Sertera Biopsy Device recallZ-2035-2023 · Hologic, Inc · initiated May 2, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hologic, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
FDA root cause category: Device Design
What the company is doing
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 [email protected]
Recall details
- Recall number
- Z-2035-2023
- Status
- Open, Classified
- Initiated by the company
- May 2, 2023
- Posted by the FDA
- Jun 29, 2023
- Recalling firm
- Hologic, Inc
- Quantity
- 756 units
- Product code
- KNW
- FDA submissions
- K150169
- Distribution
- US Nationwide distribution.
Product description
Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
Code information (models, lots, serial numbers)
UDI-DI: 15420045504066 Lot Number: E22H19RM
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Sertera Biopsy Device Sertera-14Hologic, Inc. · INSTRUMENT, BIOPSY2 recalls14 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K150169 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Sertera Biopsy Device Sertera-12Hologic, Inc. · INSTRUMENT, BIOPSY2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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