IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Summary
The FDA issued a Class II for IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/C by Angiodynamics, Inc.. Reason: Product is mislabeled with the incorrect fill volume..
Details
Source
Device Recall
External ID
Z-1391-2025
Action Date
2025-03-26
Status
Ongoing
Category
device
Product Description
IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Lot/Code Info: UPN/Catalog Number: ISO-60; UDI-DI: 00851546007219; Batch/Lot No.: 5694;
Quantity Affected: 1,800 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-04
Company
Queensbury, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 195 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Angiodynamics, Inc. has 73 FDA actions in our database, including 64 recalls and 9 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Angiodynamics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Angiodynamics, Inc. have FDA actions?
Angiodynamics, Inc. has 73 FDA actions in our database, including 64 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1391-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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