Filing Flows › Medtronic (MDT) › Recalls, complaints & regulation
Medtronic (MDT): recalls, EPA violations and clinical trials
Medtronic (MDT) beyond its filings: 70 recalls in the last 12 months (432 in five years, 154 Class I); 3 EPA-regulated facilities in violation, $118K in penalties over five years; 101 active clinical trials.
Latest recalls
- 2026-10-28 · FDA device · Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, Rxonly
- 2026-10-28 · FDA device · Medtronic NDI Passive Spheres REF: 8801075, Sterile EO, 5/Tray 12 Pk., Rxonly
- 2026-10-28 · FDA device · Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600 (iOS), MMT-8601 (Android) Software Version: Software version 1.2.1
- 2026-10-28 · FDA device · InterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030 ISTM MICRO PERC 3560030
- 2026-10-28 · FDA device · Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly
- 2026-10-28 · FDA device · CareLink Clinic, REF: MMT-7350
- 2026-10-28 · FDA device · Medtronic NDI Passive Spheres REF: 8801074, Sterile EO, 4/Tray 12 Pk., Rxonly
- 2026-10-28 · FDA device · InterStim SureScan MRI Leads 978A1 & 978B1: LEAD 978A128 ISTM MICRO 28CM SSMRI TINED 978A128 LEAD 978A133 ISTM MICRO 33CM SSMRI TINED 978A133 LEAD 97
EPA facilities in violation
| Facility (as registered) | City | Status | Penalties |
|---|---|---|---|
| MEDTRONIC | Eatontown Boro, NJ | Violation Identified | — |
| COVIDIEN LP | Augusta, GA | Violation Identified | — |
| COVIDIEN | Norfolk, NE | Violation Identified | — |
Facilities in the EPA's ECHO register whose registered name matches the company's; a facility can belong to another business of the same name.
Medtronic's latest quarter
Medtronic, Q1 FY27: revenue $9.8B (+14% year over year), operating margin 18.1%, net earnings $1.5B, operating cash flow $1.8B. The chart follows the revenue to costs, profit and cash.
Questions
Has Medtronic had any recalls?
432 recalls on file over five years from the FDA, CPSC and NHTSA; 70 in the last 12 months.
Has Medtronic been fined by the EPA?
The 91 EPA-regulated facilities on file under its name drew $118K in penalties over five years; 3 are in violation now.
How many clinical trials does Medtronic have?
101 active studies on ClinicalTrials.gov, 1 in phase 3.
Updated Nov 8, 2026. Read automatically from SEC filings and public data; errors are possible. Not investment advice.