LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC: REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.

Recall number

Z-0823-2018

Recalling firm

LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC

Product

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

Status

Terminated

Initiated

2017-08-08

Posted

not on file

Terminated

2018-09-07

Reason

Presence of bacterial endotoxins levels above the acceptable limit

Root cause

Material/Component Contamination

Action

The firm's initial notice to customers (dated May 25, 2017) advising customers that Allergan has placed a hold on shipping the device until verification is complete. Within this notice, customers were advised to continue use of the product. On June 14, 2017, a second notice was issued to customers informing customers that product shipments will resume by August 1, 2017 and that manufacturing process improvements will be implemented. On August 8, 2017, Allergen distributed URGENT MEDICAL DEVICE RECALL notices and Business Reply Forms (dated August 2, 2017) to US customers advising them to take the following Actions: Actions to be taken 1. Immediately examine your inventory and quarantine all product subject to this recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall, and that all product should be quarantined. Your notification to your customers may be enhanced by including a copy of this recall notification letter. 2. Carry out a physical count of the affected product in your possession and record the count on the enclosed postage paid Business Reply Form (BRF) and Packing slip. 3. Mail the postage paid BRF immediately. To assure that we can account for all recalled product, it is imperative that you return the BRF. 4. When returning the recalled product, attach the prepaid FedEx Authorized Return shipping label to the outside of the return carton. Return the recalled product and completed Packing Slip to: GENCO Pharmaceutical Services (GPS), a subsidiary of FedEx Supply Chain 6101 North 64th Street, Milwaukee, WI 53218 For Product Returns: Contact Genco Pharmaceutical Services, a subsidiary of FedEx Supply Chain at: 1-877-319-8961 during the hours of 7 AM - 5 PM CST. For Adverse Events/Product Complaints: Contact LifeCell at 1-800-367-5737, during the hours of 9 AM - 5 PM EST or via Email: complaintfeedbackregistration@lifecell.com For Credit or

Quantity

25,798 units

Distribution

US Nationwide, Canada, Australia, Chile, Brazil, Israel, Japan New Zealand & Singapore

Lot, serial or model codes

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

510(k) numbers

["K120902"]

PMA numbers

not on file

Product code

MUU

Firm FEI

1000306051

Firm city

Branchburg

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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