Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Stay Safe Cap Recalled by Fresenius Medical Care Holdings, Inc. Due to Updating the labeling to include additional warnings and...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Fresenius Medical Care Holdings, Inc. directly.
Affected Products
Stay Safe Cap
Quantity: 18,236,160 eaches
Why Was This Recalled?
Updating the labeling to include additional warnings and contraindications for potential side effects.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fresenius Medical Care Holdings, Inc.
Fresenius Medical Care Holdings, Inc. has 161 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report