AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek… — Class II medical device recall Z-1733-2015
Terminated recall by Roche Diabetes Care, Inc., reported 2015-06-17, distributed nationwide. Roche has become aware of an increase of mechanical errors experienced by customers using the Accu-Chek Spirit
| Recall number | Z-1733-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diabetes Care, Inc., Indianapolis, IN, United States |
| Recall initiated | 2015-04-22 |
| Classified | 2015-06-09 |
| Reported by FDA | 2015-06-17 |
| Terminated | 2016-11-03 |
| Distributed | Nationwide (US) |
| Quantity | 35,795 |
| Model numbers | 05458544001 |
Product
AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.
Reason for recall
Roche has become aware of an increase of mechanical errors experienced by customers using the Accu-Chek Spirit Combo insulin infusion pump and Accu-Chek Spirit insulin infusion pump when the insulin pumps display E6 and El0 error messages. If the user does not act upon the E6 and E10 error messages appropriately, insulin delivery will be stopped and if unnoticed may lead to severe hyperglycemia u
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-1733-2015. 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.