Medline recalls certain CRANIOTOMY PACKs with non-sterile Mastisol components that could cause patient infections if used without proper sterility checks.
A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.
Medline is recalling specific CRANIOTOMY PACKs that contain a non-sterile Mastisol component. This poses a risk of patient infection if the user mistakenly assumes the product is sterile during use.
The recalled packs include a non-sterile Mastisol component that was incorrectly placed in the non-sterile portion of sterile kits. If healthcare workers assume the product is sterile during use, it could lead to patient infections.
Healthcare professionals using the recalled CRANIOTOMY PACKs for surgical procedures. Patients undergoing surgery with these packs are at risk of infection if the product is not properly sterilized.
Check for pack number DYNJ46552O, lot numbers 24ADB788, 23LDA936, 23JDB278, or 23HDA872. The product is sold under the brand Medline Industries.
Identify the pack number and lot numbers listed in the recall notice to confirm if your CRANIOTOMY PACK is affected.
No, the recalled CRANIOTOMY PACKs contain a non-sterile component that could cause patient infections if used without proper sterility checks.
Check the pack number and lot numbers to see if your CRANIOTOMY PACK is affected. If it is, contact Medline Industries for further instructions.
Look for pack number DYNJ46552O or lot numbers 24ADB788, 23LDA936, 23JDB278, or 23HDA872.
We’ve drafted a message you can send Medline Industries to request your refund or repair — edit it as you like.
Subject: Recall Z-3069-2024 — Medline Industries Medline Industries Hello, I own a Medline Industries that is covered by recall Z-3069-2024 from Medline Industries. 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.
