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.
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: 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…
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 13,487
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.
Part of a larger recall action
This product is one of 4 recalled by Cardinal Health 200, LLC 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 4 products in this recall →Related recalls
Same manufacturer · Cardinal Health 200, LLC
See all →- SevereCardinal Health Recalls Presource Packs with Medtronic Microstream Components
FDA (Devices) · 2026-10-14
- HighCardinal Health Recalls Gynecological Laparoscopy Kits Due to Handpiece Leakage
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Presource Packs Due to Potential Handpiece Leakage
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Stryker StrykeFlow PS and AHTO Tube Set Kits
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Presource Packs with Leaking Handpieces
FDA (Devices) · 2026-10-07
Same hazard · design defect
See all →- HighUnited Orthopedic Recalls U2 Total Knee System Femoral Offset Bushings
FDA (Devices) · 2026-08-12
- SevereBioFlo DuraMax catheters recalled as Class I over sheath introducer defect
FDA (Devices) · 2026-04-01
- SevereMerit 16F splittable sheath introducer recalled as Class I bulk product
FDA (Devices) · 2026-04-01
- SevereProGuide chronic dialysis catheters recalled as Class I over sheath introducer defect
FDA (Devices) · 2026-04-01
- SevereCentrosFLO hemodialysis catheters recalled as Class I over sheath introducer defect
FDA (Devices) · 2026-04-01
Similar recalls
- SevereMedline Procedure Kits Recalled Due to Defective Plastic Syringes
FDA (Devices) · 2024-08-14
- HighCardinal Health Recalls Presource Kits Contaminated with Needle Particulate
FDA (Devices) · 2017-09-13
- HighCardinal Health surgical kits recalled for potential endotoxin contamination
FDA (Devices) · 2025-01-22
- HighMedical paracentesis procedure kits recalled for syringe leaks and breakage
FDA (Devices) · 2024-08-21
- HighCardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination
FDA (Devices) · 2025-01-22
- HighCardinal Health Presource Kits Recalled for Endotoxin Variability in Sponges
FDA (Devices) · 2026-08-19