The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-3066-2017·Announced 2017-08-30

Shippert Medical Technologies Recalls Tissu-Trans SFILL 360 Due to Seal Integrity

Shippert Medical Technologies is recalling Tissu-Trans SFILL 360 devices because the seal integrity of the sterile packages cannot be assured.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where the integrity of the sterile seal is compromised, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Shippert Medical Technologies is recalling 5,188 units of the Tissu-Trans SFILL 360 and 3-TT-SFILL 360 medical devices. These products are intended for fat transfer and liposuction procedures. The recall is being conducted because the seal integrity of the sterile packages cannot be assured.

The affected units are identified by lot numbers 12079, 61117, 61143, and 61405. The products were distributed nationwide in the United States and internationally to countries including Italy, Austria, Turkey, and the United Kingdom.

Consumers and healthcare providers should stop using the affected devices and contact Shippert Medical Technologies for further instructions on how to proceed.

The recalled product

Product
Tissu-Trans SFILL 360, 3-TT-SFILL 360. Product Usage: Intended for fat transfer and liposuction.
Manufacturer
Shippert Medical Technologies
Category
Medical Device — Surgical Instrument
Hazard
Affected units
5,188

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 (4)

  • Lot Numbers 12079
  • 61117
  • 61143
  • 61405.

Distribution

Distributed nationwide across the United States.

The notice also names 30 states specifically:

Part of a larger recall action

This product is one of 7 recalled by Shippert Medical Technologies under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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