Wall Chart for STERRAD 100NX System, P/N 10104
Medical device recall Z-2375-2015. Published in FDA’s Enforcement Report on Aug 19, 2015.
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 Aug 19, 2015. 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
- 1465 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 the Wall Chart for STERRAD 100NX System because it incorrectly states “APTIMAX Instrument Trays can be enclosed in either polypropylene wrap or in Tyvek Pouches with STERRAD Chemical Indicators.”
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures.
1465 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
1041110428 1041110429 1043141347 1043130246 1041100160 1041100193 1043140260 1041110040 1041120389 1041110125 1043150133 1041090452 1041120062 1041130103 1041070049 1041100128 1043141230 1041100228 1041110512 1041080260 1041100245…
Every code shown here, 1,994 characters
1041110428 1041110429 1043141347 1043130246 1041100160 1041100193 1043140260 1041110040 1041120389 1041110125 1043150133 1041090452 1041120062 1041130103 1041070049 1041100128 1043141230 1041100228 1041110512 1041080260 1041100245 1041100325 1041100327 1041100328 1041110513 1043141014 1041080059 1041120039 1043141234 1041110214 1041120483 1041110516 1041120099 1043140161 1043140298 1041100218 1041080204 1043150029 1041120098 1041120108 1041120334 1043141214 1043141222 1041090297 1041120050 1041120051 1043140068 1041090307 1041100235 1041110411 1043141042 1041100219 1041090328 1041110137 1041130401 1041090293 1043150141 10104001070042 10104001070043 1041120390 10104001080074 1041130188 1041130009 1041080082 10104001080031 1041130067 1041130070 10104001080092 1041080188 1041110119 1041120488 1043140137 1041130229 1041090298 1041120061 1041120075 1041120077 1041100288 1041100292 1041080226 1041090350 1041110105 1041110559 1041080078 1041090352 1041120503 1041080185 1041110294 1041120068 1041120025 1041110493 1041120152 1043140124 1041090271 1041080182 1041090303 1041120057 1041120060 1043140054 1041110473 1041090339 1041110057 1041110407 1041120049 1041110515 1041120065 1041120265 1041090280 1041110237 1041090458 1041130155 1041100253 10104001080087 1043140131 1041100060 1043150155 1043150142 1041080179 1041120203 1041110405 1041110443 1043140185 10104001070039 1041090475 1041120139 1041110124 1041110481 10104001070044 1041120476 1041130037 1041090277 1041130150 1043150194 1043150204 1043150196 1041110562 1041120490 1041110431 1041120018 1041110247 1043140085 1043150183 1041120028 1041100047 1041100045 1041080077 1041130440 1041130446 1041130051 1041100243 1041110509 1041100115 1041100294 1041120067 1041100208 1041100213 1041110491 1042080055 1041080061 1041110465 1041110265 1043150172 1043140070 1041100299 1041130129 1041130123 1041090484 1041080174 1041120266 1041100139 10104001080069 1043130262 1041100008 1041100184 1041130175 1043150147 1043150157 1041110520…
FDA’s list runs to 16,520 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.
Nationwide Distribution.
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.
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 Jul 17, 2015.
- FDA classified it on Aug 13, 2015.
- FDA’s Enforcement Report published it on Aug 19, 2015.
- FDA terminated it on May 20, 2016.
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 16,520 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.