Z-2035-2023Class II

Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and...

Name: Z-2035-2023 Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and...
Creator: Hologic, Inc
Published: 2023-05-02
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2023-05-02 / Open, Classified / root cause: design

FDA source

Hologic, Inc began a recall of Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14 on 2023-05-02. FDA classified it as Class II and gives the reason as "The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2035-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-02
Posted: 2023-06-29
Recalling firm: Hologic, Inc.
Product: Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
Product code: KNW Instrument, Biopsy
Reason for recall: The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
Root cause tag: design
FDA root cause: Device Design
Action: 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]
Quantity in commerce: 756 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI: 15420045504066 Lot Number: E22H19RM

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2035-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2035-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-29

Product code KNW

K150169Class IISertera Biopsy DeviceHologic, Inc. / cleared 2015-08-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)