CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000 — Class II medical device recall Z-1347-2022
Ongoing recall by Zeltiq Aesthetics, Inc, reported 2022-07-20, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint r
| Recall number | Z-1347-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zeltiq Aesthetics, Inc, Pleasanton, CA, United States |
| Recall initiated | 2022-06-09 |
| Classified | 2022-07-11 |
| Reported by FDA | 2022-07-20 |
| Distributed | 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, WY |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BO, CA, CH, CN, CY, CZ, DE, DK, ES, FI, FR, GB, GR, GT, HK, ID, IE, IL, IN, IT, JO, JP, KR, KW, LB, LU, LV, MX, NL, NO, PA, PE, PH, PL, PT, QA, SA, SE, SG, TH, TR, TW, UY, VE, ZA |
| Quantity | 3,054 units |
| UPC / GTIN / UDI-DI | 00063201148001, 00632010090001, 00632010163002, 00632010195003, 00632010217002, 00632010272001, 00632010285001, 00632010300001, 00632010309004, 00632010313001, 00632010348003, 00632011006001, 00632011018004, 00632011021004, 00632011025002, 00632011028003, 00632011034004, 00632011038002, 00632011052008, 00632011054002, 00632011066005, 00632011073003, 00632011083002, 00632011096002, 00632011097009 and 278 more |
| Serial numbers | V0632012305006, V0632012305008, V0632012305010, V0632012306001, V0632012306002, V0632012306003, V0632012306004, V0632012306007, V0632012306008, V0632012306010, V0632012306011, V0632012306012, V0632012307001, V0632012310001, V0632012310005, V0632012311001, V0632012311002, V0632012311004, V0632012311005, V0632012311006, V0632012312001, V0632012312002, V0632012312003, V0632012312004, V0632012312005 and 475 more |
| Model numbers | BRZ-AP1-063-000 |
Product
CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1347-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.