IsoLoc Prostate Treatment Balloon Devices Recalled for Incorrect Fill Volume Labeling
Angiodynamics is recalling 1,800 units of IsoLoc prostate treatment balloons due to incorrect fill volume labeling. The affected devices were distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall involving labeling error with no reported hospitalizations or adverse events. Meets criteria for Moderate severity: minor labeling errors without reported injury.
Plain-English summary
Angiodynamics, Inc. is recalling the IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit (Catalog Number ISO-60), affecting 1,800 units distributed nationwide in Arizona, District of Columbia, Florida, Tennessee, Texas, Virginia, and Wisconsin.
The affected devices are mislabeled with an incorrect fill volume specification. These devices are identified by Lot Number 5694 and UDI-DI 00851546007219.
Healthcare facilities and clinicians who have received affected devices should immediately contact Angiodynamics, Inc. for further instructions and guidance on managing affected inventory.
The FDA has classified this as a Class II recall.
The recalled product
- Product
- IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
- Manufacturer
- Angiodynamics, Inc.
- Category
- Medical Device — Urology
- Hazard
- Affected units
- 1,800
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UPN/Catalog Number: ISO-60
- UDI-DI: 00851546007219
- Batch/Lot No.: 5694
Distribution
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