Recall Z-1997-2025 ยท QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
BIGFOOT BIOMEDICAL
Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot Inject v1 Pen Cap RCAP Firmware 1.3.0 Release Configuration, Rev H The Bigfoot Unity Diabetes Management System that include the Pen Caps (Rapid-Acting Insulin Pen Cap [RCAP] and Long-Acting Insulin Pen Cap [LCAP]) integrates continuous monitoring w
| Date | Jun 20, 2025 (initiated May 21, 2025) |
| Status | Open, Classified |
| Reason | Due to a software/firmware issue diabetes management system may provide a device error and cause the insulin pen to become unresponsive and unable to function. This error may pose a potential health risk for people living with diabetes as they may not have all information necessary to make a timely treatment decision. |
| Root cause | Software design |
| Action | On 05/21/2025, the firm sent via FedEx and USPS Priority Mail, "URGENT MEDICAL DEVICE RECALL" Letters to Customers and Prescribers informing them that the Bigfoot Unity Pen Caps, both Long-Acting and Rapid-Acting Pen Cap firmware version 1.3.0 may provide a screen with "Device Error - Contact Bigfoot Customer Care" and render the pen caps unresponsive and unable to function. Customer are instructed to: 1. If customers have the affected product identified above, we are asking you to return the product. We have sent you a return kit, which you should receive shortly. If the return kit does not |
| Quantity | 57 pen caps |
| Distribution | U.S. Nationwide distribution in the states of AL, FL, GA, IA, IL, NY, PA, TX, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202145 | Bigfoot Unity Diabetes Management System Bigfoot Biomedical, Inc., May 7, 2021 |