Civco Medical recalls BX2 Needle Guide (Part 644-094) due to risk of pinhole breaches in ultrasound transducers during assembly. Affected units have specific lot numbers and UDI-DI codes.
During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cover when latching the guide in place.
Civco Medical is recalling BX2 Needle Guides (Part 644-094) because improper assembly can cause small holes in ultrasound transducers. This could lead to fluid leaks or infections during medical procedures.
The needle guide's tight fit can create pinholes in the ultrasound transducer cover when attached. This breach could allow bodily fluids to leak into the transducer, potentially causing infections during medical procedures.
Medical professionals using the BX2 Needle Guide for ultrasound procedures are most at risk. Patients undergoing procedures with this device may face infection risks if transducers develop pinholes.
Check for the part number 644-094 on the BX2 Needle Guide. Affected units have specific lot numbers listed in the recall notice and UDI-DI code 00841436120050.
Look for the part number 644-094 and UDI-DI code 00841436120050 on the device.
The needle guide's tight fit can cause pinholes in the ultrasound transducer cover during assembly, potentially leading to fluid leaks and infection risks.
Check the part number and UDI-DI code to see if your unit is affected. If it is, contact Civco Medical for further instructions.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Civco Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1892-2025 — Civco Medical Civco Medical Hello, I own a Civco Medical that is covered by recall Z-1892-2025 from Civco Medical. 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.
