Agency classClass IOur severity:Critical FDA (Devices)·Z-0310-2025·Announced 2024-11-20

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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. 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
Affected units: 371,326

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.

Same manufacturer · Cardinal Health 200, LLC

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Same hazard · device incompatibility