Class II — Miami Fat Supply, Inc
| Recalling firm | Miami Fat Supply Inc |
|---|---|
| Registered facility | MIAMI FAT SUPPLY INC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | During an FDA inspection it was found that the products are marketed without a cleared 510k, nor is approved for multiple use. |
| Product | The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended for use in aspirating subcutaneous fatty tissue in patients desiring aesthetic body contouring and autologous fat collection. |
| Quantity | 443 units |
| Distribution | Worldwide Distribution -- US, including the states of AL, AZ, CA, CO, FL, GA, IL, MD, MI, MO, NM, NY, OH, TX, UT, and VA; and, the country of Dominican Republic. |
| Initiated | 2016-04-21 |
| Classified | 2016-06-13 |
| Terminated | 2016-12-14 |
| Recall number | Z-1957-2016 |
| 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 — Miami Fat Supply, Inc (Z-1957-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74156/
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