Cardinal Health Monoject Syringes and Enteral Syringes Removed
Cardinal Health is removing all Monoject sterile syringes and enteral syringes due to manufacturing changes and rebranding efforts. These products are distributed across the U.S. and Canada.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recalls warrant a minimum severity score of 4 (Severe) per regulatory guidance. The source contains no reports of injuries, illnesses, or deaths from these products.
Plain-English summary
Cardinal Health is removing all Monoject sterile Syringe Luer-Lock (all sizes) and Monoject sterile Enteral Syringes with ENFit connection (all sizes) from distribution. This includes Luer-Lock syringes in 1, 3, 6, 12, 20, 35, and 60 mL, and ENFit syringes in 1, 3, 6, 12, 35, and 60 mL. The removal is due to manufacturing changes and rebranding efforts.
The affected lot numbers are 221201, 221202, 221203, 230201, 230202, 230203, 230204, 230205, and 230601. These products have been distributed nationwide in the United States and Canada.
Healthcare providers and consumers who have these products should contact Cardinal Health for guidance. This is an FDA Class I recall.
The recalled product
- Product
- Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Syringes
- Hazard
- manufacturing-defect
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 (12)
- UDI/DI 50192253034538 (Case)
- 20192253034537 (Box)
- 10192253034530 (Each)
- Lot Numbers: 221201
- 221202
- 221203
- 230201
- 230202
- 230203
- 230204
- 230205
- 230601
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27