Z-1170-2025Class II

Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14...

Name: Z-1170-2025 Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14...
Creator: Hologic, Inc
Published: 2025-01-15
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2025-01-15 / Open, Classified / root cause: manufacturing process

FDA source

Hologic, Inc began a recall of Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument... on 2025-01-15. FDA classified it as Class II and gives the reason as "Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1170-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-15
Posted: 2025-02-13
Recalling firm: Hologic, Inc.
Product: Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A
Product code: KNW Instrument, Biopsy
Reason for recall: Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On January 15, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Our goal is to create as little disruption to your practice as possible. Below outlines the next steps for customers with affected product(s): " Please quarantine any product(s) from the impacted lots you currently have in your inventory. Impacted lots can be returned through IQVIA as part of the voluntary recall. Please note that you will be issued a credit on your account for the affected product(s). " Refer to the Customer Response Form Instructions to identify your product inventory that is subject to this action. " Confirm receipt of this communication by completing the online Customer Response Form. Please complete and submit the online Customer Response Form even if you no longer have the affected product in inventory. Hologic has partnered with IQVIA to conduct follow up communications should no response be received to this letter. " Hologic will issue a Return Goods Authorization upon receipt of the Customer Response Form and the return of all affected products to Hologic. " If you wish to reorder product, please place a new order via your preferred procurement method. We value your business and thank you for your cooperation. If you have any questions about this communication, please contact [email protected] or 1-877-371-4372.
Quantity in commerce: 55,335 units
Distribution: Domestic: Nationwide Distribution
Product codes and lots: Model No- Sertera-14; UDI- 15420045504066; Lot Numbers: E23B23RL, E23B23RM, E23C07RD, E23C07RF, E23C31RC, E23D12RT, E23D12RU, E23D27RW, E23E03RJ, E23E12RT, E23E12RU, E23E29RL, E23E30RM, E23F02RG, E23F07RL, E23F07RM, E23F27R, E23F29RL, E23F29RM, E23F29RN, E23G12RK, E23G25R, E23G31RL, E23H02R, E23H02RA, E23H02RB, E23H28RA, E23H31RF, E23H31RG, E23K02RL, E23K10R, E23K10RA, E23K10RB, E23K31RU, E23L06RK, E23L10RB, E23L22RV, E23L28RB, E23L28RD, E23M21RV, E24A08RL, E24A08RM, E24A26RD, E24B01RF, E24B07RK, E24B22RC, E24B28R, E24B28RA, E24C07RA, E24C21R, E24D26RF, E24E02RD, E24E15RA, E24E22R, E24E22RA, E24E24RB.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1170-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1170-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-13

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)