--- title: "CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000 — FDA record Z-1346-2022 | Is It on Recall" description: "Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP)" url: https://isitonrecall.com/recall/fda-device-z-1346-2022-coolmax-zeltiq-vacuum-applicator-ref-brz-ap1-080-000/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000 — FDA record Z-1346-2022 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Jun 9, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000 - **Reason**: Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP) during the 2019 to 2021 timeframe. - **Classification**: Class II - **Recalling firm**: Zeltiq Aesthetics, Inc - **Quantity**: 2,945 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1346-2022 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1346-2022%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | CoolMax BRZ-AP1-080-000 BRZ-AP1-080-000-R UDI-DI: 00816417020230 Serial Numbers: V082010246001 V0802018039018 V0802017153007 V0802017138015 V0802017138013 V0802016258020 V0802016258017 V0802016258014 V0802016258012 V0802016258008 V0802016258006 V0802016258003 V0802016235037 V0802016235032 V0802016235030 V0802016235024 V0802016235022 V0802016235017 V0802016235016 V0802016235010 V0802016235002 V0802016229019 V0802016229018 V0802016229012 V0802016229010 V0802016229009 V0802016229008 V0802016229003 V0802016218011 V0802016218009 V0802016217010 V0802016217008 V0802016217005 V0802016217004 V0802016217002 V0802016214036 V0802016214033 V0802016214031 V0802016214029 V0802016214022 V0802016214021 V0802016214013 V0802016214012 V0802016214010 V0802016214009 V0802016214008 V0802016214007 V0802016214006 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V0802015212018 V0802015212017 V0802015212016 V0802015212013 V0802015212011 V0802015212010 V0802015212003 V0802015212002 V0802015212001 V0802015210020 V0802015210017 V0802015210016 V0802015210014 V0802015210013 V0802015210012 V0802015210011 V0802015210010 V0802015210009 V0802015210008 V0802015210007 V080201... | The agency lot list is longer than this excerpt. [Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1346-2022%22). Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution U.S. AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: United Arab Emirates, Argentina, Austria, Australia, Belgium, Bahrain, Bolivia, Canada, Switzerland, China, Cyprus, Czechia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, The Republic of Korea, Kuwait, Lebanon, Luxembourg, Latvia, Mexico, The Netherlands, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Sweden, Singapore, Thailand, Turkey, Taiwan, Uruguay, Venezuela, and South Africa. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [District of Columbia](https://isitonrecall.com/state/district-of-columbia/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Jul 20, 2022 - **Recall initiation date**: Jun 9, 2022 - **Center classification date**: Jul 11, 2022 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1346-2022%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Zeltiq Aesthetics, Inc records](https://isitonrecall.com/brand/zeltiq-aesthetics-inc/)