CLASS II Device recall · Reported 8 Jan 2014 · FDA Enforcement Report

Sterrad Cyclesure Biological Indicator (BI recalled

Advanced Sterilization Products is recalling Sterrad Cyclesure Biological Indicator (BI. The recall was initiated on 26 Nov 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatch/Lot No. 14913706 15013706 15413706 15413106 15513706 15613706 15713706 15913706 16113706 16113106 16213706 16413706 16413806 16613706 16813706 16813806 16913706 17113706 17213706 17513706 17613706 17713706 17813706 17913706 18013706 18313706 18413706 18913706 19013706 19113706 19213706 19313706 19613706 19713706 19813706 19913706 20013706 20113706 20313706 20413706 20613706 20713706 20813706 21113706 21213706 21313706 21413706 21513706 21513806 21713706 21813706 21913706 22013706 22113706 22213706 22413706 22513706 22613706 22713706 22813706 22913706 23113706 23113806 23213706 23313706 23413706 23513706 23813706 23913706 24013706 24113706 24513706 24813106 24913706 25313106 25613106 26113106 26613106 26813106 27313106 27513106 28713106 28913106 29513106 30113106

Quantity recalled4048 units total (4014 units in US)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0604-2014
FDA event ID: 66981
Recalling firm: Advanced Sterilization Products, Irvine, CA
Classification: Class II
Status: Terminated
Recall initiated: 26 Nov 2013
FDA classified: 28 Dec 2013
Reported: 8 Jan 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Patient Monitors

Timeline

26 Nov 2013	Recall initiated by company
28 Dec 2013	Classified by FDA	+32 days
8 Jan 2014	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution.

Questions about this recall

Why was it recalled?

Which lots are affected?

Batch/Lot No. 14913706 15013706 15413706 15413106 15513706 15613706 15713706 15913706 16113706 16113106 16213706 16413706 16413806 16613706 16813706 16813806 16913706 17113706 17213706 17513706 17613706 17713706 17813706 17913706 18013706 18313706 18413706 18913706 19013706 19113706 19213706 19313706 19613706 19713706 19813706 19913706 20013706 20113706 20313706 20413706 20613706 20713706 20813706 21113706 21213706 21313706 21413706 21513706 21513806 21713706 21813706 21913706 22013706 22113706 22213706 22413706 22513706 22613706 22713706 22813706 22913706 23113706 23113806 23213706 23313706 23413706 23513706 23813706 23913706 24013706 24113706 24513706 24813106 24913706 25313106 25613106 26113106 26613106 26813106 27313106 27513106 28713106 28913106 29513106 30113106

Where was it sold?

Worldwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Advanced Sterilization Products

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22 Feb 2017Device	CLASS II	Sterrad NX Sterilization System, Product recalled	Advanced Sterilization Products	Sterility	Nationwide
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23 Sep 2015Device	CLASS II	Cidex OPA Solution recalled by Advanced Sterilization	Advanced Sterilization Products	Sterility	CA
2 Sep 2015Device	CLASS II	Cidex Activated Dialdehyde Solution/case recalled	Advanced Sterilization Products	Sterility	Nationwide
19 Aug 2015Device	CLASS II	Wall Chart for Sterrad 100NX System recalled by Advanced Sterilization	Advanced Sterilization Products	Sterility	Nationwide

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