{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "161427", "product_res_number": "Z-0823-2018", "event_date_initiated": "2017-08-08", "event_date_created": "2018-03-01", "recall_status": "Terminated", "event_date_terminated": "2018-09-07", "res_event_number": "79136", "product_code": "MUU", "k_numbers": [ "K120902" ], "product_description": "REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.", "code_info": "Lot Number/Expiration Dates:  1) 10565 & 10641 - 5/31/2017 2) 10651, 10658, 10626 & 10628 - \t6/30/2017 3) 10642, 10630, 10643, 10629, 10631 - 7/31/2017 4) 10669, 10633, 10634 & 10635 -\t8/31/2017 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", "firm_fei_number": "1000306051", "recalling_firm": "LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC", "address_1": "1 Millennium Way", "city": "Branchburg", "state": "NJ", "postal_code": "08876-3876", "additional_info_contact": "908-947-1100", "reason_for_recall": "Presence of bacterial endotoxins levels above the acceptable limit", "root_cause_description": "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: \nActions to be taken\n1. 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\nletter.\n2. 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.\n3. Mail the postage paid BRF immediately. To assure that we can account for all recalled product, it is imperative that you return the BRF.\n4. 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\nSlip to:\nGENCO Pharmaceutical Services (GPS), a subsidiary of FedEx Supply Chain\n6101 North 64th Street, Milwaukee, WI 53218\n\nFor 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.\n\nFor 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\n\nFor Credit or", "product_quantity": "25,798 units", "distribution_pattern": "US Nationwide, Canada, Australia, Chile, Brazil, Israel, Japan New Zealand & Singapore", "openfda": { "k_number": [ "K120328", "K193363", "K092482", "K092923", "K210528", "K142682", "K191564", "K203800", "K072587", "K141713", "K161372", "K171135", "K132815", "K141591", "K121005", "K162932", "K202443", "K190386", "K190278", "K172714", "K102117", "K101713", "K150156", "K163647", "K083455", "K081848", "K161636", "K120902", "K182732", "K150779", "K170449", "K100114", "K193539", "K121703", "K113255", "K130152", "K172717", "K171242", "K092284", "K142073" ], "registration_number": [ "3008717566", "2030598", "3011710821", "1054811", "3006798004", "3010531069", "1420032", "1058584", "1066491", "1313525", "1222993", "3008624479", "1211566", "3008719017", "1937141", "1423662", "3006053983", "3016467822", "1649660", "2020601", "2032809", "3017791237", "3021284635", "3011707889", "1649518", "3010173425", "3007137651", "3010742783", "3009420598", "2024024", "3004167969", "2219920", "3012441529", "2030624", "1220477", "3016080683", "3011423170", "2953359", "3009882464", "1720734", "1222928" ], "fei_number": [ "3008717566", "3011710821", "1000219637", "3004106598", "3010531069", "3001236277", "1420032", "3006798004", "1000120578", "3008624479", "1000114185", "1211566", "3008719017", "3006053983", "3004169154", "3003429569", "3016467822", "2020601", "3017791237", "3021284635", "3011707889", "3007137651", "3000215205", "3001451796", "3010742783", "1000117446", "3009420598", "2024024", "3004167969", "1000120613", "3000215273", "2219920", "3012441529", "1317628", "3000206435", "3016080683", "1000518731", "1220477", "3002807036", "3009882464", "1720734" ], "device_name": "System, Suction, Lipoplasty", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.5040", "device_class": "2" } } ] }