Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuratio
Summary
The FDA issued a Class II for Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap by BIGFOOT BIOMEDICAL. 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 .
Details
Source
Device Recall
External ID
Z-1997-2025
Action Date
2025-07-02
Status
Ongoing
Category
device
Product Description
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/Code Info: 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
Quantity Affected: 57 pen caps
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.
Distribution
U.S. Nationwide distribution in the states of AL, FL, GA, IA, IL, NY, PA, TX, and WA.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-21
Company
Milpitas, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 160 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (BIGFOOT BIOMEDICAL) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BIGFOOT BIOMEDICAL have FDA actions?
This is the only FDA action we have on record for BIGFOOT BIOMEDICAL in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1997-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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