STERITITE Containers: STERITITE Container Kit, 1/4 size, 3” high
Medical device recall Z-0434-2014. Published in FDA’s Enforcement Report on Dec 11, 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 Dec 11, 2013. Copied from openFDA on Oct 20, 2026.
- Class III FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 267 units total (252 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 III, the least serious of FDA’s three classes.
“Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.”
openFDA, in plain words, its enforcement report fields.
“Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”
FDA’s rule, 21 CFR 7.3(m)(3), 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 SteriTite containers because they do not have consistent data to show that sterility assurance level of 10(-6) is achieved during the half-cycle test runs on new, unprocessed containers.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
STERITITE Containers: STERITITE Container Kit, 1/4 size, 3” high, product code: 13902; STERITITE Mini Mid Size, 3” high, product code: 13903; STERITITE Container Kit, 1/2 size, 4” high, product code: 13904; STERITITE Container Kit, 3/4 size, 4” high, product code: 13905; STERITITE Container Kit, Full size, 4” high, product code: 13906. The ASP STERITITE sealed container system provides an efficient and cost-effective way to package and protect surgical instruments for sterilization, transportation, storage, and aseptic presentation of contents.
267 units total (252 units in US), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Batch numbers: Batch 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1071641 1071641 1030704 1030704 1071641…
Every code shown here, 1,995 characters
Batch numbers: Batch 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1071641 1071641 1030704 1030704 1071641 1030704 1071641 1071641 1071641 1071641 1030704 1030704 1071641 1071641 1071641 1079723 1079723 1079723 1079723 1079723 1079962 1079962 1079962 1079962 1079962 1079962 1079962 1079962 1079962 1079962 1079962 1079962 1081092 1081092 1081092 1081092 1081092 1081092 1081092 1081092 1081092 1081092 1081092 1071641 1081088 1081092 1081088 1081088 1081088 1081088 1081088 1081088 1081088 1081088 1081088 1081088 1081088 1082503 1081090 1081090 1081090 1081090 1082501 1082501 1082503 1082503 1082503 1082503 1082503 1082503 1082503 1082501 1082501 1082501 1082501 1082501 1082503 1082503 1082503 1081092 1082503 1081092 1081092 1081092 1081092 1081092 1081092 1081092 1085115 1081092 1081092 1081092 1086020 1086020 1086020 1086020 1086424 1086424 1081090 1086423 1087992 1086423 1082501 1081088 1085115 1085115 1086020 1081090 1087992 1086423 Batch 1030705 1030705 1030705 1030705 1030705 1030705 1030705 1071642 1071642 1071642 1071642 1071642 1071642 1071642 1071642 1071642 1030705 1030705 1030705 1030705 1030705 1030705 1078551 1078551 1078551 1078551 1078551 1078551 1078551 1078551 1078551 1079627 1079627 1079627 1079626 1079626 1079627 1079626 1079626 1079963 1079963 1079963 1080892 1079963 1080892 1080892 1080892 1080892 1080892 1080892 1080892 1080892 1080892 1080892 1079963 1080892 1079963 1079963 1079963 1079963 1079963 1079963 1079963 1079963 1080890 1079963 1080890 1080890 1080890 1080890 1081084 1081084 1081084 1080890 1080890 1081084 1081084 1080890 1080890 1080890 1081084 1081084 1081084 1081084 1081084 1081084 1081084 1082390 1081084 1082390 1082390 1081084 1082390 1084584 1084584 1084584 1085118 1085118 1085118 1082390 1082390 1082390 1082390 1085118 1082390 1082390 1082390 1081084 1082390 1081084 1085118 1086341 1081084 1081084…
FDA’s list runs to 7,996 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 Australia, Vietnam, Thailand, Malaysia, China, Korea (South), Mexico, Spain, Singapore, Hong Kong and Portugal.
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 3, 2013.
- FDA classified it on Dec 3, 2013.
- FDA’s Enforcement Report published it on Dec 11, 2013.
- FDA terminated it on Jan 13, 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 7,996 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.