CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000
Reported: July 20, 2022 Initiated: June 9, 2022 #Z-1347-2022
Product Description
CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000
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.
Details
- Recalling Firm
- Zeltiq Aesthetics, Inc
- Units Affected
- 3,054 units
- 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, 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.
- Location
- Pleasanton, CA
Frequently Asked Questions
What product was recalled? ▼
CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000. Recalled by Zeltiq Aesthetics, Inc. Units affected: 3,054 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 20, 2022. Severity: Moderate. Recall number: Z-1347-2022.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11