# FDA recall Z-1346-2022

> **Zeltiq Aesthetics, Inc** · Class II · device recall initiated 2022-06-09.

## Product

CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000

## Reason for recall

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.

## 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.

## Key facts

- **Recall number:** Z-1346-2022
- **Recalling firm:** Zeltiq Aesthetics, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-09
- **Report date:** 2022-07-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pleasanton, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1346-2022

## Citation

> AI Analytics. FDA recall Z-1346-2022. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-1346-2022. Source: US FDA. Licensed CC0.

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