Medtronic Midas Rex Dissecting Tools Recalled for Labeling Errors
Medtronic is recalling 81 Midas Rex Dissecting Tools due to incorrect color coding and attachment references on the labeling.
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: The recall is classified as FDA Class II, and the hazard is a labeling error (incorrect color coding and references) without reported injuries, fitting the 'Moderate' criteria for minor labeling errors or low-risk issues.
Plain-English summary
Medtronic Sofamor Danek USA, Inc. is recalling 81 units of the Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. (Catalog Number 10BA40D, Lot Number H5237248). These tools are intended for use in neurosurgery.
The recall was initiated because the product labeling included incorrect color coding and attachment references. This labeling error could potentially lead to the use of the wrong tool or attachment during a procedure.
The affected products were distributed in France, Ireland, the Netherlands, Portugal, Switzerland, and the United Kingdom. Healthcare providers and facilities that have received these specific tools should stop using them and contact Medtronic for further instructions.
The recalled product
- Product
- Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
- Hazard
- Affected units
- 81
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)
- Product Catalog Number: 10BA40D
- Lot Number: H5237248
Distribution
Distribution scope not specified by the agency.
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