Bard Mission Biopsy Instrument Kit cannula and needle incompatibility
Bard Mission Disposable Biopsy Instrument Kit has an incompatibility defect where the cannula is oversized relative to the needle, preventing proper insertion and tissue access. This could cause procedure delays and insufficient tissue collection.
What this means for you
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: This is an FDA Class II medical device recall for a structural defect where the cannula and needle are incompatible in size, preventing the instrument from functioning properly. This is a risk-of-harm product—the defect prevents proper tissue access during biopsies, which could result in inadequate samples and missed diagnoses.
Plain-English summary
Bard Peripheral Vascular Inc is recalling the Bard Mission Disposable Core Biopsy Instrument Kit. The recalled instruments include model REF 2010MSK (20G x 10 cm) and REF 2016MSK (20G x 16 cm). A total of 4,120 units were distributed nationwide throughout the United States, as well as to Belgium, Canada, and Australia.
These instruments have a manufacturing defect in which the internal diameter and length of the coaxial cannula exceed the external diameter and length of the biopsy needle. This size incompatibility prevents the biopsy needle from fitting properly into the coaxial cannula.
The defect prevents the needle from properly accessing the target tissue, which could result in procedure delays and insufficient tissue sample collection. Affected patients may require repeat procedures to obtain an adequate tissue sample.
The recalled product
- Product
- Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM
- Manufacturer
- Bard Peripheral Vascular Inc
- Affected units
- 4,120
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)
- REF/UDI-DI/Lot (Expiration Date): 2010MSK/00801741097089/0001445946(11/28/2024)
- 2016MSK/00801741097096/1458844(02/28/2025)
Distribution
Related recalls
Same manufacturer · Bard Peripheral Vascular Inc
See all →- HighCatheter cutdown trays recalled over damage to the outer tray
FDA (Devices) · 2026-02-25
- HighDrainage catheter trays recalled over safety indicators showing the wrong position
FDA (Devices) · 2025-12-17
- ModerateVein ablation generators recalled over software falsely flagging working catheters
FDA (Devices) · 2025-10-08
- CriticalRotarex Atherectomy Catheter Recalled for Helix Fracture Risk
FDA (Devices) · 2025-03-12
- HighBard Marquee Biopsy Instruments Recalled for Potential Needle Detachment
FDA (Devices) · 2024-11-27
Same hazard · device incompatibility
See all →- CriticalMonoject Insulin Syringes Recalled for Incompatibility with Needleless IV Connectors
FDA (Devices) · 2024-11-20
- HighPERIFIX epidural kits recalled for incompatible filter straw connectors
FDA (Devices) · 2024-02-28
- SevereEnteral Syringes Recalled for Incompatibility with Feeding Pumps
FDA (Devices) · 2024-02-14
- SevereCardinal Health Enteral Syringes Recalled for Pump Incompatibility
FDA (Devices) · 2024-02-14
- SevereCardinal Health Monoject Enteral Syringes Recalled for Pump Incompatibility
FDA (Devices) · 2024-02-14