B & K Medical Systems, Inc. B-K Medical Intraoperative Transducer Type 8814, diagnostic ultrasound transducer, B-K Medical Systems, Inc., Wilmington, MA 01887 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
B-K Medical Intraoperative Transducer Type 8814, diagnostic ultrasound transducer, B-K Medical Systems, Inc., Wilmington, MA 01887
Brand
B & K Medical Systems, Inc.
Lot Codes / Batch Numbers
Serial Numbers: 1864742, 1869148, 1869619, 1870824, 1870825, 1872061, and 1875317.
Products Sold
Serial Numbers: 1864742, 1869148, 1869619, 1870824, 1870825, 1872061, and 1875317.
B & K Medical Systems, Inc. is recalling B-K Medical Intraoperative Transducer Type 8814, diagnostic ultrasound transducer, B-K Medical Syste due to Crack: Incomplete glue joint in the device housing may affect electrical safety or sterilization.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Crack: Incomplete glue joint in the device housing may affect electrical safety or sterilization.
Recommended Action
Per FDA guidance
B-K Medical issued letter notification on 1/23/08 to accounts via Fed Ex, advising them not to use the unit until a representative can inspect and exchange, if unit is found defective. Instructions are also provided to continue use of the device with a sterile cover until site visit.
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 noticeDistribution
As reported by FDA
MA, MI, OR, PA, TX
Page updated: Jan 10, 2026