FDA Device recall Z-1957-2016
The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile
- FDA Device
- Class II
- terminated
- Published 2016-06-22
On 2016-06-22 the FDA classified a Class II recall of The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile by Miami Fat Supply, citing during an FDA inspection it was found that the products are marketed without a cleared 510k, nor is approved for multiple use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1957-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-21 |
| Published | 2016-06-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Miami Fat Supply |
| Distribution | AL, AZ, CA, CO, FL, GA, IL, MD, MI, MO, NM, NY, OH, TX, UT, VA |
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.
Reason
During an FDA inspection it was found that the products are marketed without a cleared 510k, nor is approved for multiple use.
Identifiers
| code_info | Lots 1165 and 1271. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1957-2016%22
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