Monoject Insulin Syringes Recalled for Incompatibility with Needleless IV Connectors
Cardinal Health recalled approximately 371,326 Monoject U-100 insulin syringes due to incompatibility with needleless IV connectors. Affected units should not be used for IV push insulin administration via these connectors.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I classification indicates a serious probability of adverse health consequences and qualifies for Critical severity per the regulatory rubric. IV insulin administration defects carry inherent risk of patient harm.
Plain-English summary
Cardinal Health has recalled certain lots of Monoject U-100 1 mL insulin syringes with Luer-Lock and Tip Cap in soft pack format. The recalled products are identified by specific lot numbers and universal device identifiers (UDIs), with approximately 371,326 units distributed nationwide.
The syringes have demonstrated incompatibility with needleless intravenous (IV) connectors, which could compromise the proper administration of insulin via IV push and potentially affect patient treatment.
Healthcare providers and facilities should immediately cease use of the affected lots (221201, 230201, 230202) for IV push insulin administration via needleless connectors. Inventory should be reviewed to identify and quarantine affected units, and staff should be informed of this incompatibility to prevent accidental use.
The recalled product
- Product
- Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Insulin Syringe
- Hazard
- device-incompatibility
- IV-administration-risk
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 (9)
- UDI/DI 10192253034783 (EA)
- Lot Number 221201
- exp. 2027-11-30
- UDI/DI 20192253034780 (BX)
- Lot Number 230201
- exp. 2028-01-31
- UDI/DI 50192253034781 (CS)
- Lot Number 230202
- exp. 2028-02-01
Distribution
Distributed nationwide across the United States.
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