Bk Medical Mileparken 34 Iierlev Denmark 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Bk Medical Mileparken 34 Iierlev Denmark
Lot Codes / Batch Numbers
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Products Sold
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Bk Medical Mileparken 34 Iierlev Denmark is recalling Single-use sterile puncture attachment UA1256-U used with the BK Medical Ultrasounds: Diagnostic Ult due to No 510k approved. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
No 510k approved
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026