Zeltiq Aesthetics, Inc recalls
Every recall we track for Zeltiq Aesthetics, Inc — 6 in all, from 2021–2022 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
Recalls from Zeltiq Aesthetics, Inc peaked in 2022 (5); 6 since 2017. 17% rated “stop using now”.
All FDA recall records for Zeltiq Aesthetics, Inc since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 1 | 0 | 0 | 1 |
| 2022 | 1 | 2 | 2 | 0 | 5 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Zeltiq Aesthetics, Inc product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Zeltiq Aesthetics, Inc recalls
2 shown- Use cautionMedical device
Zeltiq Aesthetics, Inc recalls CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000
Zeltiq recalls CoolMax ZELTIQ Vacuum Applicators with specific serial numbers due to increased reports of Paradoxical Hyperplasia (HP) between 2019-2021. This condition involves abnormal tissue growth that may require medical attention.
ZeltiqJun 9, 2022 - Use cautionMedical device
Zeltiq Aesthetics, Inc recalls CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2
Zeltiq Aesthetics recalls CoolSculpting Elite System software versions 2.0 through 3.0.2 due to potential error messaging that could cause users to re-treat areas within 24 hours or miss thermal events.
Zeltiq AestheticsJul 5, 2021
Zeltiq Aesthetics, Inc recall questions
How many recalls has Zeltiq Aesthetics, Inc had?
6 recalls from Zeltiq Aesthetics, Inc are on record with U.S. safety agencies, from 2021–2022.
What is the most recent Zeltiq Aesthetics, Inc recall?
Zeltiq Aesthetics, Inc recalls CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000, dated Jun 9, 2022. Every Zeltiq Aesthetics, Inc recall is listed on this page, newest first.
What should I do if I have a recalled Zeltiq Aesthetics, Inc product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Zeltiq Aesthetics, Inc recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.