Z-1957-2016Class II

The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended for use in aspirating...

Name: Z-1957-2016 The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended for use in aspirating...
Creator: Miami Fat Supply, Inc
Published: 2016-04-21
License: https://open.fda.gov/license/

Miami Fat Supply, Inc / initiated 2016-04-21 / Terminated

FDA source

Miami Fat Supply, Inc began a recall of The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended for use in aspirating subcutaneous fatty tissue in patients desiring... on 2016-04-21. FDA classified it as Class II and gives the reason as "During an FDA inspection it was found that the products are marketed without a cleared 510k, nor is approved for multiple use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1957-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-21
Posted: 2016-06-14
Terminated: 2016-12-14
Recalling firm: Miami Fat Supply, Inc
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.
Product code: MUU System, Suction, Lipoplasty
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.
FDA root cause: No Marketing Application
Action: Customers were sent an Urgent: Medical Device Recall/Correction letter, dated 04/19/2016, on 04/21/2016 that served as a notification of the Red Head 2 voluntary recall. Customers were informed that there were previous complaints of compromised product integrity and performance following sterilization. Lids are subject to fracture and fail after steam sterilization. Customers were advised to destroy used product and to ship unused product back to the manufacturer. Customers were to return an acknowledgement form to confirm their notification of the voluntary recall.
Quantity in commerce: 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.
Product codes and lots: Lots 1165 and 1271.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1957-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1957-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-13

Product code MUU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)