Shippert Medical Technologies Recalls Tissu-Trans MEGA 1500 Due to Seal Integrity
Shippert Medical Technologies is recalling Tissu-Trans MEGA 1500 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 medical device where the sterile seal integrity cannot be assured, creating a risk of infection or harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Shippert Medical Technologies is recalling 5,188 units of Tissu-Trans MEGA 1500 and 3-TT-MEGA 1500 devices. These products are 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 lot numbers 12082, 12111, 61116, 61236, 61288, 61364, and 61464. The devices were distributed worldwide, including nationwide in the United States and in numerous international countries such as Italy, Austria, Turkey, and Germany.
Healthcare providers and consumers should stop using these devices immediately. Users should contact Shippert Medical Technologies for instructions on how to return the affected units for replacement or refund.
The recalled product
- Product
- Tissu-Trans MEGA 1500, 3-TT-MEGA 1500. Product Usage: Intended for fat transfer and liposuction.
- Manufacturer
- Shippert Medical Technologies
- 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 (7)
- Lot Numbers 12082
- 12111
- 61116
- 61236
- 61288
- 61364
- 61464.
Distribution
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 →Related recalls
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