Cardinal Health Monoject Syringes Recalled Due to Manufacturing Changes
Cardinal Health is recalling all sizes of Monoject sterile syringes—including Luer-Lock and Enteral syringes with ENFit connections—due to manufacturing and rebranding changes. Products distributed across the U.S. and Canada.
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: This is classified as an FDA Class I medical device recall. Per the severity rubric, FDA Class I recalls receive a Critical (5) designation, indicating a reasonable probability of serious adverse health consequences related to the manufacturing and product control concerns identified.
Plain-English summary
Cardinal Health is recalling all sizes of their Monoject sterile Luer-Lock syringes and Monoject sterile Enteral syringes with ENFit connections. The products are being removed due to manufacturing and rebranding efforts. This action represents an expansion of a previous product correction to a complete removal.
The recalled Luer-Lock syringes are available in 1, 3, 6, 12, 20, 35, and 60 mL sizes. The Enteral syringes with ENFit connection are available in 1, 3, 6, 12, 35, and 60 mL sizes. All sizes are being recalled. The products have been distributed throughout the United States and Canada.
Affected individuals and healthcare facilities should immediately stop using these syringes. Contact Cardinal Health for instructions on return, replacement, or disposal of the recalled products. Healthcare providers should review their inventory and remove any affected syringes from use.
The recalled product
- Product
- Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000777T
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
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 (5)
- UDI/DI 50192253025833 (Case)
- 20192253025832 (Box)
- 10192253025835 (Each)
- Lot Numbers: 221101
- 230601
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 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.
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