CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000 — FDA record Z-1349-2022

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. Source coverage and dates.

What the record says

Product
CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000
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
2,686 units
Agency-reported status
Ongoing
Source record identifier
Z-1349-2022

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityCoolCurve+ REF: BRZ-AP1-064-000 BRZ-AP1-064-000_R UDI-DI: 00816417020193 Serial Numbers: V0642017122012 V0642016285020 V0642016285018 V0642016173010 V0642016173009 V0642016173007 V0642016173005 V0642016173003 V0642016173002 V0642016173001 V0642016167020 V0642016167019 V0642016167018 V0642016167017 V0642016167015 V0642016167013 V0642016167011 V0642016167009 V0642016167007 V0642016167006 V0642016167002 V0642016167001 V0642016160019 V0642016160018 V0642016160017 V0642016160014 V0642016160013 V0642016160012 V0642016160009 V0642016160008 V0642016160005 V0642016160003 V0642016160002 V0642016127020 V0642016127019 V0642016127018 V0642016127017 V0642016127016 V0642016127014 V0642016127013 V0642016127011 V0642016127008 V0642016127006 V0642016127005 V0642016127004 V0642016127001 V0642016125019 V0642016125018 V0642016125017 V0642016125016 V0642016125015 V0642016125014 V0642016125013 V0642016125011 V0642016125010 V0642016125009 V0642016125008 V0642016125007 V0642016125006 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The agency lot list is longer than this excerpt. Read the complete list at the official source.

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.

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.

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