Class 2 Device Recall Bigfoot Unity Diabetes Management System

• Date Initiated by Firm: May 21, 2025
• Date Posted: June 20, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1997-2025
• Recall Event ID: 96925
• 510(K)Number: K202145
• Product Classification: Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems - Product Code QLG
• Product: 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 with insulin dose recommendations. The Pen Caps (Rapid-Acting Insulin Pen Cap [RCAP] and Long-Acting Insulin Pen Cap [LCAP]) are part of the Bigfoot Unity Diabetes Management System.
• Code Information: Product Description / Item Number / UDI-DI code / Serial Number: Humalog/lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250013 Lantus-Glargine Bigfoot Unity OMS Cap FG-300176 00850003506463 SL240720021 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449 FR242280004 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449 FR242280005 Fiasp Bigfoot Unity DMS Cap FG-300173 00850003506432 TR240950015 Lantus-Glargine Bigfoot Unity OMS Cap FG-300176 00850003506463 SL240720022 Levmr FlxT/Tresiba-Degl Bigfoot Unity OMS Cap FG-300179 00850003506494 TL242340007 Levmr FlxT/Tresiba-Degl Bigfoot Unity OMS Cap FG-300179 00850003506494 TL242340008 Humalog/lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250014 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449 FR242280006 Levmr FlxT/Tresiba-Degl Bigfoot Unity OMS Cap FG-300179 00850003506494 TL242340010 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250015 Lantus-Glargine Bigfoot Unity OMS Cap FG-300176 00850003506463 SL240720023 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250016 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449 FR242280007 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250017 Basaglar Bigfoot Unity OMS Cap FG-300175 00850003506456 FR242280009 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250018 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250020 Levmr FlxT/Tresiba-Degl Bigfoot Unity OMS Cap FG-300179 00850003506494 TL242340009 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449 FR242280008 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250021 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449 KL241710001 Fiasp Bigfoot Unity OMS Cap FG-300173 00850003506432 TR241570002 Bigfoot Unity Cap for Novolog ASM-10046* 00850003506173 FR242280014 Bigfoot Unity Cap for Toujeo ASM-10053* 00850003506197 ST240960003 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449 FR242280010 Levmr FlxT/Tresiba-Degl Bigfoot Unity OMS Cap FG-300179 00850003506494 TL242340011 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449 FR242280011 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449 FR242280012 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250022 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250023 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250026 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250024 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250025 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449 SL240720024 Lantus-Glargine Bigfoot Unity OMS Cap FG-300176 00850003506463 FR242280013 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449 FR242280018 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449 FR242280015 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250029 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449 FR242280016 Fiasp Bigfoot Unity DMS Cap FG-300173 00850003506432 TR241570003 Humalog/Lispro/Lyumjev Bigfoot Unity DMS Cap FG-300171 00850003506418 KR242250030 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250027 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250028 Levmr FlxT/Tresiba-Degl Bigfoot Unity OMS Cap FG-300179 00850003506494 TL242340012 Lantus-Glargine Bigfoot Unity OMS Cap FG-300176 00850003506463 SL240720026 Fiasp Bigfoot Unity DMS Cap FG-300173 00850003506432 TR241570004 Lantus-Glargine Bigfoot Unity DMS Cap FG-300176 00850003506463 SL240720027 Novolog/Aspart Bigfoot Unity DMS Cap FG-300174 00850003506449 FR242280017 Novolog/Aspart Bigfoot Unity DMS Cap FG-300174 00850003506449 FR242280019 Fiasp Bigfoot Unity DMS Cap FG-300173 00850003506432 TR241570005 Humalog/Lispro/Lyumjev Bigfoot Unity DMS Cap FG-300171 00850003506418 KR242250031 Humalog/Lispro/Lyumjev Bigfoot Unity DMS Cap FG-300171 00850003506418 KR242250032 Humalog/Lispro/Lyumjev Bigfoot Unity DMS Cap FG-300171 00850003506418 KR242250033 Humalog/Lispro/Lyumjev Bigfoot Unity DMS Cap FG-300171 00850003506418 KR242250034 Lantus-Glargine Bigfoot Unity DMS Cap FG-300176 00850003506463 SL240720028
• Recalling Firm/ Manufacturer: BIGFOOT BIOMEDICAL; 1820 Mccarthy Blvd; Milpitas CA 95035-7425
• For Additional Information Contact: Lindsy Delco; 224-280-2475
• Manufacturer 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.
• FDA Determined 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 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).
• Quantity in Commerce: 57 pen caps
• Distribution: U.S. Nationwide distribution in the states of AL, FL, GA, IA, IL, NY, PA, TX, and WA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = QLG