SYSTEM 1E Liquid Chemical Sterilant Processing System — Class II medical device recall Z-0616-2014
Terminated recall by Steris Corporation, reported 2014-01-08, distributed nationwide. Customers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of chec
| Recall number | Z-0616-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Steris Corporation, Mentor, OH, United States |
| Recall initiated | 2013-11-21 |
| Classified | 2013-12-31 |
| Reported by FDA | 2014-01-08 |
| Terminated | 2014-06-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AF, BH, GB, HK, IT, SA, TR |
| Quantity | 6,028 units |
| Reason classes | specification failure |
| Model numbers | 6500, 7500 |
Product
SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
Reason for recall
Customers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of check valve o-rings following frequent contact with S40 sterilant use solution result in nuisance aborts.
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-0616-2014. 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.