Angiodynamics recalls IsoLoc Prostate Immobilization Balloon Kit (ISO-100) due to mislabeling causing potential wrong size use. Affected units have specific lot numbers and UDI codes.
A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of 100cc/ml but the inner pouch identifies the product as an ISO-60 (fill volume of 60cc/ml).
Take action
Contact the company
📍Recalling firmAngiodynamics, Inc.603 Queensbury Ave · Queensbury, NY 12804-7619
“Angiodynamics IsoLoc Prostate Balloon Kit Mislabeled - Risk of Wrong Size.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55039-angiodynamics-isoloc-prostate-balloon-kit-mislabeled-risk-of-wrong-size. Based on FDA recall #Z-2267-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2267-2024%22&limit=1).
The FDA announced on May 21, 2024, that Angiodynamics, Inc. is recalling the IsoLoc Prostate Immobilization Treatment Balloon Device Kit (Catalog/UPN: ISO-100) due to mislabeling hazards. The affected balloons are incorrectly identified as having a 60cc/ml fill volume instead of the actual 100cc/ml capacity.
Distribution: US Nationwide in AZ, FL, IL, MO, MS, NJ, NM, NY, PA, TX, WI
The hazard
A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of 100cc/ml but the inner pouch identifies the product as an ISO-60 (fill volume of 60cc/ml).
Context
GovInfoNow's records show Angiodynamics, Inc. has 18 other recalls on record since 2017-06-05. Recent brand recalls include the AccuVu Catheter Recall (2026-03-03), the IsoLoc Prostate Balloon Kit Mislabeled with Incorrect Fill Volume (2025-02-04), and the Auryon Laser System Recall (2024-11-25). Other recent recalls of similar products include Olympus Nephro-EZDilate Catheter Kit: Incorrect Size Risk (2025-10-17), Olympus EZDilate Balloon Dilator Recall: Incorrect Inflation Chart Label Risk (2026-08-19), and Diversatek Viper 3-Stage Balloon Dilator Recall: Incorrect Part Numbers Risk Injury (2026-03-18).
How to tell if you have this one
Check the box UDI code (10851546007100) and pouch UDI code (00851546007103) for the affected batch. The lot number is 5402 for this specific mislabeled batch.
Brand
Angiodynamics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Codes
Verify the box UDI code (10851546007100) and pouch UDI code (00851546007103) to confirm if the product is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 11 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AZ, FL, IL, MO, MS, NJ, NM, NY, PA, TX, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Florida, Illinois, Mississippi, Missouri, New Jersey, New Mexico, New York, Pennsylvania, Texas, Wisconsin.
Recall timeline
FDA published this recall 50 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-2267-2024 (May 21, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2267-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.