Pleasanton, CA, United States
Calyxo, Inc. recalls
1 recall recorded since 2018, most recently on 19 February 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)1
Ongoing Class I Medical devices
- Recall started
- 19 February 2025
- Reason
- Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions, for patients with high viscosity fluid in the kidney, not to continue providing fluid inflow in the presence of unresolved slow or absent fluid outflow because this can create intrarenal pressure imbalance, and lead to excessive intrarenal pressure.
- Distribution
- US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1396-2025
- CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.