Reported Mar 26, 2025 · Ongoing
IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Angiodynamics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Angiodynamics, Inc. · 603 Queensbury Ave · Queensbury, NY · 12804-7619
Is this the product you have?
- IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit
- UPN/Catalog NumberISO-60
- Lot codes and dates
- UPN/Catalog NumberISO-60
- UDI-DI
00851546007219Batch/Lot No.: 5694
- Amount recalled
- 1,800 units
Where it was sold
Why it was recalled
Product is mislabeled with the incorrect fill volume.
This product could cause temporary or reversible health problems — stop using it.
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