FDA Medical devices recall ·
IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit recall
- Recall number
- Z-1391-2025
- Date
- (initiated February 4, 2025)
- Company / brand
- Angiodynamics, Inc.
603 Queensbury Ave, Queensbury, NY, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,800 units
- Hazard tags
- Mislabeling
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Why was it recalled?
Product is mislabeled with the incorrect fill volume.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UPN/Catalog Number: ISO-60; UDI-DI: 00851546007219; Batch/Lot No.: 5694;
Distribution
US Nationwide distribution in the states of AZ, DC, FL, TN, TX, VA, WI.
States: Arizona District of Columbia Florida Tennessee Texas Virginia Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1391-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.