The Red Head 2 Reusable Fat Harvesting Canister — Class II medical device recall Z-1957-2016
Terminated recall by Miami Fat Supply, Inc, reported 2016-06-22, distributed in AL, AZ, CA, CO, FL, GA, IL, MD…. During an FDA inspection it was found that the products are marketed without a cleared 510k, nor is approved f
| Recall number | Z-1957-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Miami Fat Supply, Inc, Groveland, FL, United States |
| Recall initiated | 2016-04-21 |
| Classified | 2016-06-13 |
| Reported by FDA | 2016-06-22 |
| Terminated | 2016-12-14 |
| Distributed | AL, AZ, CA, CO, FL, GA, IL, MD, MI, MO, NM, NY, OH, TX, UT, VA |
| Countries outside the US | DO |
| Quantity | 443 units |
| Reason classes | unapproved product |
| Lot numbers | 1165, 1271 |
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 for recall
During an FDA inspection it was found that the products are marketed without a cleared 510k, nor is approved for multiple use.
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-1957-2016. 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.