Medtronic Recalls Thoracic Tactile Probes Due to Sterility Control Issues
Medtronic Navigation is recalling 26,674 thoracic tactile probe kits because returned devices may not have been properly examined for damage to ensure sterility.
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. The hazard involves a potential sterility breach due to a process control failure, but the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Medtronic Navigation, Inc. is recalling 26,674 units of the KIT, 9731427, THORACIC TACTILE PROBES. The recall is due to insufficient control measures to ensure that returned, unused devices were appropriately examined for product and/or package damage, which is necessary to verify sterility.
The affected lots are 6688089, 6095124, and 6095129. These single-use, disposable devices were distributed nationwide.
The source text does not specify specific instructions for consumers or healthcare providers regarding the immediate handling of these devices, nor does it report any illnesses or injuries associated with the recall.
The recalled product
- Product
- KIT, 9731427, THORACIC TACTILE PROBES
- Manufacturer
- Medtronic Navigation, Inc.
- Affected units
- 26,674
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 (1)
- Lot No.: 6688089 6095124 6095129
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 25 recalled by Medtronic Navigation, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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