FDA Device recall Z-1997-2025
Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-…
- FDA Device
- Class II
- ongoing
- Published 2025-07-02
On 2025-07-02 the FDA classified a Class II recall of Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-… by Bigfoot Biomedical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1997-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-21 |
| Published | 2025-07-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Bigfoot Biomedical |
| Distribution | US |
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.
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 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.
Identifiers
| code_info | Product Description / Item Number / UDI-DI code / Serial Number: Humalog/lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171…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 KR2 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1997-2025%22
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