Direct Water feed Kit — Class II medical device recall Z-1661-2015
Terminated recall by Siemens Medical Solutions Diagnostics, reported 2015-06-03. The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening
| Recall number | Z-1661-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions Diagnostics, Flanders, NJ, United States |
| Recall initiated | 2015-03-05 |
| Classified | 2015-05-23 |
| Reported by FDA | 2015-06-03 |
| Terminated | 2018-01-16 |
| Quantity | 15 bottles |
| Model numbers | 10373222 |
Product
Direct Water feed Kit, Catalog#10373222
Reason for recall
The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.
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-1661-2015. 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.