CoolCurve ZELTIQ Vaccum Applicator
Medical device recall Z-1348-2022. Published in FDA’s Enforcement Report on Jul 20, 2022.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 20, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 52 states named in where it went
- 703 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
CoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000
703 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
CoolCurve REF: BRZ-AP1-062-000 BRZ-AP1-062-000_R UDI-DI: 00816417021008 Serial Numbers: V06222012073001 V0622017039030 V0622016307004 V0622016196017 V0622012291003 V0622012289006 V0622012289004 V0622012289002 V0622012285005 V0622012285002…
Every code shown here, 1,994 characters
CoolCurve REF: BRZ-AP1-062-000 BRZ-AP1-062-000_R UDI-DI: 00816417021008 Serial Numbers: V06222012073001 V0622017039030 V0622016307004 V0622016196017 V0622012291003 V0622012289006 V0622012289004 V0622012289002 V0622012285005 V0622012285002 V0622012284009 V0622012284001 V0622012283003 V0622012282002 V0622012279006 V0622012279005 V0622012278001 V0622012277004 V0622012262002 V0622012258007 V0622012258002 V0622012255002 V0622012254001 V0622012250004 V0622012212001 V0622012210007 V0622012201001 V0622012193004 V0622012192004 V0622012178002 V0622012173001 V0622012170007 V0622012167003 V0622012167002 V0622012165008 V0622012163002 V0622012161005 V0622012161003 V0622012161002 V0622012160001 V0622012159007 V0622012159002 V0622012156004 V0622012153006 V0622012152001 V0622012150004 V0622012150002 V0622012150001 V0622012145003 V0622012145002 V0622012144001 V0622012143009 V0622012143008 V0622012143007 V0622012143006 V0622012143005 V0622012143002 V0622012140002 V0622012139005 V0622012139003 V0622012139002 V0622012139001 V0622012138003 V0622012137003 V0622012135003 V0622012135002 V0622012135001 V0622012130004 V0622012130003 V0622012129005 V0622012129002 V0622012129001 V0622012128005 V0622012128003 V0622012123002 V0622012123001 V0622012122001 V0622012121007 V0622012121006 V0622012121005 V0622012121004 V0622012121003 V0622012121002 V0622012121001 V0622012118002 V0622012118001 V0622012117001 V0622012116004 V0622012116002 V0622012116001 V0622012115005 V0622012115003 V0622012115002 V0622012114005 V0622012114003 V0622012114002 V0622012114001 V0622012111004 V0622012111001 V0622012110002 V0622012103002 V0622012103001 V0622012101001 V0622012100001 V0622012096003 V0622012096002 V0622012095004 V0622012095001 V0622012094001 V0622012093002 V0622012093001 V0622012088001 V0622012086003 V0622012086002 V0622012086001 V0622012083002 V0622012082003 V0622012082002 V0622012082001 V0622012081003 V0622012081002 V0622012081001 V0622012076002 V0622012074002 V0622012073002 V0622012072004 V0622012061001…
FDA’s list runs to 10,618 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
52 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 9, 2022.
- FDA classified it on Jul 11, 2022.
- FDA’s Enforcement Report published it on Jul 20, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Zeltiq Aesthetics, Inc, of Pleasanton, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 10,618 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.