Z-0776-2023 Class II Ongoing
FDA device recall Z-0776-2023 was initiated by Medtronic MiniMed on Nov 21, 2022 and is designated Class II. Reason for recall: An app, part of a continuous glucose monitoring system, for use with smartphone devices may automatically log out from CareLink, then the app is not able to upload data. When logged out, linked care… The recall status is ongoing. Affected quantity: 3235.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 11, 2023
- Initiation Date
- Nov 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3235
Product Description
Reason for Recall
Distribution Pattern
OUS: Austria, Belgium, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Kazakhstan, Kuwait, Luxembourg, Moldova, Republic of, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0776-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026