STERRAD 100NX
Medical device recall Z-0846-2015. 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 100NX, Product Code 10144 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
1041070006 1041110463 1041130010 1041120317 1041110288 1043140062 1041100046 1041110354 1041120503 1041110470 1041110535 1043140130 1041080063 1041100017 1041090452 1041120495 1041130225 1041090339 1041120488 1043140028 1041140082…
Every code shown here, 1,991 characters
1041070006 1041110463 1041130010 1041120317 1041110288 1043140062 1041100046 1041110354 1041120503 1041110470 1041110535 1043140130 1041080063 1041100017 1041090452 1041120495 1041130225 1041090339 1041120488 1043140028 1041140082 1041120266 1041080194 1043141011 1043140268 1041100179 1041100065 1041110108 1041130141 1041090462 1041110033 1041110428 1041090416 1041130179 1041130391 1041130323 1043141016 1041080098 1041130195 1041110150 1041090392 1041120216 1041120041 1041110089 1041120056 1041130103 1041120215 1041120357 1041110449 1043140031 1041120463 1041100129 1043130282 1041110265 1041100081 1043140313 1041120233 1043140308 1043140131 1041110015 1041100191 1041110045 1041120275 1041130074 1041110301 1041090409 1041110028 1041110030 1041110435 1041110564 1041120386 1041120040 1041120091 1041100007 1041100015 1041090477 1041130058 1041130072 1041110569 1041100215 1041110035 1.0104E+13 1043130134 1041130121 1041090312 1041120162 1041110557 1041110179 1041090488 1041110522 1041070025 1041090413 1.0104E+13 1041120272 1041080227 1043140261 1041100219 1041100261 1041130318 1.0104E+13 1041100126 1041110167 1041130129 1041110497 1041120231 1041100026 1041100024 1041100291 1043140188 1041130197 1041080196 1041090456 1043140184 1041080205 1041130343 1041130186 1041100057 1043140084 1043140094 1041120068 1041090408 1043130270 1041090296 1041120003 1041100324 1041090384 1041130150 1.0104E+13 1041130151 1041070018 1041120238 1043140082 1041120484 1041080259 1041110193 1041110213 1041130175 1041100299 1043141018 1041070005 1043130266 1041110473 1041110057 1043130187 1.0104E+13 1.0104E+13 1.0104E+13 1041110493 1041100085 1041130111 1041110552 1041110133 1043140284 1041120482 1041110067 1041120133 1041080069 1041090271 1041120512 1041120496 1043140302 1043130280 1041120172 1041120112 1041120082 1041110486 1041120390 1041130026 1041080100 1041070017 1041100119 1.0104E+13 1041110144 1041120236 1.0104E+13 1041130061 1041120469 1041110165 1041130184 1041110077 1041130221…
FDA’s list runs to 6,863 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 6,863 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.