STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low…
Medical device recall Z-0845-2015. Published in FDA’s Enforcement Report on Dec 31, 2014.
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 31, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 19,978 units total (9,792 units in US) 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 is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
19,978 units total (9,792 units in US), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
33090405 33101190 33120219 33100496 33110562 33130219 33110366 33130465 33111520 33130282 10033071044 33110944 33111953 33120721 33090217 33101176 10033070871 33102083 10033050639 10033060586 33102226 33111924 33101329 33100417 33101016…
Every code shown here, 1,997 characters
33090405 33101190 33120219 33100496 33110562 33130219 33110366 33130465 33111520 33130282 10033071044 33110944 33111953 33120721 33090217 33101176 10033070871 33102083 10033050639 10033060586 33102226 33111924 33101329 33100417 33101016 33111073 33120793 33110111 33090419 33100454 10033060228 10033060960 33111103 10033070692 33101139 33101386 33101053 10033070360 33120921 33120191 10033050160 10033060708 33101575 33130237 10033050205 33120742 33110536 1033141141 33110622 33090535 33090549 10033060991 33120620 33130291 10033060648 33110286 33101395 33120795 10033060743 33101375 33102015 33110760 33100411 33101406 10033060266 10033070410 10033050565 33081285 33110575 33090340 33111511 33101110 33081415 33111660 10033060407 33100166 33100318 33130097 33110043 33081367 33101197 33101343 33100592 33111108 33111413 33120560 33110415 33102140 33130353 33100423 10033060173 33081029 33110958 10033070162 10033080326 33111513 10033080222 33090107 33090352 33090118 33111583 33090560 10033060942 33111555 33110481 33101447 10033070646 33111790 33100545 33111940 33102257 33111983 33111904 33120723 33110218 10033080304 33120450 33120497 33120540 33120543 33130027 33100483 33100418 33100422 33100032 33110838 33111228 10033060274 33120838 33101567 33101002 10033070254 33111685 33050422 33110188 33110544 1033141029 1033142008 33111618 33111915 33090506 10033070765 33090385 33111025 10033060205 33111516 33110553 33111488 33110588 33130181 33101526 33090480 33130031 33101163 33130273 10033060638 33090455 33140028 33111965 33090245 10033050201 33081422 10033070645 33130458 33090005 33090567 33110340 10033070524 33140008 33111653 10033060608 33120840 33090451 33111796 10033050455 33090470 33100173 10033060658 10033070457 33100275 33110628 33111066 33110653 10033050566 33102338 33120616 33101008 10033050270 10033060591 33090016 33102332 10033060636 10033060899 33111051 33120677 33081144 10033080293 10033060506 33101042 33101142 33102166 1033141046 10033070587 33100270 33101533 33130454…
FDA’s list runs to 39,760 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.
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Nov 4, 2014.
- FDA classified it on Dec 22, 2014.
- FDA’s Enforcement Report published it on Dec 31, 2014.
- FDA terminated it on Aug 4, 2015.
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 39,760 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
-
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.