Monoject 35 mL Syringe Recalled for Pump Incompatibility Issues
Cardinal Health is recalling 1,097,048 Monoject 35 mL syringes due to demonstrated compatibility and recognition issues with infusion pumps. The affected units were distributed nationwide.
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 reasonable probability of serious health consequences. Per the rubric, FDA Class I recalls receive a Critical severity rating regardless of whether harm has been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling Monoject 35 mL Syringe Luer-Lock Tip Soft Pack due to demonstrated recognition and compatibility issues with syringe infusion pumps. The recalled syringes have lot numbers 221201, 230201, 230601, and 230602. Approximately 1,097,048 units were distributed nationwide to medical facilities across all U.S. states and territories.
The FDA classified this recall as Class I because infusion pumps may fail to properly recognize the syringes or may not be fully compatible with them, potentially resulting in device malfunction or medication delivery errors.
Patients and healthcare providers using affected syringes should stop use and contact their supplier or Cardinal Health for replacement. Affected syringes can be identified by lot numbers 221201, 230201, 230601, and 230602, or by their UDI/DI codes (10192253034691 for each unit, 20192253034698 for box, 50192253034699 for case).
The recalled product
- Product
- Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 1,097,048
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 (8)
- Product Code: 1183500777
- UDI/DI: 10192253034691 - each
- 20192253034698 - box
- 50192253034699 - case
- Lot Numbers: 221201
- 230201
- 230601
- 230602
Distribution
Part of a larger recall action
This product is one of 6 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 6 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 · pump incompatibility
See all →- SevereMonoject 1 mL Tuberculin Syringes Recalled for Infusion Pump Compatibility Issues
FDA (Devices) · 2023-11-01
- SevereMonoject 20 mL Syringes Recalled for Infusion Pump Compatibility Issues
FDA (Devices) · 2023-11-01
- SevereMonoject 6 mL Syringes Recalled Due to Infusion Pump Incompatibility
FDA (Devices) · 2023-11-01
Similar recalls
- SevereCardinal Health Monoject sterile syringes recalled due to manufacturing changes
FDA (Devices) · 2024-02-14
- SevereCardinal Health Monoject Sterile Syringes Recalled for Manufacturing Change
FDA (Devices) · 2024-02-14
- HighMonoject tuberculin syringes incompatible with certain IV connectors
FDA (Devices) · 2023-10-25
- SevereCardinal Health Monoject Syringes Recalled Due to Manufacturing Changes
FDA (Devices) · 2024-02-14
- SevereCardinal Health Monoject Enteral Syringes Recalled for Pump Incompatibility
FDA (Devices) · 2024-02-14
- CriticalMonoject Insulin Syringes Recalled for Incompatibility with Needleless IV Connectors
FDA (Devices) · 2024-11-20