Medline recalls breast and plastic probe cover kits with sterile ultrasound gel due to potential inadequate seam barriers during diagnostic procedures. Affected kits sold between Dec 2017-May 2023.
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Medline is recalling several probe cover kits for ultrasound procedures because they may have weak seams that could allow ultrasound gel to leak. This could lead to contamination or infection during medical procedures if the covers are used improperly.
The probe covers may have inadequate barriers at the seams, potentially allowing sterile ultrasound gel to leak during procedures. This could lead to contamination or infection if the gel comes into contact with the patient or environment.
Healthcare professionals using these kits for diagnostic ultrasound procedures are most at risk. Patients receiving these procedures may also be affected if the covers become contaminated.
Check for model numbers listed in the recall: DYNDH1306, DYNDH1389B, DYNJ35262A, DYNJ39508A, DYNJ55954C, DYNJ63893, DYNJ63893A, DYNJ67367, DYNJ67381, DYNJ68321B, DYNJ82250, DYNJ84305, DYNJ904598B, DYNJ905002B, DYNJ905004B, DYNJ905004C, DYNJ908890, DYNJ908890A, DYNJ908892, DYNJ908892A. Kits were sold between December 2017 and May 2023.
Look for the model number on the kit label to confirm if it's affected by this recall.
Reach out to Medline directly for assistance with replacement or return options.
The recall states that the probe covers may have inadequate barriers at the seams, which could lead to leakage of sterile ultrasound gel. Users should check if their kit is affected before use.
Check the model number on your kit label. Affected models include DYNDH1306, DYNDH1389B, DYNJ35262A, and others listed in the recall notice. Kits were sold between December 2017 and May 2023.
Contact Medline directly for replacement or return options. The recall does not specify a deadline for action.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2177-2023 — Medline Medline Hello, I own a Medline that is covered by recall Z-2177-2023 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.