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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Home Healthcare

Cardinal Health 200, LLC: Monoject Syringes Recalled Due to Pump Compatibility and Brand Removal Issues

Agency Publication Date: February 2, 2024
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Summary

Cardinal Health is recalling 701,678 Monoject enteral and Luer-Lock syringes because certain enteral models are not compatible with feeding pumps, while others are being removed from the market due to manufacturing changes. Using the incompatible enteral syringes with feeding pumps can lead to incorrect dosing or pump errors. Affected products include various sizes of sterile Luer-Lock syringes (1 mL to 60 mL) and purple ENFit enteral syringes (1 mL to 60 mL). Consumers should immediately identify if they have any of the affected lot numbers and contact the manufacturer or their healthcare provider for guidance on next steps.

Risk

The enteral syringes may not be recognized by certain feeding pumps, which can lead to pump failure, delayed feeding, or inaccurate delivery of nutrition. Additionally, manufacturing changes for the Luer-Lock models have prompted a full product removal to ensure patient safety and brand consistency.

What You Should Do

  1. Check your supply for Cardinal Health Monoject Enteral Syringes (purple) or Monoject Luer-Lock Syringes (1 mL, 3 mL, 6 mL, 12 mL, 20 mL, 35 mL, or 60 mL sizes).
  2. Verify the lot numbers on your packaging against the affected list, including enteral lots 230503, 230701, 230501, 230502, 230601, 230602, 230702, and Luer-Lock lots such as 221201, 230201, 230601, and 230701 among others listed on the product labels.
  3. Stop using the purple ENFit enteral syringes with syringe enteral feeding pumps immediately as they may cause pump recognition errors.
  4. Identify the specific REF numbers on the packaging, such as 406SE, 412SE, 435SE, 460SE for enteral syringes, or 1180100777, 1180300777, 1180600777, 1181200777T, 1182000777, 1183500777, and 1186000777T for Luer-Lock syringes.
  5. Contact your healthcare provider or Cardinal Health at 1-800-964-5227 for further instructions on returning the products and obtaining replacements.
  6. Contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this safety notice.

Your Remedy Options

๐Ÿ“‹Other Action

Product removal and warning against use with enteral syringe feeding pumps.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund.

Affected Products

Product: Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System
Model / REF:
REF 406SE
UPC Codes:
26971564466220
16971564466223
06971564466226
Lot Numbers:
230503
230701
Product: Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System
Model / REF:
REF 412SE
UPC Codes:
26971564466237
16971564466230
06971564466233
Lot Numbers:
230501
230502
230601
Product: Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System
Model / REF:
REF 435SE
UPC Codes:
26971564466244
16971564466247
06971564466240
Lot Numbers:
230501
230601
230602
Product: Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection System
Model / REF:
REF 460SE
UPC Codes:
26971564466251
16971564466254
06971564466257
Lot Numbers:
230501
230701
230702
Product: Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack
Model / REF:
REF 1180100777
UPC Codes:
50192253034538
20192253034537
10192253034530
Lot Numbers:
221201
221202
221203
230201
230202
230203
230204
230205
230601
Product: Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack
Model / REF:
REF 1180300777
UPC Codes:
50192253033517
20192253033516
10192253033519
Lot Numbers:
230201
230202
221201
221202
230203
230204
230205
230206
230208
230209
230210
230211
230212
230213
230214
230215
230216
230217
230218
230219
230207
230602
230601
230603
230701
230702
230703
230704
230705
230706
230707
Product: Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack
Model / REF:
REF 1180600777
UPC Codes:
50192253034606
20192253034605
10192253034608
Lot Numbers:
221201
221202
221203
221204
221205
230201
230202
230203
230204
230205
230206
230207
Product: Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack
Model / REF:
REF 1181200777T
UPC Codes:
50192253025819
20192253025818
10192253025811
Lot Numbers:
221101
221102
221103
221104
Product: Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack
Model / REF:
REF 1182000777
UPC Codes:
50192253034675
20192253034674
10192253034677
Lot Numbers:
221201
221202
221203
221204
221205
230201
230202
230203
230204
230205
230206
Product: Cardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack
Model / REF:
REF 1183500777
UPC Codes:
50192253034699
20192253034698
10192253034691
Lot Numbers:
221201
230201
230601
230602
Product: Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack
Model / REF:
REF 1186000777T
UPC Codes:
50192253025833
20192253025832
10192253025835
Lot Numbers:
221101
230601
Product: Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile
Model / REF:
REF 401SE
UPC Codes:
26971564466206
16971564466209
06971564466202
Lot Numbers:
230701
230501
Product: Cardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection Sterile
Model / REF:
REF 403SE
UPC Codes:
26971564466213
16971564466216
06971564466219
Lot Numbers:
230501
230701
230601

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93676
Status: Active
Manufacturer: Cardinal Health 200, LLC
Sold By: medical supply distributors
Manufactured In: United States
Units Affected: 4 products (20186 units; 60760 units; 223056 units; 397676 units)
Distributed To: Nationwide
Agency Last Updated: April 1, 2024

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.