Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 23, 2020
The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.
As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuous Monitoring Glucose system stopped automatically uploading data to t…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic Inc. recalled The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a… - a moderate-severity action.
The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a… was recalled by Medtronic Inc. in September 23, 2020. Reason: As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuo…. Check the official notice for the remedy. Verify recall #Z-2980-2020 with the FDA Devices before acting.
The recall
Medtronic Inc. issued this moderate-severity FDA Devices recall-As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuo….
- Moderate
- severity level
- Class II
- classification
- September 23, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2980-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2980-2020) was formally reported on September 23, 2020, with the manufacturer initiating the action on July 15, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtronic Inc. is listed as the recalling firm, operating out of Northridge, CA. Federal records list the affected scope as 3,588 users.
The documented reason for this recall is: As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuous Monitoring Glucose system stopped automatically uploading data to the website. Distribution data in the federal record shows the product reached: International distribution including in the countries of EMEA - Austria, Belgium, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Kuwait, Latvia, Luxembour…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
3,588 users
Related Recalls
6
3 from same agency
Product description
The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.
Reason for recall
As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuous Monitoring Glucose system stopped automatically uploading data to the website.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2980-2020 |
| Date reported | September 23, 2020 |
| Date initiated | July 15, 2020 |
| Recalling firm | Medtronic Inc. |
| Firm location | Northridge, CA |
| Affected scope | 3,588 users |
| Distribution | International distribution including in the countries of EMEA - Austria, Belgium, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Kuwait, Latvia, Luxembourg, The Netherlands, … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2980-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.. Recalled by Medtronic Inc.. Units affected: 3,588 users.
Why was this product recalled? ▼
As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuous Monitoring Glucose system stopped automatically uploading data to the website.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 23, 2020. Severity: Moderate. Recall number: Z-2980-2020.
Where was the recalled product distributed? ▼
Distribution: International distribution including in the countries of EMEA - Austria, Belgium, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Kuwait, Latvia, Luxembourg, The Netherlands, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, and United Kingdom. Latin America- Chile, Colombia and Mexico Asia Pacific (APAC) - Australia, India, Japan, The Republic of Korea, Malaysia, New Zealand, Russia Federation, Singapore, Thailand, and Vietnam. Asia - Hong Kong North America - Canada.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2980-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 23, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.