Cardinal Health Monoject Sterile Syringes Removed Due to Manufacturing Change
Cardinal Health 200, LLC is recalling all sizes of Monoject brand sterile syringes (both Luer-Lock and ENFit enteral types) due to manufacturing and rebranding changes. The recall expands previous correction actions to a complete product removal.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is a Class I FDA medical device recall. FDA Class I classifications mandate a minimum severity score of 4 per the regulatory severity rubric. No deaths, serious injuries, or hospitalizations are reported in the source material, which prevents a higher critical classification.
Plain-English summary
Cardinal Health 200, LLC is recalling all sizes of Monoject brand sterile syringes, including Luer-Lock models (1, 3, 6, 12, 20, 35, and 60 mL) and enteral syringes with ENFit connection (1, 3, 6, 12, 35, and 60 mL), due to a change in manufacturing and rebranding efforts.
The recall expands Cardinal Health's previous product correction actions to a complete product removal. Affected lot numbers include 230701 and 230501. These products have been distributed throughout the United States and Canada.
Individuals or healthcare facilities in possession of these syringes should discontinue use immediately and contact Cardinal Health 200, LLC for instructions on return or replacement of affected products.
The recalled product
- Product
- Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Syringes
- 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 26971564466206 (Case)
- 16971564466209 (Box)
- 06971564466202 (Each)
- Lot Numbers: 230701
- 230501
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.
See all 13 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 · manufacturing defect
See all →- ModerateBoston Scientific Recalls Direxion Torqueable Microcatheters Due to Coating Defects
FDA (Devices) · 2026-10-28
- ModerateBoston Scientific Recalls Defective Direxion Torqueable Microcatheters
FDA (Devices) · 2026-10-28
- ModerateBoston Scientific Recalls Defective Direxion Torqueable Microcatheters
FDA (Devices) · 2026-10-28
- ModerateBoston Scientific Recalls Direxion Torqueable Microcatheters Due to Coating Defects
FDA (Devices) · 2026-10-28
- ModerateBoston Scientific Recalls Direxion Torqueable Microcatheters for Coating Defects
FDA (Devices) · 2026-10-28
Similar recalls
- SevereMonoject 6 mL Syringes Recalled Due to Infusion Pump Incompatibility
FDA (Devices) · 2023-11-01
- SevereMonoject 20 mL Syringes Recalled for Infusion Pump Compatibility Issues
FDA (Devices) · 2023-11-01
- CriticalMonoject 35 mL Syringe Recalled for Pump Incompatibility Issues
FDA (Devices) · 2023-11-01
- SevereMonoject 60 mL Syringes Recalled for Infusion Pump Compatibility Issues
FDA (Devices) · 2023-11-01
- SevereMonoject 12 mL Syringes Recalled for Infusion Pump Compatibility Issues
FDA (Devices) · 2023-11-01
- SevereMonoject 1 mL Tuberculin Syringes Recalled for Infusion Pump Compatibility Issues
FDA (Devices) · 2023-11-01