The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-3060-2017·Announced 2017-08-30

Shippert Medical Technologies Recalls Tissu-Trans Filtron 100 Due to Seal Integrity

Shippert Medical Technologies is recalling Tissu-Trans Filtron 100 units 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 medical device where the sterility of the package cannot be assured, creating a risk of harm (infection) even though 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 Filtron 100 (3-TT-FILTRON 100). This medical device is intended for use in fat transfer and liposuction procedures. The recall affects specific lot numbers: 12018, 12045, 12076, and 12109.

The reason for the recall is that the seal integrity of the Tissu-Trans product sterile packages cannot be assured. This issue may compromise the sterility of the device, which is critical for its intended medical use.

The affected units were distributed worldwide, including nationwide in the United States and in numerous international countries such as Italy, Germany, Japan, and the United Kingdom. Healthcare providers and facilities that have received these specific lot numbers should stop using the product and contact the recalling firm for instructions on return or disposal.

The recalled product

Product
Tissu-Trans Filtron 100, 3-TT-FILTRON 100. Product Usage: Intended for fat transfer and liposuction.
Manufacturer
Shippert Medical Technologies
Category
Medical Device — Surgical / Liposuction
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 12018
  • 12045
  • 12076
  • 12109.

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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