Medtronic Guardian Sensor 3 Recall for Hydroxyurea Interaction
Medtronic is recalling Guardian Sensor 3 units worldwide because use with hydroxyurea may cause inaccurate high glucose readings.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential harm without confirmed adverse events.
Plain-English summary
Medtronic Inc. is recalling 15,393 units of the Guardian Sensor (3) continuous glucose monitoring sensor. The recall covers specific packaging configurations (GS3 5PK OUS3 and GS3 5PK 9L OUS3) with GTINs 20643169704118, 20763000243368, and 20763000318882. The product is intended for use with Medtronic Diabetes glucose sensing systems to continuously monitor glucose levels in persons with diabetes. The recall applies to all lot numbers within the active shelf life and involves worldwide distribution.
The recall is issued because using the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug, could result in inaccurate elevated sensor glucose readings. This interaction may lead to incorrect glucose data for patients using the device.
Consumers and healthcare providers should stop using the affected sensors if they are currently taking hydroxyurea. Medtronic has not distributed this specific product within the United States, but the recall is global. Users should contact Medtronic for further instructions on how to proceed.
The recalled product
- Product
- 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…
- Manufacturer
- Medtronic Inc.
- Affected units
- 15,393
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lot numbers within active shelf life
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 20 recalled by Medtronic Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 20 products in this recall →Related recalls
Same manufacturer · Medtronic Inc.
See all →- HighMedtronic Sphere-9 Catheter may cause ventricular fibrillation with Biotronik ICDs
FDA (Devices) · 2026-05-06
- HighVenous stents recalled over a nitinol anomaly that reduces deployed diameter
FDA (Devices) · 2026-01-21
- ModerateKidney tests recalled for distribution without premarket approval or clearance
FDA (Devices) · 2025-12-10
- HighSmartSync Patient Connector limited the window to abort high voltage therapy
FDA (Devices) · 2025-07-30
- HighCareLink SmartSync limited the window to abort a high voltage therapy
FDA (Devices) · 2025-07-30
Same hazard · inaccurate reading
See all →- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
- HighMidmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings
FDA (Devices) · 2026-09-30
- HighMidmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings
FDA (Devices) · 2026-09-30
- HighMidmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings
FDA (Devices) · 2026-09-30
- HighMidmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings
FDA (Devices) · 2026-09-30
Similar recalls
- HighMedical Device Recall: Guardian 4 Glucose Sensor Manufacturing Defect
FDA (Devices) · 2024-02-14
- ModerateMedtronic MiniMed Guardian Monitor Recall for Water Resistance Issue
FDA (Devices) · 2014-08-20
- SevereMedtronic MiniMed 670G Insulin Pumps Recalled for Battery Connection Defect
FDA (Devices) · 2020-12-09
- ModerateMedtronic Guardian Real-Time Monitor Recalled for Finnish Translation Error
FDA (Devices) · 2015-09-02
- HighMedtronic Guardian Connect App Recalled for Silent Operating System Shutdowns
FDA (Devices) · 2019-05-15
- HighMedtronic MiniMed 630G Insulin Pump Recalled for Battery Connection Defect
FDA (Devices) · 2020-12-09