Bigfoot Unity Diabetes Management System pen caps with firmware 1.3.0 Release (RCAP/LCAP) may show device errors and stop insulin delivery. Affected users should check their product details.
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.
Bigfoot Unity Diabetes Management System pen caps with firmware version 1.3.0 Release (RCAP/LCAP) may show device errors and stop insulin delivery. This could prevent timely treatment for people with diabetes.
The software/firmware issue may cause the insulin pen to become unresponsive and unable to function, potentially leading to a device error. This error could mean users don't have all necessary information to make timely treatment decisions, which is critical for diabetes management.
People using Bigfoot Unity Diabetes Management System pen caps with firmware version 1.3.0 Release (RCAP/LCAP) are affected. Those with diabetes who rely on these pen caps for insulin delivery are at risk.
Check if your pen cap has the model number starting with 'FG-300171' to 'FG-300179' and includes the firmware version 1.3.0 Release (RCAP/LCAP). The product includes insulin pen caps for various insulin types like Humalog, Novolog, Lantus, etc.
Identify your pen cap model by checking the product details listed in the recall notice for specific insulin types and firmware versions.
Reach out to Bigfoot Biomedical for further assistance with the recall process.
The affected firmware version is 1.3.0 Release (RCAP/LCAP) for Bigfoot Unity Diabetes Management System pen caps.
The recall notice does not specify an immediate replacement requirement; users should check their product details and contact Bigfoot Biomedical for guidance.
The recall affects pen caps for various insulin types including Humalog, Novolog, Lantus, Fiasp, and Levmr.
We’ve drafted a message you can send Bigfoot to request your refund or repair — edit it as you like.
Subject: Recall Z-1997-2025 — Bigfoot Bigfoot Hello, I own a Bigfoot that is covered by recall Z-1997-2025 from Bigfoot. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
