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RecallWatchMedical Device Safety
Class IIOngoingZ-1997-2025

BIGFOOT BIOMEDICAL recalls Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Fi…

BIGFOOT BIOMEDICALMilpitas, CA, United StatesReported Jul 2, 2025 · 1 year ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    UDI-DI code
    169 affected lots
    FG-30017100850003506418KR242250013FG-30017600850003506463SL240720021FG-30017400850003506449
    +161 more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

What the firm is doing

On 05/21/2025, the firm sent via FedEx and USPS Priority Mail, "URGENT MEDICAL DEVICE RECALL" Letters to Customers and Prescribers informing them that the Bigfoot Unity Pen Caps, both Long-Acting and Rapid-Acting Pen Cap firmware version 1.3.0 may provide a screen with "Device Error - Contact Bigfoot Customer Care" and render the pen caps unresponsive and unable to function. Customer are instructed to: 1. If customers have the affected product identified above, we are asking you to return the product. We have sent you a return kit, which you should receive shortly. If the return kit does not arrive in the next 7 days, please contact Bigfoot Biomedical Customer Care at 1-551-244-3668 or 1-888-523-3662 (toll-free number). 2. Ensure you have and continue to use a backup diabetes management plan and diabetes supplies if your Bigfoot Unity Pen Cap stops working. 3. As soon as possible, complete and return the Acknowledgement Postcard to acknowledge the understanding of the actions to be taken. o If customer's device experiences Device Error or other product issues in the future or have any questions, contact Bigfoot Biomedical Customer Care at 1-551-244-3668 or 1-888-523-3662 (tollfree number).

DistributionShow details

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

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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