Hologic recalls Sertera 14 Gauge Biopsy Devices due to potential needle detachment causing surgery delays. Affected devices have specific lot numbers and UDI-DI codes.
The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
Hologic is recalling Sertera 14 Gauge Biopsy Devices because the inner needle may detach during use, potentially delaying surgery. This could impact patients needing breast tissue or tumor biopsies.
The inner needle can detach or discharge during use, which might cause surgery to be delayed. This delay could affect treatment timing for patients needing biopsies of breast tissue or tumors.
Healthcare professionals using the Sertera device for breast biopsies are most at risk. Patients undergoing procedures with this device may experience delays.
Check for the model name 'Sertera 14 Gauge Biopsy Device' and lot number E22H19RM. The UDI-DI code 15420:0045504066 identifies affected units.
Identify the lot number and UDI-DI code on the device to confirm if it's affected.
The inner needle may detach or discharge during use, potentially causing surgery delays.
Check the lot number and UDI-DI code to see if it's affected. If it is, contact Hologic for further instructions.
The recall addresses potential surgery delays, not direct injury risks. The hazard does not mention injury.
We’ve drafted a message you can send Hologic to request your refund or repair — edit it as you like.
Subject: Recall Z-2035-2023 — Hologic Hologic Hello, I own a Hologic that is covered by recall Z-2035-2023 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.
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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.
