CoolSculpting Elite System The CoolSculpting System SW release 2 — Class II medical device recall Z-2383-2021
Terminated recall by Zeltiq Aesthetics, Inc, reported 2021-09-08, distributed in AL, AR, AZ, CA, CO, CT, FL, GA…. An incorrect error messaging system that could potentially lead to: 1) Reporting a thermal event error causing
| Recall number | Z-2383-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zeltiq Aesthetics, Inc, Pleasanton, CA, United States |
| Recall initiated | 2021-07-05 |
| Classified | 2021-08-27 |
| Reported by FDA | 2021-09-08 |
| Terminated | 2023-11-09 |
| Distributed | AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Countries outside the US | DE, ES, FR, GB, HK, IT, KR, NL, NO, PT, SE, SG |
| UPC / GTIN / UDI-DI | 00012020134009, 00012020142004, 00012020148006, 00012020148013, 00012020149003, 00012020149010, 00012020160008, 00012020160015, 00012020162002, 00012020168004, 00012020168011, 00012020170007, 00012020181003, 00012020188002, 00012020190005, 00012020190012, 00012020191002, 00012020198001, 00012020219003, 00012020226001, 00012020246016, 00012020253007, 00012020260005, 00012020273012, 00012020283004 and 68 more |
| Serial numbers | D012020134001, D012020134009, D012020134014, D012020134015, D012020142001, D012020142002, D012020142003, D012020142004, D012020142005, D012020142006, D012020142007, D012020142012, D012020142013, D012020142014, D012020142015, D012020142016, D012020148001, D012020148002, D012020148003, D012020148004, D012020148005, D012020148006, D012020148007, D012020148010, D012020148011 and 475 more |
Product
CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2
Reason for recall
An incorrect error messaging system that could potentially lead to: 1) Reporting a thermal event error causing a user to re-treating the affected anatomic area within 24 hours, 2) Not reporting a thermal event or any other error codes causing a user to continue treating without being aware that a thermal event has occurred.
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-2383-2021. 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.