Medline recalls specific probe cover kits for ultrasound procedures due to potential inadequate seam barriers. These kits may allow sterile ultrasound gel to leak during procedures. Affected kits include models from NORTON CHILDRENS CATH LAB-LF to ZZZZ DYNJ53433J, distributed between December 2017 and May 2023.
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Medline is recalling probe cover kits used with ultrasound devices because the covers may have weak seams that let sterile ultrasound gel leak. This could lead to contamination during medical procedures. The affected kits have specific model numbers and were sold between December 2017 and May 2023.
The probe covers may have inadequate barriers at the seams, allowing sterile ultrasound gel to leak during procedures. This could lead to contamination of the procedure site or equipment, potentially increasing infection risk for patients and staff.
Healthcare professionals using these kits during ultrasound procedures are most at risk. Patients receiving procedures with these kits could be exposed to potential contamination.
Check for model numbers listed in the recall: NORTON CHILDRENS CATH LAB-LF (00-401185Q) through ZZZZ DYNJ53433J. These kits were distributed by Medline between December 2017 and May 2023.
Look for model numbers on the kit packaging or label to confirm if it's affected.
If you have an affected kit, contact Medline directly for a replacement or refund.
No, these kits have a risk of leaking sterile ultrasound gel due to inadequate seam barriers, so they should not be used.
Check the model number on the kit. Affected kits include those labeled from NORTON CHILDRENS CATH LAB-LF (00-401185Q) to ZZZZ DYNJ53433J, distributed between December 2017 and May 2023.
Contact Medline directly for a replacement or refund of the affected kit.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2163-2023 — Medline Medline Hello, I own a Medline that is covered by recall Z-2163-2023 from Medline. 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.