CoolFit ZELTIQ Vacuum Applicator
Medical device recall Z-1350-2022. 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
- 2,684 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?
CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000
2,684 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
CoolCurve REF: BRZ-AP1-066-000 BRZ-AP1-064-000_R UDI-DI: 00816417020216 Serial Numbers: V0662016146015 V0662016146014 V0662016146010 V0662016146007 V0662016146002 V0662016145016 V0662016145015 V0662016145010 V0662016145009 V0662016145008…
Every code shown here, 1,993 characters
CoolCurve REF: BRZ-AP1-066-000 BRZ-AP1-064-000_R UDI-DI: 00816417020216 Serial Numbers: V0662016146015 V0662016146014 V0662016146010 V0662016146007 V0662016146002 V0662016145016 V0662016145015 V0662016145010 V0662016145009 V0662016145008 V0662016145005 V0662016145004 V0662016145002 V0662016144019 V0662016144017 V0662016144016 V0662016144015 V0662016144014 V0662016144012 V0662016144009 V0662016144007 V0662016144003 V0662016140038 V0662016140037 V0662016140036 V0662016140035 V0662016140033 V0662016140032 V0662016140031 V0662016140030 V0662016140029 V0662016140028 V0662016140027 V0662016140024 V0662016140023 V0662016140021 V0662016140020 V0662016140018 V0662016140017 V0662016140014 V0662016140013 V0662016140011 V0662016140009 V0662016140007 V0662016140004 V0662016140003 V0662016140002 V0662016140001 V0662016137020 V0662016137019 V0662016137018 V0662016137016 V0662016137015 V0662016137014 V0662016137013 V0662016137012 V0662016137011 V0662016137010 V0662016137008 V0662016137006 V0662016137004 V0662016137001 V0662016123020 V0662016123017 V0662016123016 V0662016123009 V0662016123007 V0662016123006 V0662016123005 V0662016123003 V0662016123002 V0662016120020 V0662016120019 V0662016120018 V0662016120015 V0662016120011 V0662016120010 V0662016120009 V0662016120008 V0662016120007 V0662016120004 V0662016120003 V0662016113020 V0662016113019 V0662016113017 V0662016113015 V0662016113014 V0662016113013 V0662016113012 V0662016113010 V0662016113009 V0662016113008 V0662016113007 V0662016113006 V0662016113005 V0662016113004 V0662016113003 V0662016113002 V0662016113001 V0662016112020 V0662016112018 V0662016112017 V0662016112016 V0662016112014 V0662016112009 V0662016105014 V0662016105013 V0662016105010 V0662016105007 V0662016105006 V0662016105005 V0662016105004 V0662016105003 V0662016105001 V0662016104020 V0662016104019 V0662016104018 V0662016104016 V0662016104015 V0662016104014 V0662016104013 V0662016104012 V0662016104010 V0662016104009 V0662016104008 V0662016104007 V0662016104006…
FDA’s list runs to 40,302 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 40,302 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.