Safety recall
Medical
FDA
Is the Custom Sterile and Non-Sterile Procedural Kits… safe?
MEDLINE INDUSTRIES, LP - Northfield · Recalled May 15, 2023
No — the Custom Sterile and Non-Sterile Procedural Kits… was recalled on May 15, 2023 due to a safety issue. Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. If you have this product: Stop using this product and follow the manufacturer's recall instructions for a refund or replacement. Contact your pediatrician if your baby was exposed and shows any symptoms.
Why it was recalled
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
What to do
Stop using this product and follow the manufacturer's recall instructions for a refund or replacement. Contact your pediatrician if your baby was exposed and shows any symptoms.
View the official FDA recall →
This is an official recall published by FDA. Recall details are current as of 2026-06-25; verify the latest status at the source.
Custom Sterile and Non-Sterile Procedural Kits…: common questions
Is the Custom Sterile and Non-Sterile Procedural Kits… safe?
No. The Custom Sterile and Non-Sterile Procedural Kits… was recalled on May 15, 2023 due to a safety issue. Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Has the Custom Sterile and Non-Sterile Procedural Kits… been recalled?
Yes. The Custom Sterile and Non-Sterile Procedural Kits… was recalled on May 15, 2023. The recall was issued by FDA (recall ID Z-2322-2023).
Why was the Custom Sterile and Non-Sterile Procedural Kits… recalled?
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
What should I do if I have the Custom Sterile and Non-Sterile Procedural Kits…?
Stop using this product and follow the manufacturer's recall instructions for a refund or replacement. Contact your pediatrician if your baby was exposed and shows any symptoms.
Where can I find the official recall notice for the Custom Sterile and Non-Sterile Procedural Kits…?
The official FDA recall record is available
here. Always verify recall details with the official source.
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