Hologic, Inc Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
Brand
Hologic, Inc
Lot Codes / Batch Numbers
UDI-DI: 15420045504066 Lot Number: E22H19RM
Products Sold
UDI-DI: 15420045504066 Lot Number: E22H19RM
Hologic, Inc is recalling Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue due to The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
Recommended Action
Per FDA guidance
Hologic issued Urgent Medical Device Correction letter on 5/2/23. Letter states reason for recall, health risk and action to take: " Please properly dispose of any product(s) from this lot you currently have in your inventory. You will be issued a credit on your account for the affected product(s). If you wish to reorder product, please place a new order via your preferred procurement method. " Complete the online Customer Confirmation Form using the link below within 3 business days of receiving this notice. Replying promptly will confirm your receipt of the notification and prevent you from receiving repeat notices. o www.novasyte.com/hologic/sertera-2023 " Hologic has partnered with IQVIA to conduct follow-up communications should no response be received to this letter. . If you have any questions, please do not hesitate to reach out to Technical Support at BreastHealth.Support@hologic.com
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