Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuratio
FDA device recall Z-1997-2025 · posted 2025-06-20 · Open, Classified
Recall details
- Recalling firm
- BIGFOOT BIOMEDICAL
- Reason for recall
- 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.
- Action taken
- 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 arrive in the next 7 days, please contact Bigfoot Biomedical Customer Care at 1-551-244-3668 or 1-888-523-3662 (toll-free number). 2. Ensure you have and continue to use a backup diabetes management plan and diabetes supplies if your Bigfoot Unity Pen Cap stops working. 3. As soon as possible, complete and return the Acknowledgement Postcard to acknowledge the understanding of the actions to be taken. o If customer's device experiences Device Error or other product issues in the future or have any questions, contact Bigfoot Biomedical Customer Care at 1-551-244-3668 or 1-888-523-3662 (tollfree number).
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- QLG
- Quantity affected
- 57 pen caps
- Distribution
- U.S. Nationwide distribution in the states of AL, FL, GA, IA, IL, NY, PA, TX, and WA.
- Date initiated
- 2025-05-21
- Date posted
- 2025-06-20
- Location
- Milpitas, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Bigfoot Unity Diabetes Management System (K202145) | Bigfoot Biomedical, Inc. | 2021-05-07 |