Monoject Syringe Recall - Incorrect Insulin Labeling

Health Canada Recalls & Safety Alerts

Published March 13th, 2026

Detected March 14th, 2026

Summary

Health Canada has issued a recall for Monoject 1mL Luer Lock Syringes due to incorrect insulin labeling. The outer packaging indicates a tuberculin syringe, but the syringes inside are U-100 insulin syringes. Healthcare providers are advised to contact the manufacturer for more information.

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What changed

Health Canada has announced a Type II recall for specific lots of Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile (Model 1180100777). The issue stems from a discrepancy where the outer packaging and blister pack labeling identify the product as a 1mL Luer Lock Tuberculin Syringe, but the syringes contained within are actually U-100 Insulin syringes. This mislabeling poses a significant risk of incorrect insulin dosage administration.

Healthcare providers who may have received these affected products are instructed to contact Cardinal Health 200, Llc for additional information. While no specific compliance deadline or penalty is mentioned, the immediate action required is to identify and segregate affected products to prevent their use and potential patient harm. This recall highlights the critical importance of verifying product labeling against contents, especially for critical drug delivery devices like insulin syringes.

What to do next

Identify and segregate affected Monoject syringes (Lot numbers 531164X, 531162X).
Contact Cardinal Health 200, Llc for additional information regarding the recall.
Prevent the use of mislabeled syringes to avoid incorrect insulin dosage.

Source document (simplified)

Health product recall

Monoject™ 1mL Luer Lock Syringe, Tuberculin Print, Sterile

Brand(s)

Cardinal Health 200, Llc Also Trading As Cardinal Health

Last updated

2026-03-13

Summary

Product Monoject™ 1mL Luer Lock Syringe, Tuberculin Print, Sterile Issue Medical devices - Labelling and packaging What to do Contact the manufacturer if you require additional information.

Audience Healthcare

Affected products

| Affected products | Lot or serial number | Model or catalogue number |
| --- | --- | --- |
| Monoject™ 1mL Luer Lock Syringe, Tuberculin Print, Sterile | 531164X | 1180100777 |
| Monoject™ 1mL Luer Lock Syringe, Tuberculin Print, Sterile | 531162X | 1180100777 |

Issue

The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however, the syringes contained within the packages are U-100 Insulin syringes.

Additional information

Details

Original published date:

2026-03-13

Alert / recall type Health product recall Category Health products - Medical devices - General hospital and personal use Companies Cardinal Health 200, Llc Also Trading As Cardinal Health

3651 Birchwood Drive, Waukegan, Illinois, United States, 60085

Published by Health Canada Audience Healthcare Recall class Type II Recall date

2026-03-02

Identification number RA-81734