DIXI Medical recalls Microdeep Depth Electrodes due to potential packaging deformation that could compromise sterile barrier. Affected units have UDI 036645390:000077. Stop using if packaging may be damaged.
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
DIXI Medical is recalling Microdeep Depth Electrodes because the internal packaging might deform when removed from the Tyvek bag, risking a broken sterile barrier. This could lead to infection or contamination during medical use. The recall affects specific units with the UDI code 03664539000077.
The electrode's packaging could deform when taken out of the Tyvek bag, potentially breaking the sterile barrier. This might allow contamination or infection during medical procedures. The risk is low but could happen if the packaging is damaged.
Medical professionals using the electrode for brain signal monitoring are most at risk. Patients receiving the device during procedures may also be affected if the sterile barrier is compromised.
Check for the UDI code 03664539000077 on the packaging. The device is a smooth electrode 0.8 mm in diameter used for brain signal monitoring.
Inspect the internal packaging for signs of deformation or damage before use.
The recall indicates a potential risk if packaging deforms, but the device is generally safe if packaging remains intact.
Check the UDI code on the packaging; if it matches 03664539000077, stop using it and contact DIXI Medical for guidance.
Look for visible deformities or gaps in the blister pack that might compromise the sterile barrier.
We’ve drafted a message you can send DIXI Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0537-2022 — DIXI Medical DIXI Medical Hello, I own a DIXI Medical that is covered by recall Z-0537-2022 from DIXI 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.
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.
