Sterrad 100NX
Medical device recall Z-0190-2014. Published in FDA’s Enforcement Report on Nov 20, 2013.
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 Nov 20, 2013. 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
- 2106 units total (1224 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 (ASP) is recalling the Sterrad 100NX Sterilizer some healthcare workers detected odors/smells emanating from the 100NX Sterilizers, and it may be related to normal breakdown of the oil used in the Sterrad 200 vacuum pumps.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medical devices.
2106 units total (1224 units in US), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Batch 1041070019 1041080059 1041080056 1041080058 1041080055 1041080064 1041080063 1041080057 1041080060 1041070023 1041070022 1041080069 1041080070 1041080066 1041080068 1041080072 1041080073 1041080082 1041080077 1041080061 1041080074…
Every code shown here, 1,997 characters
Batch 1041070019 1041080059 1041080056 1041080058 1041080055 1041080064 1041080063 1041080057 1041080060 1041070023 1041070022 1041080069 1041080070 1041080066 1041080068 1041080072 1041080073 1041080082 1041080077 1041080061 1041080074 1041080076 1041080078 1041080079 1041080081 1041080087 1041080071 1041080093 1041080080 1041080095 1041080090 1041080089 1041080088 1041080097 1041080098 1041080091 1041080099 1041080100 1041080101 1041080096 1041080159 1041080103 1041080102 1041080104 1041080160 1041080167 1041080172 1041080168 1041080169 1041080174 1041070049 1041070051 1041070048 1041080083 1041080086 1041080165 1041080173 1041080175 1041080164 1041080163 1041080180 1041080084 1041080182 1041080184 1041080189 1041080186 1041080191 1041080178 1041080177 1041080179 1041080185 1041080193 1041080197 1041080199 1041080188 1041080195 1041080198 1041080215 1041080194 1041080214 1041080260 1041080206 1041080205 1041080212 1041080204 1041080196 1041080203 1041080259 1041080202 1041080082 1041090269 1041070047 1041080216 1041080220 1041090264 1041070155 1041090263 1041090265 1041070154 1041070156 1041090268 1041090270 1041090275 1041090276 1041090279 1041090277 1041090273 1041080219 1041080207 1041090266 1041090271 1041090343 1041090340 1041090331 1041090300 1041090333 1041090338 1041090322 1041070149 1041070025 1041070147 1041080230 1041090352 1041090350 1041080226 1041080225 1041090278 1041090272 1041090280 1041090267 1041080218 1041090287 1041090291 1041090288 1041090292 1041080221 1041090283 1041090289 1041080228 1041090284 1041080230 1041090286 1041090355 1041090354 1041090359 1041090294 1041090295 1041090293 1041090303 1041090304 1041090306 1041090309 1041090297 1041090307 1041090298 1041090360 1041090308 1041090361 1041090312 1041090296 1041090329 1041080223 1041090264 1041090309 1041090304 1041090306 1041080227 1041090318 1041090324 1041090321 1041090332 1041090336 1041090337 1041090305 1041090328 1041090339 1041090345 1041090351 1041090353 1041090347 1041090290…
FDA’s list runs to 12,082 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 EMEA, APAC, Japan, Canada. AE, AU, BE, BH, CA, CH, CL, CN, CO, DE, EC, ES, GB, GR, HK, HU, IL, IN, IT, JP, KR, KW, MX, MY, NX, PA, PH, PK, PL, PR, QA, RU, SA, SG, SI, TH, VE, VN, ZA, and Tripoli.
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 18, 2013.
- FDA classified it on Nov 8, 2013.
- FDA’s Enforcement Report published it on Nov 20, 2013.
- FDA terminated it on Jan 16, 2014.
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 12,082 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.