CLASS II Device recall · Reported 17 Jun 2015 · FDA Enforcement Report
AccuChek Spirit Combo insulin infusion pump sold as part recalled
Roche Diabetes Care is recalling AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System, distributed nationwide in the US. The recall was initiated on 22 Apr 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1733-2015
- FDA event ID
- 71235
- Recalling firm
- Roche Diabetes Care, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Apr 2015
- FDA classified
- 9 Jun 2015
- Reported
- 17 Jun 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Infusion Pumps
Timeline
| 22 Apr 2015 | Recall initiated by company | |
| 9 Jun 2015 | Classified by FDA | +48 days |
| 17 Jun 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.
Where it was distributed
Nationwide Distribution
Questions about this recall
Why was it recalled?
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
Which lots are affected?
All Serial Numbers Models: 1. 05458544001, Accu-Chek Combo Kit mg US/English version. 2. 05504686001, Accu-Chek Combo Kit mg US/Spanish version. 3. 05391512001, Accu-Chek Spirit Combo Replacement Pump US/EN. 4. 05391750001, Accu-Chek Spirit Combo Demo Pump US. 5. 04759702001, Accu-Chek Spirit Pump Kit US/CA Back Up. 6. 04540492001, Accu-Chek Spirit Pump Kit US/CA. 7. 04759729001, Accu-Chek Spirit Replacement Pump.
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 71235| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | AccuChek Spirit insulin infusion pump recalled by Roche Diabetes Care | Roche Diabetes Care | Device Malfunction | Nationwide |
More recalls from Roche Diabetes Care
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Accu-Chek Guide (SC) Kit -Intended to quantitatively recalled | Roche Diabetes Care | Other | Nationwide |
| Device | CLASS II | RocheDiabetes Care Platform recalled | Roche Diabetes Care | Device Malfunction | Nationwide |
| Device | CLASS II | Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System recalled | Roche Diabetes Care | Labeling Errors | Nationwide |
| Device | CLASS II | Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System recalled | Roche Diabetes Care | Labeling Errors | Nationwide |
| Device | CLASS II | Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System recalled | Roche Diabetes Care | Labeling Errors | Nationwide |
Other Infusion Pumps recalls
All 546| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS I | Baxter Duo-Vent Solution Set and Male Luer Lock Adapter recalled | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical | ICU Medical | Other | Nationwide |
| Device | CLASS II | Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled | Boston Scientific | Packaging Defects | Nationwide |