AccuChek Spirit insulin infusion pump recallZ-1734-2015 · Roche Diabetes Care, Inc. · initiated Apr 22, 2015
Class II Terminated All recalls posted in June 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Roche Diabetes Care, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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
FDA root cause category: Device Design
What the company is doing
Roche sent an URGENT MEDICAL DEVICE CORRECTION notification dated April 22, 2015, to all affected customers. The letter identified the problem the product and the action needed to be taken by the customer. The recall notification included a description of the reason for the recall, customer responsibilities, training chart, and instructions for responding to the formal recall notification. Please contact the ACCU-CHEK Customer Care Service Center, 24 hours a day, seven days a week at 1-800-688-4578, if you have questions about the information contained in this notification.
Recall details
- Recall number
- Z-1734-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 22, 2015
- Posted by the FDA
- Jun 9, 2015
- Recalling firm
- Roche Diabetes Care, Inc.
- Quantity
- 35,795
- Product code
- LZG
- FDA submissions
- K042887
- Distribution
- Nationwide Distribution
Product description
AccuChek Spirit insulin infusion pump.
Code information (models, lots, serial numbers)
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.
Other devices under the same FDA submission
2 devices cleared under K042887 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Accu-Chek Spirit Cartridge 04949935001Roche Diabetes Care GmbH · Pump, Infusion, Insulin69 reports
- Accu-Chek Spirit Cartridge 05206073001Roche Diabetes Care GmbH · Pump, Infusion, Insulin30 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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