CoolCurve+ ZELTIQ Vacuum Applicator
Medical device recall Z-1349-2022. 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
- 2,686 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 Vacuum Applicator REF BRZ-AP1-064-000
2,686 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
CoolCurve+ REF: BRZ-AP1-064-000 BRZ-AP1-064-000_R UDI-DI: 00816417020193 Serial Numbers: V0642017122012 V0642016285020 V0642016285018 V0642016173010 V0642016173009 V0642016173007 V0642016173005 V0642016173003 V0642016173002 V0642016173001…
Every code shown here, 1,994 characters
CoolCurve+ REF: BRZ-AP1-064-000 BRZ-AP1-064-000_R UDI-DI: 00816417020193 Serial Numbers: V0642017122012 V0642016285020 V0642016285018 V0642016173010 V0642016173009 V0642016173007 V0642016173005 V0642016173003 V0642016173002 V0642016173001 V0642016167020 V0642016167019 V0642016167018 V0642016167017 V0642016167015 V0642016167013 V0642016167011 V0642016167009 V0642016167007 V0642016167006 V0642016167002 V0642016167001 V0642016160019 V0642016160018 V0642016160017 V0642016160014 V0642016160013 V0642016160012 V0642016160009 V0642016160008 V0642016160005 V0642016160003 V0642016160002 V0642016127020 V0642016127019 V0642016127018 V0642016127017 V0642016127016 V0642016127014 V0642016127013 V0642016127011 V0642016127008 V0642016127006 V0642016127005 V0642016127004 V0642016127001 V0642016125019 V0642016125018 V0642016125017 V0642016125016 V0642016125015 V0642016125014 V0642016125013 V0642016125011 V0642016125010 V0642016125009 V0642016125008 V0642016125007 V0642016125006 V0642016125005 V0642016125003 V0642016124020 V0642016124019 V0642016124018 V0642016124017 V0642016124016 V0642016124005 V0642016124004 V0642016118036 V0642016118031 V0642016118026 V0642016118021 V0642016118017 V0642016118016 V0642016118015 V0642016118014 V0642016118013 V0642016118012 V0642016118009 V0642016118006 V0642016118005 V0642016118003 V0642016118002 V0642016118001 V0642016110020 V0642016110019 V0642016110018 V0642016110016 V0642016110015 V0642016110013 V0642016110012 V0642016110011 V0642016110010 V0642016110009 V0642016110008 V0642016110007 V0642016110006 V0642016110005 V0642016110004 V0642016110002 V0642016110001 V0642016109020 V0642016109019 V0642016109018 V0642016109016 V0642016109012 V0642016109011 V0642016109009 V0642016109008 V0642016109007 V0642016109006 V0642016109004 V0642016109003 V0642016109001 V0642016103020 V0642016103019 V0642016103010 V0642016103003 V0642016102019 V0642016102018 V0642016102017 V0642016102016 V0642016102015 V0642016102013 V0642016102011 V0642016102008 V0642016102002…
FDA’s list runs to 40,244 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 40,244 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
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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.