Medtronic recalls Enlite Glucose Sensors for potential inaccurate elevated readings when used with hydroxyurea. Affected units include specific packaging and lot numbers. Consumers should consult the recall notice for details.
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
Medtronic is recalling Enlite Glucose Sensors that may give inaccurate high glucose readings when used by people taking hydroxyurea. This could lead to incorrect diabetes management decisions. The recall affects specific packaging and lot numbers.
The sensor may show falsely high glucose levels when used with hydroxyurea. This could cause incorrect diabetes treatment decisions. The hazard occurs only when hydroxyurea is being taken.
People with diabetes who take hydroxyurea may be affected. Those using the Enlite Glucose Sensor with hydroxyurea are most at risk.
Check for packaging with 'ENLITE PLUS 5PK 23L 1CL' or 'ENLITE PLUS 5PK 2L 1CL' and GTIN numbers listed in the recall notice. The product is intended for use with Medtronic Diabetes glucose monitoring systems.
Look for specific packaging labels and GTIN numbers listed in the recall notice to confirm if your sensor is affected.
The sensor may show inaccurate elevated glucose readings when used with hydroxyurea, an anti-neoplastic drug.
No, but you should check if your sensor is affected by the recall and follow the instructions if needed.
The recall notice does not specify a remedy, so contact Medtronic for further instructions.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1599-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1599-2021 from Medtronic. 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.
