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.
Product is mislabeled with the incorrect fill volume.
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.
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.
Patients using this prostate immobilization treatment balloon kit for medical procedures. Medical professionals who handle the kit are most at risk of incorrect application.
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.
Verify the UPN/Catalog Number (ISO-60), UDI-DI (00851546007219), and Batch/Lot No. (5694) to confirm if the product is affected.
The recall is due to mislabeling with incorrect fill volume, which could lead to improper use during medical procedures. However, the product itself is not inherently dangerous.
Check for UPN/Catalog Number: ISO-60, UDI-DI: 00851546007219, and Batch/Lot No.: 5694 on the product.
The recall does not specify a remedy, so check product details to confirm if affected. Contact your healthcare provider for guidance.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1391-2025 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1391-2025 from Angiodynamics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
