STERITITE Containers: STERITITE Container Kit — Class III medical device recall Z-0434-2014
Terminated recall by Advanced Sterilization Products, reported 2013-12-11, distributed nationwide. Advanced Sterilization Products (ASP) is recalling the SteriTite containers because they do not have consisten
| Recall number | Z-0434-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Sterilization Products, Irvine, CA, United States |
| Recall initiated | 2013-10-03 |
| Classified | 2013-12-03 |
| Reported by FDA | 2013-12-11 |
| Terminated | 2014-01-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CN, ES, HK, KR, MX, MY, PT, SG, TH, VN |
| Reason classes | sterility |
| Lot numbers | 1030704, 1030705, 1030706, 1030707, 1030708, 1070708, 1071641, 1071642, 1071643, 1071645, 1071646, 1076598, 1078551, 1078552, 1078553, 1079624, 1079626, 1079627, 1079723, 1079962, 1079963, 1080890, 1080892, 1081060, 1081062, 1081064, 1081066, 1081068, 1081070, 1081072, 1081074, 1081076, 1081078, 1081080, 1081082, 1081084, 1081088, 1081090, 1081092, 1082390 and 49 more |
Product
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0434-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.