Angiodynamics IsoLoc Prostate Balloon Kit Mislabeled with Incorrect Fill Volume
Angiodynamics recalls IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit (UPN/ISO-60) due to mislabeling with incorrect fill volume. Consumers should check product details to determine if affected.
Lower-risk recall
Product is mislabeled with the incorrect fill volume.
Contact the company
What happened, in plain English
Angiodynamics is recalling its IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit (UPN/ISO-:60) because it's mislabeled with the wrong fill volume. This could lead to improper use during medical procedures if the fill volume is incorrect. Read more at govinfonow.com/recall/52978-angiodynamics-isoloc-prostate-balloon-kit-mislabeled-with-incorrect-fill-volume.
Source Summary by GovInfoNow · govinfonow.com/recall/52978-angiodynamics-isoloc-prostate-balloon-kit-mislabeled-with-incorrect-fill-volume · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1391-2025
Cite this page
“Angiodynamics IsoLoc Prostate Balloon Kit Mislabeled with Incorrect Fill Volume.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52978-angiodynamics-isoloc-prostate-balloon-kit-mislabeled-with-incorrect-fill-volume. Based on FDA recall #Z-1391-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1391-2025%22&limit=1).
Why it’s dangerous
The product is mislabeled with the incorrect fill volume, which could lead to improper use during medical procedures if the fill volume is not accurate. This might cause ineffective treatment or complications during prostate procedures.
Who’s affected
Patients using this prostate immobilization treatment balloon kit for medical procedures. Medical professionals who handle the kit are most at risk of incorrect application.
How to tell if you have this one
Check for UPN/Catalog Number: ISO-60 on the product. The UDI-DI is 00851546007219 and Batch/Lot No. is 5694. This kit is sold for medical use in the U.S.
- Brand
Angiodynamics- Category
Medical device
What to do — step by step
Check Product Details
Verify the UPN/Catalog Number (ISO-60), UDI-DI (00851546007219), and Batch/Lot No. (5694) to confirm if the product is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 6 states.
FDA distribution: “US Nationwide distribution in the states of AZ, DC, FL, TN, TX, VA, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, District of Columbia, Florida, Tennessee, Texas, Virginia, Wisconsin.
Recall timeline
FDA published this recall 50 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1391-2025 (February 4, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1391-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.