CLASS II ONGOING Device recall · Reported 8 Oct 2025 · FDA Enforcement Report
Medtronic, Simplera Sensor recalled by Medtronic MiniMed
Medtronic MiniMed is recalling Medtronic, Simplera Sensor. The recall was initiated on 7 May 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0033-2026
- FDA event ID
- 96745
- Recalling firm
- Medtronic MiniMed, Northridge, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 May 2025
- FDA classified
- 2 Oct 2025
- Reported
- 8 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 7 May 2025 | Recall initiated by company | |
| 2 Oct 2025 | Classified by FDA | +148 days |
| 8 Oct 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Medtronic, Simplera Sensor, REF: MMT-5100JD1
Where it was distributed
US: No distribution OUS: Austria, Belgium, Italy, Spain, Switzerland, United Kingdom
Questions about this recall
Why was it recalled?
The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
Which lots are affected?
Lot # HG81GLZ/ GTIN: 20763000649580
Where was it sold?
US: No distribution OUS: Austria, Belgium, Italy, Spain, Switzerland, United Kingdom
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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