Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

AccuChek Spirit insulin infusion pump. Recalled by Roche Diabetes Care, Inc. Due to Roche has become aware of an increase of...

Date: April 22, 2015
Company: Roche Diabetes Care, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Roche Diabetes Care, Inc. directly.

Affected Products

AccuChek Spirit insulin infusion pump.

Quantity: 35,795

Why Was This 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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Roche Diabetes Care, Inc.

Roche Diabetes Care, Inc. has 29 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report