Z-0121-2024Class II

SenSight Connector Plug, Model Number B31061

Name: Z-0121-2024 SenSight Connector Plug, Model Number B31061
Creator: Medtronic Neuromodulation
Published: 2023-01-20
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2023-01-20 / Open, Classified / root cause: labeling and UDI

FDA source

Medtronic Neuromodulation began a recall of SenSight Connector Plug, Model Number B31061 on 2023-01-20. FDA classified it as Class II and gives the reason as "Medtronic is requesting return of a small number of units of the SenSight Connector Plug, Model B31061, due to a discrepancy in the Use By Date (UBD) printed on the label". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0121-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-01-20
Posted: 2023-10-18
Recalling firm: Medtronic Neuromodulation
Product: SenSight Connector Plug, Model Number B31061.
Product code: MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Reason for recall: Medtronic is requesting return of a small number of units of the SenSight Connector Plug, Model B31061, due to a discrepancy in the Use By Date (UBD) printed on the label.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Medtronic issued a MEDICAL DEVICE REMOVAL notice to its consignees on 01/20/2023 by mail. Consignees were asked to return any affected product they may have, and to forward this notification to those who need to be aware within the organization or to any location which the devices have been transferred.
Quantity in commerce: 65 devices
Distribution: US Nationwide Distribution
Product codes and lots: GTIN 00763000426576, Lot Number 082U30721

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0121-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0121-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-25	2023-10-18

Product code MHY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)