Device recall: CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000
FDA enforcement event 90331 is a device recall by Zeltiq Aesthetics, Inc of Pleasanton, CA, initiated 9 Jun 2022 and classified Class II, with 5 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Zeltiq Aesthetics, Inc has 2 enforcement events on this register, with a median of 5 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Zeltiq Aesthetics, Inc, Pleasanton, CA.
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1346-2022 | CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000 | 2,945 units | Class II | Ongoing | 20 Jul 2022 |
| Z-1347-2022 | CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000 | 3,054 units | Class II | Ongoing | 20 Jul 2022 |
| Z-1348-2022 | CoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000 | 703 units | Class II | Ongoing | 20 Jul 2022 |
| Z-1349-2022 | CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000 | 2,686 units | Class II | Ongoing | 20 Jul 2022 |
| Z-1350-2022 | CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000 | 2,684 units | Class II | Ongoing | 20 Jul 2022 |
Context
Other enforcement events for Zeltiq Aesthetics, Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 5 Jul 2021 | CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2 (88397) | Device | Class II | 1 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.