Medtronic SharkCore Fine Needle Biopsy System Recalled for Handle Breakage
Medtronic is recalling SharkCore Fine Needle Biopsy Systems because the handle may break during use. The recall covers 1,096 units distributed in the US and two countries.
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 involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Medtronic is recalling the SharkCore Fine Needle Biopsy System (25GA), Material/Part#: DSC-25-01. The recall is being conducted because the handle of the device may break during use.
A total of 1,096 units are affected by this recall. The 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 number for the recalled product is B000000174.
This recall is classified as Class II by the U.S. Food and Drug Administration. Consumers and healthcare providers should stop using the affected devices and contact Medtronic for further instructions.
The recalled product
- Product
- SharkCore Fine Needle Biopsy System (25GA); Material/Part#: DSC-25-01
- Manufacturer
- Medtronic
- Category
- Medical Device — Biopsy 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: B000000174
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.
See all 5 products in this recall →Related recalls
Same manufacturer · Medtronic
See all →- HighMedtronic Recalls USPACK Suture Kits Due to Potential Seal Defects
FDA (Devices) · 2017-06-21
- HighMedtronic Recalls Best Practice Kits Due to Potential Seal Defects
FDA (Devices) · 2017-06-21
- HighMedtronic Recalls Pacemaker Angio X3 Due to Potential Seal Defect
FDA (Devices) · 2017-06-21
- ModerateMedtronic Recalls Polysorb Sutures Due to Potential Incomplete Seal
FDA (Devices) · 2017-06-21
- SevereMedtronic Recalls Custom Suture Packs Due to Potential Seal Defects
FDA (Devices) · 2017-06-21
Same hazard · structural failure
See all →- High
- ModerateQuantum Ops Recalls ADAPTABLE Beach Chair Surgical Patient Positioners
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Detachment Risk
FDA (Devices) · 2026-10-14
- SeverePacearth Recalls Swing Seats Due to Serious Injury Risk from Falling
CPSC · 2026-10-08
Similar recalls
- ModerateMedtronic Biopsy Needle FPU Kit Recalled for Depth Stop Issue
FDA (Devices) · 2019-12-18
- ModerateMedtronic Passive Biopsy Needle Kit Recall for Depth Stop Issue
FDA (Devices) · 2019-12-18
- HighMedtronic Recalls MAXON Sutures Due to Potential Incomplete Seal
FDA (Devices) · 2017-06-21
- HighBard Max-Core Biopsy Instruments Recalled for Malfunction
FDA (Devices) · 2017-11-01
- HighMedtronic Recalls Biopsy Needle Kits Due to Sterility Control Issues
FDA (Devices) · 2014-11-26
- SevereMedtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
FDA (Devices) · 2019-10-09