FDA Medical Device Recalls (openFDA)
Medtronic Inc.: 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.
- Recall number
- Z-3201-2018
- Recalling firm
- Medtronic Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2018-05-16
- Posted
- not on file
- Terminated
- 2020-06-30
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- The firm, Medtronic, sent an "URGENT MEDICAL DEVICE RECALL- CONTOUR"PLUS LINK 2.4 Meter (MMT-1151SK - Batch# MD04M051P) Incorrect Unit of Measure" letter to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: A. Confirm if the Model (REF) of your meter is MMT-1151SK and the batch (LOT) number is MD04M051P. B. If the REF and LOT match this notice, stop using the CONTOUR"PLUS LINK 2.4 meter immediately. C. Call your local Helpline and let the customer service team know you received a notice stating you may have a CONTOUR"PLUS LINK 2.4 meter with the incorrect unit of measure. D. Return your recalled CONTOUR"PLUS LINK 2.4 meter to Medtronic by following the instructions provided by the Helpline representative. Medtronic will provide a free replacement. If you have any questions, contact the Program Manager, Field Corrective Action at 818-576-4700.
- Quantity
- 2
- Distribution
- International Distribution to Slovakia only.
- Lot, serial or model codes
- Lot# MD04M051P S/N# BG1245623B and S/N# BG1245624B
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QBJ
- Firm FEI
- 3003166194
- Firm city
- Northridge
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28