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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.

Class I - Dangerous
🏥 Medical Devices Recalled: May 21, 2025 BIGFOOT BIOMEDICAL Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
BIGFOOT BIOMEDICAL
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1997-2025