Medtronic, Simplera Sensor, REF: MMT-5100JD1 recallZ-0033-2026 · Medtronic MiniMed, Inc. · initiated May 7, 2025
Class II Open, Classified All recalls posted in October 2025
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic MiniMed, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
FDA root cause category: Process design
What the company is doing
On May 7, 2025, Medtronic issued a "Urgent Field Safety Notice" to affected consignees. Medtronic asked consignees to take the following actions: 1. Verify if the sensors you currently have are from the impacted lot. 2. If you have a Simplera" sensor from the impacted lot, do not use this Simplera" sensor and dispose of it according to local regulations. 3. Please contact our helpline/your Medtronic contact at 01923 205167 to request a replacement. 4. Please acknowledge that you have read and understood this notification and have followed the actions listed in this letter, even if your sensor is unaffected, or if you do not have any sensors from the affected lot.
Recall details
- Recall number
- Z-0033-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- May 7, 2025
- Posted by the FDA
- Oct 2, 2025
- Recalling firm
- Medtronic MiniMed, Inc.
- Quantity
- 1,440 units
- Product code
- MDS
- FDA submissions
- P160007
- Distribution
- US: No distribution OUS: Austria, Belgium, Italy, Spain, Switzerland, United Kingdom
Product description
Medtronic, Simplera Sensor, REF: MMT-5100JD1
Code information (models, lots, serial numbers)
Lot # HG81GLZ/ GTIN: 20763000649580
Other devices under the same FDA submission
2 devices cleared under P160007 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Guardian™ Connect App CSS7200Medtronic Minimed, Inc. · Sensor, glucose, invasive1 recall0 reports
- Guardian™ Sensor (3) MMT-7020AMedtronic Minimed, Inc. · Automated insulin dosing , threshold suspend6 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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