Presource Neurological Surgical Kits Recalled for Syringe Design Defect
Cardinal Health is recalling Presource neurological surgical kits containing defectively designed syringes that may cause inaccurate dosing or device leakage. The recall affects 13,487 kits distributed nationwide.
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 recall of medical devices with potential for patient harm (inaccurate dosing in neurological procedures and device leakage), but no injuries or illnesses have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score at 3 (High).
Plain-English summary
Cardinal Health 200, LLC is recalling Presource neurological surgical kits and trays containing syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. These syringes were included as components in Merit Medical kit components that are part of the Presource finished kits. The recall affects 13,487 units distributed nationwide.
The Shenli syringes in these kits may contain a significant modification in design that could alter the safety or effectiveness of the finished kit product. This potential design change creates a risk of patient harm through inaccurate dosing and device leakage. Per FDA guidance, these syringes cannot be distributed for medical use.
Cardinal Health is following FDA recommendations regarding the disposition of the affected kits.
The recalled product
- Product
- Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog Number SAN29NRCC1; 3) Neurological Tray, Catalog Number SAN29NRCC2; 4) Neurological Tray, Catalog Number SAN29NRCC3; 5) Neurological Tray, Catalog Number SAN
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- design-defect
- inaccurate-dosing
- device-leakage
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 (20)
- 1) SAN29NICCA
- UDI/DI (CS/EA) 50197106228256/10197106228258
- Lot Numbers: 36457
- 2) SAN29NRCC1
- UDI/DI (CS/EA) 50888439733509/10888439733501
- Lot Numbers: 381858
- 3) SAN29NRCC2
- UDI/DI (CS/EA) 50195594325563/10195594325565
- Lot Numbers: 685160
- 4) SAN29NRCC3
- UDI/DI (CS/EA) 50195594622532/10195594622534
- Lot Numbers: 801575
- 5) SAN29NRCCA
- UDI/DI (CS/EA) 50888439636374/10888439636376
- Lot Numbers: 28512
- 42260
- 69660
- 85314
- 103254
- 127809
Distribution
Distributed nationwide across the United States.
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