Z-2267-2024 Class II Ongoing
FDA device recall Z-2267-2024 was initiated by Angiodynamics, Inc. on May 21, 2024 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 1,500 units (75 kits with 20 units per kit).
Recall Details
- Product Type
- Devices
- Report Date
- Jul 10, 2024
- Initiation Date
- May 21, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,500 units (75 kits with 20 units per kit)
Product Description
IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
Reason for Recall
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).
Distribution Pattern
US Nationwide distribution in the states of AZ, FL, IL, MO, MS, NJ, NM, NY, PA, TX, WI.
Code Information
UPN/Catalog: ISO-100; UDI/DI: 10851546007100 (Box) and 00851546007103 (Pouch); Lot number: 5402.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2267-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026