FDA Medical devices recall ·
Medtronic, Simplera Sensor recall
- Recall number
- Z-0033-2026
- Date
- (initiated May 7, 2025)
- Company / brand
- Medtronic MiniMed, Inc.
18000 Devonshire St, Northridge, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,440 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medtronic, Simplera Sensor, REF: MMT-5100JD1
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # HG81GLZ/ GTIN: 20763000649580
Distribution
US: No distribution OUS: Austria, Belgium, Italy, Spain, Switzerland, United Kingdom
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0033-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.