Cook Incorporated 2025-05-28 Health serious FDA
Health · FDA · Recall #FDA-Z-1786-2025
Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF… Recall
Issued May 28, 2025 · Cook Incorporated
In May 2025, Cook Incorporated recalled the Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
What you should do
- 1 Stop using Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Cook Incorporated to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Cook Incorporated
- Category
- Health
- Recall date
- May 28, 2025
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of Belgium, Germany, Spain, France, Ireland, Italy Netherlands, Switzerland, South
- Recall number
- FDA-Z-1786-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Cook Incorporated has 12 recalls in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.