Jamshidi Bone Marrow Biopsy Tray Recalled for Misbranding
Bard Peripheral Vascular Inc is recalling an Economy Jamshidi Bone Marrow Biopsy and Aspiration Tray due to misbranding. A total of 360 devices were distributed to healthcare facilities across multiple U.S. states.
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: FDA Class II recall due to misbranding of a bone marrow biopsy device. Misbranding of medical devices used in invasive procedures presents risk of harm from incorrect labeling or instructions for use, meeting the rubric criterion for high-risk products even without reported injuries.
Plain-English summary
Bard Peripheral Vascular Inc is recalling the Economy Jamshidi Bone Marrow Biopsy and Aspiration Tray (Catalog # BEK4511) due to misbranding of the distributed products. The product is designed for bone marrow biopsy and aspiration procedures on the posterior iliac crest and includes an 11 gauge 4-inch biopsy/aspiration needle and a 15 gauge adjustable aspiration needle.
Approximately 360 devices were distributed in quantities of 10 per tray to healthcare facilities in California, Georgia, Hawaii, Illinois, Indiana, Louisiana, Missouri, Mississippi, North Carolina, Ohio, Pennsylvania, Puerto Rico, Texas, Utah, Virginia, and Washington.
Patients who have had or are scheduled for bone marrow biopsy or aspiration procedures should contact their healthcare provider to determine if they received this product and for guidance on any necessary next steps.
The recalled product
- Product
- Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, 15 G Aspiration Needle (Adjustable Length 15/16" -1-7/8") (24mm-48mm) sterile, For Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion. O
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- Affected units
- 360
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 (3)
- Cat No.: BEK4511
- Lot /Serial No.: 0001379055
- UDI # (01)50885403057265(17)211231(10)0001379055
Distribution
Part of a larger recall action
This product is one of 2 recalled by Bard Peripheral Vascular 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 2 products in this recall →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 · mis labeling
See all →- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- HighByron White A-L Complex Herbal Supplement Recalled for Undeclared Walnut
FDA (Food) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02