Reported Mar 7, 2018 · Terminated

REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue…

LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC · 1 Millennium Way · Branchburg, NJ · 08876-3876

Is this the product you have?

  • REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.
Lot codes and dates

21 of 21 products

Products covered by this recall
#Product as published
110565 & 10641 - 5/31/2017
210651, 10658, 10626 & 10628 - 6/30/2017
310642, 10630, 10643, 10629, 10631 - 7/31/2017
410669, 10633, 10634 & 10635 - 8/31/2017
510636 & 10637 - 9/30/2017
610736, 10693, 10695 & 10694 -10/31/2017
710698, 10699, 10696 & 10697 -11/30/2017
810700, 10701 & 10702 - 12/31/2017
910704, 10705, 10703 & 10799 -1/31/2018
1010706, 10708 & 10785 - 2/28/2018
1110791, 10792, 10786, 10787 & 10707 - 3/31/2018
1210838, 10793, 10795, 10794 & 10788 - 4/30/2018
1310789, 10840 & 10796 - 5/31/2018
1410841, 10709, 10825 & 10782 - 6/30/2018
1510826, 10827 & 10783 - 7/31/2018
1611222, 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
1711236, 11237, 11247, 11232, 11230, 11233, 11219, 11231, 11262 & 11085 - 9/30/2018
1811553, 11554, 11252, 11556, 11087, 11555, 11090, 11249, 11253, 3038912, 11254, 3038910 & 3097870 - 10/31/2018
1911250, 11251, 11325, 11324, 11560 & 3103907 - 11/30/2018
2011326, 11328, 11327, 11331, 11329, 11330, 11820, 11819, 11578, 11821, 11822 & 11579 -1/31/2019
Amount recalled
25,798 units

Where it was sold

  • Nationwide

Why it was recalled

Presence of bacterial endotoxins levels above the acceptable limit

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 7, 2018 · Data as of Sep 19, 6:07 PM UTC

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