Class II — Handicare USA, Inc.
| Recalling firm | Handicare USA, Inc. |
|---|---|
| Registered facility | Handicare USA, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied. |
| Product | ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid. |
| Quantity | 64 |
| Distribution | US Distribution to the states of : FL, CA, NJ, NC and MD. |
| Initiated | 2015-03-26 |
| Classified | 2015-05-14 |
| Terminated | 2015-08-17 |
| Recall number | Z-1613-2015 |
| 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 — Handicare USA, Inc. (Z-1613-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70995/
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