Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
STERRAD Cyclesure Biological Indicator (BI Recalled by Advanced Sterilization Products Due to Advanced Sterilization Products (ASP) is recalling the STERRAD...
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 Advanced Sterilization Products directly.
Affected Products
STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
Quantity: 4048 units total (4014 units in US)
Why Was This Recalled?
Advanced Sterilization Products (ASP) is recalling the STERRAD Cyclesure Biological Indicator (BI) because ASP has identified a microscopic intermittent and low frequency flaw in the outer vial of the STERRAD Cyclesure 24 Biological Indicator.
Where Was This Sold?
Worldwide Distribution.
About Advanced Sterilization Products
Advanced Sterilization Products has 36 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report