Medtronic Recalls BNX Fine Needle Aspiration Systems Due to Breakage Risk
Medtronic is recalling 1,096 units of 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 is classified as FDA Class II, and the hazard involves a structural failure (handle breakage) during use which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Medtronic is recalling 1,096 units of the BNX Fine Needle Aspiration System (19GA), Material/Part # DSN-19-01. The recall is being conducted because the handle of the device may break during use.
The affected products were distributed in the United States to 38 states and the District of Columbia, as well as to Denmark and Germany. The specific lot numbers involved in this recall are B000000176 and B000000181.
Consumers and healthcare providers should stop using the affected devices immediately and contact Medtronic for further instructions or a replacement.
The recalled product
- Product
- BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01
- Manufacturer
- Medtronic
- 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 (2)
- Lot Number: B000000176
- B000000181
Distribution
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.
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