Medtronic Passive Biopsy Needle Kit Recall for Depth Stop Issue
Medtronic is recalling 10,448 Passive Biopsy Needle Kits because a manufacturing issue may cause depth stops to fail, potentially delaying surgery.
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, but the source text explicitly states the hazard is a potential delay in surgery with no reported injuries or illnesses, fitting the criteria for a moderate, precautionary recall.
Plain-English summary
Medtronic Navigation, Inc. is recalling 10,448 disposable Passive Biopsy Needle Kits. The recall involves specific lot numbers and UDIs (00643169030121 and 00643169702943) distributed across all 50 US states, the District of Columbia, and numerous international locations.
The recall was initiated due to a manufacturing issue affecting the biopsy needle depth stop. The firm has determined that some depth stops may not tighten securely to the biopsy needle when adjusted. This defect could result in a delay in surgery.
The source text does not report any injuries, illnesses, or deaths associated with this recall. Consumers and healthcare providers should stop using the affected products and contact Medtronic Navigation, Inc. for further instructions.
The recalled product
- Product
- Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943
- Manufacturer
- Medtronic Navigation, Inc.
- Category
- Medical Device — Biopsy Needles
- Affected units
- 10,448
Distribution
Part of a larger recall action
This product is one of 3 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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