FDA Device recall Z-0033-2026
Medtronic, Simplera Sensor, REF: MMT-5100JD1
- FDA Device
- Class II
- ongoing
- Published 2025-10-08
On 2025-10-08 the FDA classified a Class II recall of Medtronic, Simplera Sensor, REF: MMT-5100JD1 by Medtronic Minimed, citing the device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0033-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-07 |
| Published | 2025-10-08 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medtronic Minimed |
| Distribution | n/a |
Product
Medtronic, Simplera Sensor, REF: MMT-5100JD1
Reason
The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
Identifiers
| code_info | Lot # HG81GLZ/ GTIN: 20763000649580 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Medtronic Minimed
- Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062
FDA Device · Class II · 2026-10-14 · Medtronic Minimed - MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712
FDA Device · Class II · 2026-08-26 · Medtronic Minimed - MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW
FDA Device · Class II · 2026-08-26 · Medtronic Minimed - MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782
FDA Device · Class II · 2026-08-26 · Medtronic Minimed - MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
FDA Device · Class II · 2026-07-29 · Medtronic Minimed
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0033-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.