Hologic recalls Sertera-14 biopsy devices due to risk of inner needle separating from hub, potentially causing dislodgement. Affected units include specific model numbers and lot codes.
Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
Hologic is recalling Sertera-14 biopsy devices because the inner needle can separate from the hub during use, leading to dislodgement. This could cause injury if the needle moves unexpectedly during medical procedures.
The inner needle can separate from the hub during use, creating a longer throw or dislodging the needle. This poses a risk of unintended movement during medical procedures, which could lead to injury.
Medical professionals using the Sertera-14 biopsy device are most at risk. Patients undergoing procedures with this device may also be affected if the device malfunctions.
Check for model number Sertera-14 on the device. Affected units have specific lot numbers listed in the recall notice, including E23B23RL through E23L28RD and others.
Look for the model number Sertera-14 on the device to confirm if it is affected.
Reach out to Hologic for guidance on next steps if the device is affected.
The recall states that the inner needle can separate from the hub, creating a risk of dislodgement during use. Affected devices should not be used until further instructions are received.
Check the model number and lot numbers listed in the recall notice. Contact Hologic for specific instructions if the device is affected.
Yes, the inner needle can separate from the hub, potentially causing dislodgement during medical procedures, which could lead to injury.
We’ve drafted a message you can send Hologic to request your refund or repair — edit it as you like.
Subject: Recall Z-1170-2025 — Hologic Hologic Hello, I own a Hologic that is covered by recall Z-1170-2025 from Hologic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
