# FDA recall Z-1997-2025

> **BIGFOOT BIOMEDICAL** · Class II · device recall initiated 2025-05-21.

## 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 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.

## Key facts

- **Recall number:** Z-1997-2025
- **Recalling firm:** BIGFOOT BIOMEDICAL
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-21
- **Report date:** 2025-07-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Milpitas, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1997-2025

## Citation

> AI Analytics. FDA recall Z-1997-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1997-2025. Source: US FDA. Licensed CC0.

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