Suros Surgical Systems Inc. ATEC Breast Biopsy and Excision System Needle Guide, 9 GA, sterile, in packages of 5, Ref ATEC NG09. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ATEC Breast Biopsy and Excision System Needle Guide, 9 GA, sterile, in packages of 5, Ref ATEC NG09.
Brand
Suros Surgical Systems Inc.
Lot Codes / Batch Numbers
Needle guide lot numbers 603006, exp. 3/1/2008, and 602013, exp. 2/6/2008.
Products Sold
Needle guide lot numbers 603006, exp. 3/1/2008, and 602013, exp. 2/6/2008.
Suros Surgical Systems Inc. is recalling ATEC Breast Biopsy and Excision System Needle Guide, 9 GA, sterile, in packages of 5, Ref ATEC NG09 due to Lack of assurance of sterility, as package may have a seal defect (improperly sealed primary packaging).. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of assurance of sterility, as package may have a seal defect (improperly sealed primary packaging).
Recommended Action
Per FDA guidance
Consignees were notified telephone and letter dated 5/25/06 to stop using the recalled product and to return it to the firm. The recall was extended to an additional lot by phone calls to each customer between Julne 26 and 30, 2006 and by letter dated 6/19/06 and sent between June 28 and July 7, 2006.
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