IsoLoc recallZ-1391-2025 · Angiodynamics, Inc. · initiated Feb 4, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Angiodynamics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product is mislabeled with the incorrect fill volume.
FDA root cause category: Process control
What the company is doing
On February 4, 2025, URGENT VOLUNTARY MEDICAL DEVICE RECALL letters were sent to customers. ACTIONS TO BE TAKEN BY CONSIGNEES OF THE RECALL NOTIFICATION 1. IMMEDIATELY - Stop using the product subject to recall. - Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). - Segregate this product in a secure location for return to AngioDynamics, Inc. - Forward a copy of this recall notification to all sites to which you have distributed affected product. 2. Complete and return the Reply Verification Tracking Form. - Promptly complete, sign, and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return), following the directions on this page and the Reply Verification Tracking Form. * Email Reply Verification Tracking Form (preferred): [email protected] * Fax Reply Verification Tracking Form: 1-855-273-0519 (Fax #) Attn: ISO-60 Recall Coordinator - Call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 6:00 p.m. EST (Monday Friday) to obtain a replacement or credit for your returned product. - Report any Adverse reactions or quality problems associated with recalled devices to US FDA via MedWatch Adverse Event Reporting program either online, by regular mail or by fax. 3. Package and Return the Recalled Product. - Package any product that is being returned in an appropriate shipping box. - Write the RMA number (provided on the Recall Verification Tracking Form) on the RMA reference sticker and affix the sticker to the outside of the shipping box. - Contact AngioDynamics Inc. by phone or email (above contact) for shipping labels for returning the device. - Seal the box and return to: AngioDynamics, Inc. 24 Native Drive Queensbury, NY 12804 Attn: ISO-60 Recall Coordinator
Recall details
- Recall number
- Z-1391-2025
- Status
- Open, Classified
- Initiated by the company
- Feb 4, 2025
- Posted by the FDA
- Mar 18, 2025
- Recalling firm
- Angiodynamics, Inc.
- Quantity
- 1,800 units
- Product code
- PCT
- Distribution
- US Nationwide distribution in the states of AZ, DC, FL, TN, TX, VA, WI.
Product description
IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Code information (models, lots, serial numbers)
UPN/Catalog Number: ISO-60; UDI-DI: 00851546007219; Batch/Lot No.: 5694;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- IsoLoc ISO-60Radiadyne, L.L.C. · Prostate Immobilizer Rectal Balloon1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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