Class II — Impedimed Limited
| Recalling firm | Impedimed Limited |
|---|---|
| Registered facility | Impedimed Limited (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Bilateral L-Dex assessment software does not have the same level of sensitivity to help detect early signs of lymphedema as the unilateral arm L-Dex assessment, which could result in under-recognition of early lymphedema, which could result in delay in early intervention, and more aggressive intervention. |
| Product | SOZO Bilateral Arm L-Dex Software |
| Quantity | 354 |
| Distribution | US Nationwide distribution in the states of IA, CA, IL, AK, NY, FL, KS, WI, MI, NC, GA, SD, KY, TX, MA, LA, AZ, RI, AR, CO, WY, OH, IN, MO, NJ, MD, CT, WA, PA, UT, VA, NM, ME, MN, DC, TN, NE, OR, ND, WV. |
| Initiated | 2023-08-17 |
| Classified | 2023-10-24 |
| Recall number | Z-0155-2024 |
| 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 — Impedimed Limited (Z-0155-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92943/
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