FDA Medical Device Recalls (openFDA)
Urologix, Inc.: Urologix Microwave Delivery System 2.5 - 3.5 For use with prostatic urethra lengths of 2.5-3.5 cm only. Model TA1321D.
- Recall number
- Z-0721-2007
- Recalling firm
- Urologix, Inc.
- Product
- Urologix Microwave Delivery System 2.5 - 3.5 For use with prostatic urethra lengths of 2.5-3.5 cm only. Model TA1321D.
- Status
- Terminated
- Initiated
- 2007-03-16
- Posted
- 2007-04-05
- Terminated
- 2007-05-25
- Reason
- The catheter in the kit matches the description on the kit and pouch label; however, an incorrect label was placed onto the catheter during manufacturing.
- Root cause
- Other
- Action
- A letter dated 3/16/07 was FedEx overnight to consignees. The letter described the product, problem and gave instructions for returning and replacing the affected product.
- Quantity
- 21
- Distribution
- Nationwide and the Netherlands.
- Lot, serial or model codes
- Individual catheter lot number KG001346 for model TA1321D. Kit box lot number KGP111105.
- 510(k) numbers
- not on file
- PMA numbers
- ["P970008"]
- Product code
- MEQ
- Firm FEI
- 3000718675
- Firm city
- Minneapolis
- Firm state
- MN
- 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