CoolCore ZELTIQ Vacuum Applicator
Medical device recall Z-1347-2022. 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
- 3,054 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?
CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000
3,054 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
CoolCore REF: BRZ-AP1-063-000 BRZ-AP1-063-000_F BRZ-AP1-063-000_K BRZ-AP1-063-000_R UDI-DI: 00816417020179 Serial Numbers: V0632018051020 V0632018051019 V0632018051018 V0632018051013 V0632018051009 V0632018051008 V0632018044020…
Every code shown here, 1,998 characters
CoolCore REF: BRZ-AP1-063-000 BRZ-AP1-063-000_F BRZ-AP1-063-000_K BRZ-AP1-063-000_R UDI-DI: 00816417020179 Serial Numbers: V0632018051020 V0632018051019 V0632018051018 V0632018051013 V0632018051009 V0632018051008 V0632018044020 V0632018024017 V0632018024002 V0632017292006 V0632017117013 V0632017108003 V0632017108001 V0632017100014 V0632016197018 V0632016140020 V0632016140019 V0632016140018 V0632016140017 V0632016140016 V0632016140015 V0632016140014 V0632016140012 V0632016140011 V0632016140008 V0632016140007 V0632016140006 V0632016140004 V0632016140003 V0632016140002 V0632016140001 V0632016139020 V0632016139019 V0632016139016 V0632016139015 V0632016139014 V0632016139013 V0632016139012 V0632016139011 V0632016139009 V0632016139008 V0632016139007 V0632016139006 V0632016139005 V0632016139004 V0632016139003 V0632016139001 V0632016133019 V0632016133018 V0632016133016 V0632016133015 V0632016133011 V0632016133009 V0632016133007 V0632016133004 V0632016133003 V0632016132017 V0632016132016 V0632016132015 V0632016132013 V0632016132012 V0632016132011 V0632016132010 V0632016132009 V0632016132008 V0632016132007 V0632016132006 V0632016132004 V0632016132003 V0632016132001 V0632016131020 V0632016131019 V0632016131018 V0632016131017 V0632016131014 V0632016131013 V0632016131012 V0632016131011 V0632016131009 V0632016131008 V0632016131007 V0632016131006 V0632016131005 V0632016131003 V0632016131002 V0632016127020 V0632016127019 V0632016127016 V0632016127015 V0632016127014 V0632016127012 V0632016127006 V0632016127005 V0632016126019 V0632016126017 V0632016126016 V0632016126015 V0632016126010 V0632016126004 V0632016120019 V0632016120013 V0632016120007 V0632016118019 V0632016118018 V0632016118017 V0632016118016 V0632016118015 V0632016118014 V0632016118013 V0632016118011 V0632016118010 V0632016118009 V0632016118008 V0632016118007 V0632016118006 V0632016118004 V0632016118003 V0632016118002 V0632016118001 V0632016116020 V0632016116019 V0632016116018 V0632016116017 V0632016116016 V0632016116015…
FDA’s list runs to 45,811 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 45,811 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.