Zeltiq Aesthetics, Inc recalls CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000
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.
Read the official notice →- Date
- 2022-07-20
- Country
- United States
- Brand
- Zeltiq Aesthetics, Inc
- Product
- CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000
- Classification
- Class II
- Units
- U.S. AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
Other drugs & medical recalls in the United States
- 2022-07-20
USIsopure Corp recalls Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
Isopure received a report of a hazardous incident involving a device which had experienced an electrical short that resulted in a thermal event, damaging some of the device components. The firm is alerting customers to…
FDA · DeviceIsopure CorpDomestic distribution to AL AZ CO DE FL GA IN KS KY LA MA MD ME MN MO NC NY OK…Official notice →- US
Medtronic MiniMed recalls MiniMed 640G Insulin Pump (O.U.S. Version)
Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of the insulin infusion pumps.
FDA · DeviceMedtronic MiniMedU.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…Official notice → - US
Spectranetics Corporation recalls Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
The LAS-100 Laser system may detect an inoperable hardware component during power up, which results in an error code and the system not being operable until code is cleared.
FDA · DeviceSpectranetics CorporationUS: AR AZ CA CO CT FL GA HI IA IL IN KS LA MA MD ME MI MN MO NC NJ NY OK PA TN…Official notice → - US
Philips Medical Systems DMC GmbH recalls DigitalDiagnost 4 High Performance. radiography and fluoroscopy system
Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the…
- US
Latin Foods Market recalls Arti King Refozado con Ortiga y Omega 3 Tablets, 100-count bottles, Hecho en Mexico por: "PLANTAS MEDICINALES DE MEXICO", Melchor Ocampo…
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and dexamethasone.
- US
TMC Acquisition LLC dba Tailor Made Compounding recalls GAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Lack of Assurance of Sterility
FDA · DrugTMC Acquisition LLC dba Tailor Made CompoundingNationwide USA and Puerto RicoOfficial notice →