FDA recall Z-1391-2025

Angiodynamics, Inc. · Class II · device

Product

IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;

Reason for recall

Product is mislabeled with the incorrect fill volume.

Distribution

US Nationwide distribution in the states of AZ, DC, FL, TN, TX, VA, WI.

Key facts

Status
Ongoing
Initiation date
2025-02-04
Report date
2025-03-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Queensbury, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1391-2025