Revolve Advanced Adipose System recall: Endotoxin
REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.
Why was Revolve Advanced Adipose System recalled?
Presence of bacterial endotoxins levels above the acceptable limit
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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, 10793, 10795, 10794 & 10788 - 4/30/2018 13) 10789, 10840 & 10796 - 5/31/2018 14) 10841, 10709, 10825 & 10782 - 6/30/2018 15) 10826, 10827 & 10783 - 7/31/2018 16) 11222, 11224, 11234, 11235, 11223, 11225, 11089, 11246, 10790, 10830, 11208, 11210, 11214, 11215, 11209, 11217, 11211, 11216, 11212, 11213, 11226, 11229, 11227 &11228 - 8/31/2018 17) 11236, 11237, 11247, 11232, 11230, 11233, 11219, 11231, 11262 & 11085 - 9/30/2018 18) 11553, 11554, 11252, 11556, 11087, 11555, 11090, 11249, 11253, 3038912, 11254, 3038910 & 3097870 - 10/31/2018 19) 11250, 11251, 11325, 11324, 11560 & 3103907 - 11/30/2018 20) 11326, 11328, 11327, 11331, 11329, 11330, 11820, 11819, 11578, 11821, 11822 & 11579 -1/31/2019 21) 11256, 11255, 11088, 11257, 11852, 11853 & 11854- 2/28/2019
- Product
- REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.
- Recalling firm
- LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC
- Quantity
- 25,798 units
- Distribution
- US Nationwide, Canada, Australia, Chile, Brazil, Israel, Japan New Zealand & Singapore
- Recall date
- March 7, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)