CLASS II Device recall · Reported 26 Sep 2018 · FDA Enforcement Report
Contour Plus Link 4, Product recalled by Medtronic
Medtronic is recalling Contour Plus Link 4, Product, distributed nationwide in the US. The recall was initiated on 16 May 2018 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-3201-2018
- FDA event ID
- 80685
- Recalling firm
- Medtronic, Northridge, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 May 2018
- FDA classified
- 19 Sep 2018
- Reported
- 26 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 16 May 2018 | Recall initiated by company | |
| 19 Sep 2018 | Classified by FDA | +126 days |
| 26 Sep 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CONTOUR PLUS LINK 2.4 meter with an incorrect unit of measure was included into meter kits and distributed. This meter contains the incorrect unit of measure mg/dL instead of mmol/L.
Product as listed by the FDA
Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glucose monitoring system Contour Plus LINK 2.4 wireless blood glucose monitoring system (glucometer, test strips and control solution) is designed for self-testing by persons with diabetes and the monitoring of glucose concentrations for quantitative glucose measurement in fresh capillary full blood removed from the user's fingertips or palms. It is only for in vitro diagnostic use.
Where it was distributed
International Distribution to Slovakia only.
Questions about this recall
Is Contour Plus Link 4, Product recalled?
Yes. Medtronic recalled Contour Plus Link 4, Product on 16 May 2018. The recall is Class II and its status is Terminated. Recall number Z-3201-2018.
Why was it recalled?
CONTOUR PLUS LINK 2.4 meter with an incorrect unit of measure was included into meter kits and distributed. This meter contains the incorrect unit of measure mg/dL instead of mmol/L.
Which lots are affected?
Lot# MD04M051P S/N# BG1245623B and S/N# BG1245624B
Where was it sold?
International Distribution to Slovakia only.
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 21 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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