Class II FDA device recall · Z-1997-2025

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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 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.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / 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

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

U.S. Nationwide distribution in the states of AL, FL, GA, IA, IL, NY, PA, TX, and WA.

Recall record

Recalling firm: BIGFOOT BIOMEDICAL
Product type: Devices
Recall number: Z-1997-2025
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Milpitas, CA
Recall initiated: 2025-05-21

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-1997-2025 · Source: openFDA enforcement.