FDA Medical Device Recalls (openFDA)
Bk Medical: Single-use sterile puncture attachment UA1256-U used with the BK Medical Ultrasounds: Diagnostic Ultrasound scanner Pro Focus 2202 and Diagnostic Ultrasound Transducer 8667 Diagnostic Ultrasound scanner 2102 and Diagnostic Ultrasound Transducer 8667 Diagnostic Ultrasound scanner 2101 and Diagnostic Ultrasound Transducer 8667 Performing ultrasound guided biopsies of the prostate.
- Recall number
- Z-0504-2009
- Recalling firm
- Bk Medical
- Product
- Single-use sterile puncture attachment UA1256-U used with the BK Medical Ultrasounds: Diagnostic Ultrasound scanner Pro Focus 2202 and Diagnostic Ultrasound Transducer 8667 Diagnostic Ultrasound scanner 2102 and Diagnostic Ultrasound Transducer 8667 Diagnostic Ultrasound scanner 2101 and Diagnostic Ultrasound Transducer 8667 Performing ultrasound guided biopsies of the prostate.
- Status
- Terminated
- Initiated
- 2008-09-08
- Posted
- 2008-12-16
- Terminated
- 2016-01-29
- Reason
- No 510k approved
- Root cause
- Other
- Action
- BK Medical notified accounts via a Recall Notice letter dated 9/03/08 to inform customers of the unapproved status and to remove the device from use and it will be replaced with B-K Medical's reusable metal guide UA1256. Customers were to fill out the attached "Reply Form" and return it via fax or the postage paid envelope. Any questions should be directed to B-K Medical Systems, Inc. at 1-800-876-7226.
- Quantity
- 664 pieces
- Distribution
- Nationwide Distribution --- including states of AR, CA, CO, CT, IL,IN, OK. OH, MA, MS, MD, NC, and NY.
- Lot, serial or model codes
- All lot numbers
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 3003705156
- Firm city
- Iierlev
- Firm state
- not on file
- Firm country
- Denmark
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