MicroAire Lipofilter 3000 Canisters Recalled for Sterilization Defects
MicroAire Surgical Instruments is recalling 15 Lipofilter 3000 fat collection canisters because they were not manufactured under Good Manufacturing Procedures, potentially preventing proper sterilization.
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 is classified as FDA Class II and involves a risk-of-harm product (inability to sterilize) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
MicroAire Surgical Instruments, LLC is recalling 15 units of the Lipofilter 3000, model ASP-CAN-2, fat collection canisters. These devices are intended for use during liposuction procedures. The recall was initiated because the medical devices were not manufactured under Good Manufacturing Procedures (GMP). As a result, users may be unable to sterilize the devices according to standard procedures.
The affected devices are identified by Lot Number 0312200152. The products were distributed nationwide in the United States, including the states of California, Ohio, and New York. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare providers and facilities that have received these devices should stop using them immediately. Users should contact MicroAire Surgical Instruments, LLC for instructions on how to return the devices for replacement or refund. Patients who have had liposuction procedures using these specific canisters should consult their healthcare provider if they have concerns regarding the sterilization process.
The recalled product
- Product
- Lipofilter 3000, model ASP-CAN-2, labeled in part ***MicroAire, 1641 Edlich Drive, Charlottesville, VA 22911, USA*** Product Usage: A fat collection canister intended for use during liposuction procedures.
- Manufacturer
- MicroAire Surgical Instruments, LLC
- Affected units
- 15
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)
- Lot Number: 0312200152
Distribution
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