STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324
Medical device recall Z-0520-2013. Published in FDA’s Enforcement Report on Dec 19, 2012.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 19, 2012. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 38,532 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
38,532 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot: 225117 337117 295117 334117 227117 338117 296117 326117 227118 264117 300117 327117 230117 265117 301117 330117 233117 266117 302117 331117 235117 267117 310117 331118 235118 268117 311117 332117 237117 269117 312117 335117 239117…
Every code shown here, 2,000 characters
Lot: 225117 337117 295117 334117 227117 338117 296117 326117 227118 264117 300117 327117 230117 265117 301117 330117 233117 266117 302117 331117 235117 267117 310117 331118 235118 268117 311117 332117 237117 269117 312117 335117 239117 270117 313117 341111 241117 273117 314117 343111 242117 275117 315117 348111 243117 277117 316117 350111 244117 278117 317117 245117 280117 318117 246117 281117 319117 249117 282117 321111 253117 283117 321117 255117 284117 322111 257117 285117 322117 259117 287117 323111 261117 289117 323117 263117 291117 324117 333117 292117 325111 334111 294117 325117 336111 357111 333111 04581Z 07781Z 10081Z 14881Z 04681Z 07482Z 10082Z 14981Z 04781Z 07981Z 10381Z 15081Z 04981Z 07881Z 10981Z 15281Z 05081Z 07581Z 10881A 15681Z 05281Z 08181Z 10581Z 15781Z 05181Z 07381Z 10681A 15881Z 05681Z 08481Z 10181Z 15981A 05781Z 08081Z 10281Z 15481Z 05981Z 08281Z 10282A 16381Z 05782Z 08482Z 11281Z 16481Z 06081Z 08581Z 10882Z 16881Z 06181Z 08582Z 11381Z 16181A 06182Z 08681Z 11081A 16581Z 05381Z 08682Z 11082Z 16981Z 05881Z 08781Z 11481Z 17081Z 05982Z 08881A 11681Z 17281A 06381Z 08981Z 12081Z 17581Z 06481Z 07782Z 12181Z 17781A 06482Z 09181Z 12381Z 17981A 06581Z 09281Z 12881Z 17681Z 06681Z 09282Z 13081Z 18281A 06682Z 08782A 13381Z 18581Z 06882Z 09481Z 13581Z 18981Z 06781Z 09381Z 12781Z 19081Z 06881Z 09482Z 13681Z 19181A 07081Z 09581Z 13881Z 19381A 07181Z 09881Z 14081Z 18381Z 07182Z 09981Z 14281Z 19681Z 07481Z 09982Z 14381Z 19781A 19881Z 26081Z 31581Z 02891Z 19981A 26381Z 31681Z 03091Z 20381A 26781Z 31881Z 03491Z 20481A 26881Z 31981Z 03591A 20581A 27081Z 32281Z 03791Z 21381Z 27381Z 32381Z 04091Z 21481A 27481Z 32581Z 04191Z 21881A 27581Z 32981Z 04391Z 21081A 27781Z 33081Z 04491Z 21281A 28181Z 33681Z 04991Z 22081A 28281Z 33781Z 05091Z 20681A 28381Z 33981Z 05191A 22181Z 28481Z 34081Z 05591Z 22481Z 28781A 34381Z 05691Z 22581A 28981Z 35081Z 05891Z 22781Z 29081Z 35181Z 06191Z 22881A 29181Z 35381Z 06291Z 23181A 29481Z 35481Z 06491Z 23381Z 29581Z 35581Z 06891Z 23481Z 29681Z…
FDA’s list runs to 5,723 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution-USA (nationwide) and the countries of AR, AU, BE, BR, CA, CL, CN, CO, EC, GT, HK, ID, IN, JP, KR, MX, MY, PA, PE, PH, SG, TH, VE, and RU.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 3, 2012.
- FDA classified it on Dec 12, 2012.
- FDA’s Enforcement Report published it on Dec 19, 2012.
- FDA terminated it on Jul 19, 2013.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Advanced Sterilization Products, of Irvine, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 5,723 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.