Medtronic Guardian Sensor Kit Recall: Inaccurate Glucose Readings with Hydroxyurea
Medtronic recalls Guardian Sensor kits for inaccurate glucose readings when used with hydroxyurea. Affected kits have specific packaging codes; no remedy provided in recall notice.
Lower-risk recall
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
Contact the company
What happened, in plain English
Medtronic is recalling Guardian Sensor kits that may give inaccurate high glucose readings when used with hydroxyurea. This could lead to incorrect diabetes management decisions if the patient is taking this chemotherapy drug. Read more at govinfonow.com/recall/63187-medtronic-guardian-sensor-kit-recall-inaccurate-glucose-readings-with-hydroxyurea.
Source Summary by GovInfoNow · govinfonow.com/recall/63187-medtronic-guardian-sensor-kit-recall-inaccurate-glucose-readings-with-hydroxyurea · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1606-2021
Cite this page
“Medtronic Guardian Sensor Kit Recall: Inaccurate Glucose Readings with Hydroxyurea.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63187-medtronic-guardian-sensor-kit-recall-inaccurate-glucose-readings-with-hydroxyurea. Based on FDA recall #Z-1606-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1606-2021%22&limit=1).
Why it’s dangerous
The Guardian Sensor kit may show falsely high glucose levels when used with hydroxyurea. This could cause patients to take unnecessary insulin or other diabetes medications, leading to dangerous blood sugar levels.
Who’s affected
People with diabetes using Medtronic Guardian Sensor kits who also take hydroxyurea chemotherapy may be affected. Those with diabetes and hydroxyurea use are most at risk.
How to tell if you have this one
Check for packaging with GS3 SEMI 5PK OUS or GTIN 20763000192086, or GS3 OUS with GTIN 20763000358451. The product is not distributed in the US.
- Brand
Medtronic- Product
Medtronic Inc. recalls Medtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging: GS3 SEMI 5PK OUS/ GTIN: 20763000192086- Category
Medical device
All 20 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide distribution.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1599-2021 | Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 5PK 23L 1CL /GTIN: 20643169541706, ENLT PLUS 5PK 2L 1CL PR/ GTIN: 20643169786725, ENLITE PLUS 5PK 23L 1CL/ GTIN: 20763000421292 - Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.; All Lot numbers within active shelf life | 213,110 units |
| Z-1600-2021 | Medtronic REF: MMT-7008B, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 23L 1CL / GTIN: 00643169541719 ENLITE PLUS 2L 1CL PR/ GTIN: 00643169786738 ENLITE PLUS 1PK 23L 1CL/ GTIN: 00763000421304 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.; All Lot numbers within active shelf life | 20,913 units |
| Z-1601-2021 | Medtronic REF: MMT-7020A, Guardian Sensor (3) for the following packaging: GS3 5PK 2L US/ GTIN: 20763000140940 GS3 5PK 2L US/ GTIN: 20763000337005 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.; All Lot numbers within active shelf life | 1,224,032 units |
| Z-1602-2021 | Medtronic REF: MMT-7020B, Guardian Sensor (3) for the following packaging: GS3 1PK 2L US/GTIN: 00763000140779 GS3 1PK 2L US/ GTIN: 00763000337049 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.; All Lot numbers within active shelf life | 302,667 units |
| Z-1603-2021 | Medtronic REF: MMT-7020GA, Guardian Sensor (3) for the following packaging: GS3 5PK US GC/ GTIN: 20763000179629 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.; All Lot numbers within active shelf life | 1,863 units |
| Z-1604-2021 | Medtronic REF: MMT-7020LA, Guardian Sensor (3) for the following packaging: GS3 5PK US/ GTIN: 20763000336985 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.; All Lot numbers within active shelf life | 37,228 units |
| Z-1605-2021 | Medtronic REF: MMT-7020LB, Guardian Sensor (3) for the following packaging: GS3 1PK US/ GTIN: 763000336998 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.; All Lot numbers within active shelf life | 5,571 units |
| Z-1606-2021 | Medtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging: GS3 SEMI 5PK OUS/ GTIN: 20763000192086, 5PK SF NEW GS3 OUS/GTIN: 20763000358451 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.; All Lot numbers within active shelf life | 497,747 units |
| Z-1607-2021 | Medtronic REF: MMT-7020C1 Guardian Sensor (3) for the following packaging: GS3 5PK OUS1/ GTIN: 20643169704071 GS3 5PK 9L OUS1/ GTIN: 20763000243320 GS3 5PK 9L OUS1/ GTIN: 20763000318844 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.; All Lot numbers within active shelf life | 220,661 units |
| Z-1608-2021 | Medtronic REF: MMT-7020C2 Guardian Sensor (3) for the following packaging: GS3 5PK 9L OUS2/ GTIN: 20763000243344 GS3 5PK 9L OUS2/ GTIN: 20763000318868 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.; All Lot numbers within active shelf life | 52,196 units |
| Z-1609-2021 | Medtronic REF: MMT-7020C3 Guardian Sensor (3) for the following packaging: GS3 5PK OUS3/ GTIN: 20643169704118 GS3 5PK 9L OUS3/ GTIN: 20763000243368 GS3 5PK 9L OUS3/ GTIN: 20763000318882 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.; All Lot numbers within active shelf life | 15,393 units |
| Z-1610-2021 | Medtronic REF: MMT-7020C4 Guardian Sensor (3) for the following packaging: GS3 5PK 2L CANADA/ GTIN: 20763000179612 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.; All Lot numbers within active shelf life | 54,211 units |
| Z-1611-2021 | Medtronic REF: MMT-7020C5 Guardian Sensor (3) for the following packaging: GS3 5PK 1L AUS/ GTIN: 20763000252056 GS3 5PK 1L AUS/ GTIN: 20763000414362 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.; All Lot numbers within active shelf life | 68,069 units |
| Z-1612-2021 | Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: GS3 1PK OUS1/ GTIN: 00643169704084 GS3 1PK 9L OUS1/ GTIN: 00763000243333 GS3 1PK 9L OUS1/ GTIN: 00763000318857 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.; All Lot numbers within active shelf life | 111,678 units |
| Z-1613-2021 | Medtronic REF: MMT-7020D2 Guardian Sensor (3) for the following packaging: GS3 1PK 9L OUS2/ GTIN: 00763000243357 GS3 1PK 9L OUS2/ GTIN: 00763000318871 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.; All Lot numbers within active shelf life | 15,162 units |
| Z-1614-2021 | Medtronic REF: MMT-7020D3 Guardian Sensor (3) for the following packaging: GS3 1 PK OUS3/ GTIN: 00643169704121 GS3 1PK 9L OUS3/ GTIN: 00763000318895 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.; All Lot numbers within active shelf life | 13,014 units |
| Z-1615-2021 | Medtronic REF: MMT-7020D4 Guardian Sensor (3) for the following packaging: GS3 1PK 2L CANADA/ GTIN: 00763000179595¿ Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.; All Lot numbers within active shelf life | 12,624 units |
| Z-1616-2021 | Medtronic REF: MMT-7020D5 Guardian Sensor (3) for the following packaging: GS3 1PK 1L AUS/ GTIN 00763000252069 GS3 1PK 1L AUS/ GTIN 00763000414375 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.; All Lot numbers within active shelf life | 15,926 units |
| Z-1617-2021 | Medtronic, REF: MMT-7008C, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 5PK/ GTIN: 20763000252032 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.; All Lot numbers within active shelf life | 1,174 units |
| Z-1618-2021 | Medtronic, REF: MMT-7008D, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 1PK; GTIN: 00763000252045 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.; All Lot numbers within active shelf life | 207 units |
What to do — step by step
Check Product Packaging
Look for specific packaging codes listed in the recall notice.
How this recall unfolded
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
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.
- Official source: FDA Recall #Z-1606-2021 (February 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1606-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.