Carefusion Recalls Jamshidi Needle Biopsy Devices Due to Packaging Integrity Concerns
Carefusion 2200 Inc is recalling 790 units of Jamshidi Needle Biopsy devices because the integrity of the sterile packaging is potentially compromised.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a potential compromise in sterile packaging integrity without reporting specific illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Carefusion 2200 Inc is recalling 790 units of Jamshidi Needle Biopsy devices. The affected products include sterile needles in 15G x 100mm, 16G x 100mm, 17G x 100mm, and 16G x 70mm configurations. The recall is being conducted because the integrity of the sterile packaging is potentially compromised.
The affected products were distributed nationwide in the United States and internationally to Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, the Netherlands, New Zealand, the Philippines, Singapore, South Africa, Taiwan, Thailand, the United Arab Emirates, and Vietnam. Specific product codes and lot numbers are SN1015X (Lot 0000840334), SN1016X (Lot 0000848028), SN1017X (Lot 0000848018), and SN7016X (Lot 0000848017).
Healthcare providers and consumers should stop using the affected Jamshidi Needle Biopsy devices and contact Carefusion 2200 Inc for further instructions or a return.
The recalled product
- Product
- JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP]; STERILE;
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 790
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 (4)
- Product Code: SN1015X / LOT 0000840334
- Product Code: SN1016X / LOT 0000848028
- Product Code: SN1017X / LOT 0000848018
- Product Code SN7016X / LOT 0000848017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Carefusion 2200 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 6 products in this recall →Related recalls
Same manufacturer · Carefusion 2200 Inc
See all →- HighEndoscopic surgical clamp recalled for defective rotation knob
FDA (Devices) · 2023-08-23
- HighSurgical Clamp Recall: Rotation Knob May Crack or Break
FDA (Devices) · 2023-08-23
- HighEndoscopic surgical graspers recalled for potential rotation knob cracking
FDA (Devices) · 2023-08-23
- HighEndoscopic Surgical Dissectors Recalled for Potential Rotation Knob Cracking
FDA (Devices) · 2023-08-23
- HighEndoscopic surgical graspers recalled for potential rotation knob failure
FDA (Devices) · 2023-08-23
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighJamshidi Bone Marrow Biopsy Needles Recalled for Packaging Seal Defects
FDA (Devices) · 2021-08-18
- HighBecton Dickinson Recalls Jamshidi Bone Marrow Biopsy Needles Due to Sterility Concerns
FDA (Devices) · 2019-09-04
- HighBard Jamshidi Evolve Bone Marrow Needle Recall Due to Open Packaging
FDA (Devices) · 2021-08-18
- HighBard Jamshidi Bone Marrow Biopsy Needle Recalled for Sterility Compromise
FDA (Devices) · 2020-04-15
- HighBiopsy Needle Recall Due to Compromised Sterility Assurance
FDA (Devices) · 2021-09-29
- HighSoft Tissue Biopsy Needles Recalled for Potential Sterility Compromise
FDA (Devices) · 2021-09-29