Miami Fat Supply Recalls Red Head 2 Fat Harvesting Canisters
Miami Fat Supply is recalling 443 Red Head 2 Reusable Fat Harvesting Canisters because they were marketed without FDA clearance and are not approved for multiple use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is regulatory (lack of clearance/approval for reuse) rather than a confirmed acute safety failure, fitting the Moderate criteria for low-risk or theoretical hazards without reported harm.
Plain-English summary
Miami Fat Supply, Inc. is recalling 443 units of the Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. The device is intended for aspirating subcutaneous fatty tissue in patients seeking aesthetic body contouring and autologous fat collection. The affected lots are 1165 and 1271.
The recall was initiated after an FDA inspection revealed that the products were marketed without a cleared 510(k) submission. Additionally, the devices are not approved for multiple use. The agency has classified this recall as Class II.
The affected units were distributed worldwide, including in the United States (specifically in AL, AZ, CA, CO, FL, GA, IL, MD, MI, MO, NM, NY, OH, TX, UT, and VA) and the Dominican Republic. Consumers and healthcare providers should stop using the affected devices and contact Miami Fat Supply, Inc. for further instructions.
The recalled product
- 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.
- Manufacturer
- Miami Fat Supply, Inc
- Affected units
- 443
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lots 1165 and 1271.
Distribution
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