Medtronic Arterial Cannula Recall Due to Incorrect Labeling
Medtronic Perfusion Systems is recalling Select Series Angled Tip Arterial Cannulas (Model 72422) due to incorrect labeling. The recall involves 440 units distributed nationwide.
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 for incorrect labeling with no reported illnesses or injuries. The hazard is limited to labeling errors rather than a functional product defect, which constitutes a Moderate (2) severity rating per the rubric.
Plain-English summary
Medtronic Perfusion Systems is recalling Select Series Angled Tip Arterial Cannulas, Model 72422 (22 Fr), due to incorrect labeling affecting seven manufactured lots. The recall impacts 440 units that have been distributed nationwide and internationally.
The following lot numbers have been identified: 2023071075 and 202309C075. No illnesses or injuries have been reported related to this recall.
Healthcare facilities and providers should check their inventory against the identified lot numbers. Those with affected units should contact Medtronic Perfusion Systems for further guidance.
The recalled product
- Product
- Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
- Affected units
- 440
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 (3)
- Model 72422 UDI-DI: 20643169485970
- Lot Numbers: 2023071075
- 202309C075
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Medtronic Perfusion Systems 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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