Miami Fat Supply, Inc: Medical Device Recall in 2016 - (Recall #: Z-1957-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: April 21, 2016

Date Posted: June 22, 2016

Recall Number: Z-1957-2016

Event ID: 74156

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.

Status: Terminated

Product Quantity: 443 units

Code Information:

Lots 1165 and 1271.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated