SenSight Connector Plug Recalled for Use By Date Label Discrepancy
Medtronic Neuromodulation is recalling 65 units of the SenSight Connector Plug, Model B31061, due to a discrepancy in the Use By Date printed on the device label. The company is requesting return of affected units.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a minor labeling error where the Use By Date is printed incorrectly on the device label. No illnesses, injuries, or adverse events have been reported. The issue is administrative in nature, not a functional safety defect.
Plain-English summary
Medtronic Neuromodulation is recalling the SenSight Connector Plug, Model Number B31061. The recall involves 65 devices distributed nationwide in the United States. The devices are identified by GTIN 00763000426576 and Lot Number 082U30721.
The recall has been initiated due to a discrepancy in the Use By Date (UBD) printed on the device label. The manufacturer has not reported any illnesses, injuries, or adverse events related to this labeling error.
Medtronic Neuromodulation is requesting the return of affected units. Healthcare facilities and users in possession of devices from the affected lot should contact the manufacturer for return instructions and replacement devices.
The recalled product
- Product
- SenSight Connector Plug, Model Number B31061.
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 65
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- GTIN 00763000426576
- Lot Number 082U30721
Distribution
Distributed nationwide across the United States.
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