Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep Recalled by Custom Medical Specialties, Inc. Due to The firm saw on the FDA web site...
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 Custom Medical Specialties, Inc. directly.
Affected Products
CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep Product Usage: Usage: The PVP contained in the kit is used in skin prep
Quantity: 3 cases
Why Was This Recalled?
The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Custom Medical Specialties, Inc.
Custom Medical Specialties, Inc. has 21 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report