ReTurn belt — Class II medical device recall Z-1613-2015
Terminated recall by Handicare USA, Inc., reported 2015-05-20, distributed in CA, FL, MD, NC, NJ. Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied.
| Recall number | Z-1613-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Handicare USA, Inc., Allentown, PA, United States |
| Recall initiated | 2015-03-26 |
| Classified | 2015-05-14 |
| Reported by FDA | 2015-05-20 |
| Terminated | 2015-08-17 |
| Distributed | CA, FL, MD, NC, NJ |
| Quantity | 64 |
| Lot numbers | 1402S |
| Model numbers | 6133-6136 |
Product
ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid.
Reason for recall
Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied.
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-1613-2015. 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.