Suros Surgical Systems Inc. Suros ATEC Breast Biopsy System handpiece (9 gauge cannula 12 centimeters in length with a 20 millimeter aperture) for use with the ATEC Breast Biopsy and Excision System, disposable, sterile; Part no. 0912-20. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Suros ATEC Breast Biopsy System handpiece (9 gauge cannula 12 centimeters in length with a 20 millimeter aperture) for use with the ATEC Breast Biopsy and Excision System, disposable, sterile; Part no. 0912-20.
Brand
Suros Surgical Systems Inc.
Lot Codes / Batch Numbers
Lot 611018.
Products Sold
Lot 611018.
Suros Surgical Systems Inc. is recalling Suros ATEC Breast Biopsy System handpiece (9 gauge cannula 12 centimeters in length with a 20 millim due to The handpiece package may have an incorrect part number on the inner package. Error could result in over-penetration of the biopsy needle.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The handpiece package may have an incorrect part number on the inner package. Error could result in over-penetration of the biopsy needle.
Recommended Action
Per FDA guidance
Consignees were notified by phone beginning on 12/15/06 and by follow-up letter dated 12/19/06.
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