Advanced Sterilization Products Sterrad CycleSure Biological Indicator, Product Code 14324. The Sterrad CycleSure Biological Indicator is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilizer cycles. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Sterrad CycleSure Biological Indicator, Product Code 14324. The Sterrad CycleSure Biological Indicator is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilizer cycles.
Brand
Advanced Sterilization Products
Lot Codes / Batch Numbers
All Lots.
Products Sold
All Lots.
Advanced Sterilization Products is recalling Sterrad CycleSure Biological Indicator, Product Code 14324. The Sterrad CycleSure Biological Indica due to Biological Indicator indicating a positive result does not maintain yellow color for the entire incubation period and some indicators experience media. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Biological Indicator indicating a positive result does not maintain yellow color for the entire incubation period and some indicators experience media evaporation prior to the end of the labeled maximum incubation time.
Recommended Action
Per FDA guidance
An Important Product Labeling Correction - New Instructions for Use dated, June 26, 2009, has been proposed to be sent by the firm for Cyclosure Biological Indicators to consignees. The revised instructions reduce the maximum read time for the indicators to 3 days (72 hours). The letter also states why ASP changed the Instructions. Questions are to be directed to ASP Customer Care Center.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026