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 certain lots...
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), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs. The STERRAD CYCLESURE 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
Quantity: 38,693 units
Why Was This Recalled?
Advanced Sterilization Products (ASP) is recalling certain lots of the STERRAD CYCLESURE 24 Biological Indicator (BI) product because it does not have adequate data to support the entire duration of the product's labeled shelf-life.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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