Advance Medical Designs recalls procedural kits with specific ultrasonic gel items due to mislabeling that could lead to incorrect use. Affected items include model numbers 28-EG103 through 28-EG197 with listed lot numbers.
Ultrasound gel mislabeled with inappropriate use.
Advance Medical Designs is recalling procedural kits containing ultrasonic transmission gel with specific model numbers because the gel is mislabeled. This mislabeling could lead to improper use of the gel during medical procedures, potentially causing harm.
The ultrasonic transmission gel is mislabeled with inappropriate use instructions. This could lead to incorrect application during medical procedures, potentially causing ineffective treatments or unintended harm to patients.
Medical professionals using these procedural kits for ultrasound procedures are most at risk. Patients receiving treatments with the mislabeled gel may also be affected.
Check for model numbers 28-EG103, 28-EG125, 28-EG135, 28-EG151, 28-EG161, 28-EG163, or 28-EG197 on the gel packaging. Also look for the specific lot numbers listed in the recall notice.
Look for model numbers 28-EG103 through 28-EG197 and associated lot numbers on the gel packaging.
The ultrasonic transmission gel is mislabeled with inappropriate use instructions, which could lead to incorrect application during medical procedures.
The mislabeling could affect ultrasound procedures where the gel is used, potentially leading to ineffective treatments or unintended harm.
Check the model numbers 28-EG103 through 28-EG197 and associated lot numbers listed in the recall notice.
We’ve drafted a message you can send Advance Medical Designs to request your refund or repair — edit it as you like.
Subject: Recall Z-2536-2023 — Advance Medical Designs Advance Medical Designs Hello, I own a Advance Medical Designs that is covered by recall Z-2536-2023 from Advance Medical Designs. 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.