FDA Medical Device Recalls (openFDA)
Angiodynamics, Inc.: IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
- Recall number
- Z-2267-2024
- Recalling firm
- Angiodynamics, Inc.
- Product
- IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
- Status
- Open, Classified
- Initiated
- 2024-05-21
- Posted
- 2024-07-03
- Terminated
- not on file
- Reason
- 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).
- Root cause
- Under Investigation by firm
- Action
- On May 21, 2024 URGENT VOLUNTARY MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: IMMEDIATELY: 1. Stop using the product subject to recall. 2. Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). 3. Segregate this product in a secure location for return to AngioDynamics, Inc. 4. Forward a copy of this recall notification to all sites to which you have distributed affected product.
- Quantity
- 1,500 units (75 kits with 20 units per kit)
- Distribution
- US Nationwide distribution in the states of AZ, FL, IL, MO, MS, NJ, NM, NY, PA, TX, WI.
- Lot, serial or model codes
- UPN/Catalog: ISO-100; UDI/DI: 10851546007100 (Box) and 00851546007103 (Pouch); Lot number: 5402.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PCT
- Firm FEI
- 1319211
- Firm city
- Queensbury
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28