The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-3062-2017·Announced 2017-08-30

Shippert Medical Technologies Recalls Tissu-Trans Filtron 500 Due to Seal Integrity

Shippert Medical Technologies is recalling 5,188 units of Tissu-Trans Filtron 500 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 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, and the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a potential loss of sterility, which fits the criteria for a moderate severity recall involving a theoretical risk without reported harm.

Plain-English summary

Shippert Medical Technologies is recalling 5,188 units of the Tissu-Trans Filtron 500 (3-TT-FILTRON 500). This medical device is intended for use in fat transfer and liposuction procedures. The recall is being conducted because the seal integrity of the sterile packages cannot be assured.

The affected products are identified by the following lot numbers: 11934, 11948, 11984, 12002, 12020, 12046, 61119, 61287, 61363, and 61146. The products 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 consumers should check their inventory for the specific lot numbers listed above. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations to prevent the use of potentially non-sterile equipment.

The recalled product

Product
Tissu-Trans Filtron 500, 3-TT-FILTRON 500. 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 (10)

  • Lot Numbers 11934
  • 11948
  • 11984
  • 12002
  • 12020
  • 12046
  • 61119
  • 61287
  • 61363
  • 61146.

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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