The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1476-2017·Announced 2017-03-22

Medtronic Recalls BNX Fine Needle Aspiration Systems Due to Handle Breakage

Medtronic is recalling 1,096 BNX Fine Needle Aspiration Systems because the handle may break during use.

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 medical device with a structural defect (handle breakage) that poses a risk of harm during use, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Medtronic is recalling 1,096 units of the BNX Fine Needle Aspiration System (22GA), Material/Part# DSN-22-01. The recall is due to a defect where the handle may break during use.

The affected product is distributed in the United States to specific states including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, and WI, as well as in Denmark and Germany. The specific lot number for the recalled units is B000000167.

Consumers and healthcare providers should stop using the affected devices and contact Medtronic for further instructions or a replacement.

The recalled product

Product
BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01
Manufacturer
Medtronic
Category
Medical Device — Needle Aspiration System
Hazard
Affected units
1,096

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 number: B000000167

Distribution

Distributed in 40 states:

Part of a larger recall action

This product is one of 5 recalled by Medtronic 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 5 products in this recall →

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