Reported Jul 2, 2025 · Ongoing
Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release…
Bigfoot Biomedical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BIGFOOT BIOMEDICAL · 1820 Mccarthy Blvd · Milpitas, CA · 95035-7425
Is this the product you have?
- 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.
- Lot codes and dates
57 of 57 products
Products covered by this recall Model / number Barcodes Product as published FG-30017100850003506418KR242250013 Lantus-Glargine Bigfoot Unity OMS Cap FG-30017600850003506463SL240720021 Novolog/Aspart Bigfoot Unity OMS Cap FG-30017400850003506449FR242280004 Novolog/Aspart Bigfoot Unity OMS Cap FG-30017400850003506449FR242280005 Fiasp Bigfoot Unity DMS Cap FG-30017300850003506432TR240950015 Lantus-Glargine Bigfoot Unity OMS Cap FG-30017600850003506463SL240720022 Levmr FlxT/Tresiba-Degl Bigfoot Unity OMS Cap FG-30017900850003506494TL242340007 Levmr FlxT/Tresiba-Degl Bigfoot Unity OMS Cap FG-30017900850003506494TL242340008 Humalog/lispro/Lyumjev Bigfoot Unity OMS Cap FG-30017100850003506418KR242250014 Novolog/Aspart Bigfoot Unity OMS Cap FG-30017400850003506449FR242280006 Levmr FlxT/Tresiba-Degl Bigfoot Unity OMS Cap FG-30017900850003506494TL242340010 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-30017100850003506418KR242250015 Lantus-Glargine Bigfoot Unity OMS Cap FG-30017600850003506463SL240720023 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-30017100850003506418KR242250016 Novolog/Aspart Bigfoot Unity OMS Cap FG-30017400850003506449FR242280007 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-30017100850003506418KR242250017 Basaglar Bigfoot Unity OMS Cap FG-30017500850003506456FR242280009 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-30017100850003506418KR242250018 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-30017100850003506418KR242250020 Levmr FlxT/Tresiba-Degl Bigfoot Unity OMS Cap FG-30017900850003506494TL242340009 Novolog/Aspart Bigfoot Unity OMS Cap - Amount recalled
- 57 pen caps
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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