FDA Medical devices recall ·
Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1… recall
- Recall number
- Z-1997-2025
- Date
- (initiated May 21, 2025)
- Company / brand
- Bigfoot Biomedical
1820 Mccarthy Blvd, Milpitas, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 57 pen caps
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
U.S. Nationwide distribution in the states of AL, FL, GA, IA, IL, NY, PA, TX, and WA.
States: Alabama Florida Georgia Iowa Illinois New York Pennsylvania Texas Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1997-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.