Medtronic Recalls Biopsy Needle Kits Due to Sterility Control Issues
Medtronic Navigation is recalling 26,674 biopsy needle 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Medtronic Navigation, Inc. is recalling certain single-use, disposable biopsy needle kits (catalog number 9733068, passive). The recall affects 26,674 units distributed nationwide. The specific lot numbers involved are 66516213, 66501413, 66518413, and 66507713.
The recall was initiated because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage. This lack of control raises concerns about the ability to ensure the sterility of the devices.
Healthcare facilities and consumers should check their inventory for the specific lot numbers listed above. If the recalled products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations. No specific instructions for end-users are provided in the source text beyond the identification of the affected lots.
The recalled product
- Product
- BIOPSY NEEDLE KIT, 9733068, PASSIVE
- Manufacturer
- Medtronic Navigation, Inc.
- Category
- Medical Device — Biopsy Needles
- 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.: 66516213 66501413 66518413 66507713
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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