LifeCell Revolve Advanced Adipose System Recalled for Bacterial Endotoxins
LifeCell is recalling 25,798 units of the Revolve Advanced Adipose System due to bacterial endotoxin levels above acceptable limits.
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 the hazard involves a high-risk pathogen (bacterial endotoxins) without reported illness, which aligns with the 'High' severity criteria.
Plain-English summary
LifeCell Corporation, a wholly owned subsidiary of Allergan PLC, is recalling 25,798 units of the Revolve Advanced Adipose System. This medical device is used for the aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.
The recall was initiated because the product contains bacterial endotoxin levels that exceed the acceptable limit. The affected units were distributed in the United States, Canada, Australia, Chile, Brazil, Israel, Japan, New Zealand, and Singapore.
The recall covers specific lot numbers with expiration dates ranging from May 31, 2017, to February 28, 2019. Users of this device should contact LifeCell Corporation for further instructions regarding the return or replacement of the affected units.
The recalled product
- Product
- REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.
- Hazard
- Affected units
- 25,798
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 (20)
- Lot Number/Expiration Dates: 1) 10565 & 10641 - 5/31/2017 2) 10651
- 10658
- 10626 & 10628 - 6/30/2017 3) 10642
- 10630
- 10643
- 10629
- 10631 - 7/31/2017 4) 10669
- 10633
- 10634 & 10635 - 8/31/2017 5) 10636 & 10637 - 9/30/2017 6) 10736
- 10693
- 10695 & 10694 -10/31/2017 7) 10698
- 10699
- 10696 & 10697 -11/30/2017 8) 10700
- 10701 & 10702 - 12/31/2017 9) 10704
- 10705
- 10703 & 10799 -1/31/2018 10) 10706
- 10708 & 10785 - 2/28/2018 11) 10791
- 10792
- 10786
- 10787 & 10707 - 3/31/2018 12) 10838
Distribution
Distributed nationwide across the United States.
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