The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0658-2020·Announced 2019-12-18

Medtronic Biopsy Needle FPU Kit Recalled for Depth Stop Issue

Medtronic Navigation is recalling Biopsy Needle FPU Kits because the depth stop may not tighten securely, 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. The stated hazard is a delay in surgery rather than direct physical injury, and no injuries or illnesses are reported in the source text.

Plain-English summary

Medtronic Navigation, Inc. is recalling Biopsy Needle FPU Kits (Product # 9731754, UDI: 00643169341517). The affected lots are 0009665221, 0009709452, and 0009960538. Each kit contains 12 disposable biopsy needles.

The recall is 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 tightened. This defect could result in a delay in surgery.

The products were distributed to facilities in all 50 U.S. states and the District of Columbia. No distribution outside the United States is reported. The source text does not specify the number of affected units or report any injuries or illnesses.

The recalled product

Product
Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517
Manufacturer
Medtronic Navigation, Inc.
Category
Medical Device — Biopsy Needle
Hazard
Affected units
12

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 Numbers: 0009665221 0009709452 0009960538

Distribution

Distributed in 49 states:

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.

See all 3 products in this recall →

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