Safety recall
Medical
FDA
Is the Innova IGS 540 Indicated for use for patients from… safe?
GE Healthcare, LLC · Recalled Sep 04, 2014
No — the Innova IGS 540 Indicated for use for patients from… was recalled on Sep 04, 2014 due to a safety issue. Recalled for a safety or quality concern — see details. 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
Recalled for a safety or quality concern — see details.
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.
Innova IGS 540 Indicated for use for patients from…: common questions
Is the Innova IGS 540 Indicated for use for patients from… safe?
No. The Innova IGS 540 Indicated for use for patients from… was recalled on Sep 04, 2014 due to a safety issue. Recalled for a safety or quality concern — see details.
Has the Innova IGS 540 Indicated for use for patients from… been recalled?
Yes. The Innova IGS 540 Indicated for use for patients from… was recalled on Sep 04, 2014. The recall was issued by FDA (recall ID Z-0451-2015).
Why was the Innova IGS 540 Indicated for use for patients from… recalled?
Recalled for a safety or quality concern — see details.
What should I do if I have the Innova IGS 540 Indicated for use for patients from…?
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 Innova IGS 540 Indicated for use for patients from…?
The official FDA recall record is available
here. Always verify recall details with the official source.
Recalls get announced. TinySafe tells you.
The CPSC and FDA publish recalls — but no one tells you when a brand you use is recalled. TinySafe does. Add your baby's brands and get an alert the moment one is recalled. Launching soon on iOS.
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TinySafe is an independent app and is not affiliated with, endorsed by, or sponsored by the FDA or CPSC. Always confirm recall details with the official source. The absence of a recall does not guarantee a product is safe.
