaging |
| Serial numbers | E00026, E00029, E00030, E00031, E00036, E00039, E00045, E00050, E00051, E00052, E00053, E00056, E00057, E00058, E00060, E00143, E00147, E00151, E00156, E00163, E00169, E00175, E00178, E00184, E00191 and 475 more |
| Model numbers | 30B-B, 30BI-B |
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.
Reason for recall
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1661-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.