Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

STERRAD CYCLESURE 24 Biological Indicator (BI) product Recalled by Advanced Sterilization Products Due to Advanced Sterilization Products (ASP) is recalling all lots...

Date: October 3, 2012
Company: Advanced Sterilization Products
Status: Terminated
Source: FDA (Device)

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 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI products: Codes/Serial Numbers, Product Description: 14324 Sterrad Cyclesure 24 Biological Indicator. 14324-02 Sterrad Cyclesure 24 Biological Indicator. 10134 Sterrad 100NX Express Cycle Kit. 10135 Sterrad 100NX Express Cycle Upgrade Kit. 10137 Sterrad 100NX Duo Cycle Upgrade kit. 14325 Cyclesure Challenge Pack Kit. 20103 Sterrad 100NX Test Pack Kit. 20228 Sterrad 100NX Intl Validation Kit. 20229 Sterrad 100NX Validation Kit, USA. 20232 Sterrad 50/100S Validation Kit. 20236 Sterrad 50/100S Validation Kit. 20248 Sterrad 100NX Express Validation Kit. 20253 Sterrad NX Validation Kit. 20254 Sterrad NX Validation Kit Domestic, US. 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: 38,532 units

Why Was This Recalled?

Advanced Sterilization Products (ASP) is recalling all lots of Sterrad Cyclesure 24 Biological Indicator (BI) manufactured between February 2008 and December 2011 because it may not have adequate data to support the entire duration of the labeled shelf-life.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Advanced Sterilization Products

Advanced Sterilization Products has 36 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report