STERRAD 100S
Medical device recall Z-0843-2015. 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 100S, Product Code 10113. 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
10101038398 10102984490 10101061085 10101006013 10101962406 10101016311 10101026708 101083328 10101016316 10101061144 10101016449 10101083087 10101006100 10101048602 101104680 10101016420 10101083507 10101973506 10101962610 101094102…
Every code shown here, 1,996 characters
10101038398 10102984490 10101061085 10101006013 10101962406 10101016311 10101026708 101083328 10101016316 10101061144 10101016449 10101083087 10101006100 10101048602 101104680 10101016420 10101083507 10101973506 10101962610 101094102 10101073735 10101973491 10101962462 10101038169 10101048613 10101059369 10101061101 10101995598 10101006162 10101984454 10101984119 10101038147 10101026626 10101061509 10101073741 10101962546 10101962882 10101073729 10101026724 10101005913 10101038256 10101984290 10101059615 10101995219 10101059538 10101930412 10101061045 10101984170 101110322 10101016409 10101048663 10101963281 101110554 10101006065 10101038254 10101016279 101083249 10101962822 10101031012 10101984146 10101962593 10101073226 10101048648 10101048860 10101016503 10101006062 10101073256 10101048777 10101973618 101105300 101110522 10101006011 10101995293 10101038387 10101963216 10101963379 10101026711 10101962718 10101083052 10101952071 10101059212 10101962873 10101006004 10101962708 10101026777 10101006083 101083229 10102984544 10101061310 10101995063 10101984140 10101973409 10101962400 101130068 101094167 10101995139 10101963271 10101963275 10101073361 10101016515 10101973635 10101962551 10101963217 101083271 10101006012 10101962823 10101048901 10101962441 10101061325 10101059257 10101073676 10101048608 10101006114 101120244 10101038255 10101026979 101083525 101094401 10101973576 10101995163 10101073505 10101005879 10101962887 10101016393 10101984458 10101016235 10101984331 10101962443 10101984038 10101026617 10101059428 10101952047 10101962390 10101048600 10101995242 10101048594 10101026924 10101073481 10101061264 10101059599 10101962209 10101952092 10101952091 10101073289 10101026683 10101995371 10101016212 10101952053 10101083112 10101059357 10101973435 10101984090 10101962756 10101995517 10101059344 10101952063 10101061459 10101073110 10101026727 10101073023 101110419 10101995285 10101038420 10101026961 10101026964 10101048671 10101038150 10101073233 10101962625…
FDA’s list runs to 9,613 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 9,613 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.