Monoject Syringe Recall

Health Canada Recalls & Safety Alerts

Published March 13th, 2026

Detected March 13th, 2026

Summary

Health Canada has issued a Type II recall for Monoject 1mL Luer Lock Syringes due to incorrect labeling. The affected products are mislabeled as Tuberculin syringes but contain U-100 Insulin syringes. Healthcare providers are advised to contact the manufacturer for more information.

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What changed

Health Canada has issued a Type II recall for specific lots of Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile (Model 1180100777, Lot numbers 531164X and 531162X). The issue stems from incorrect labeling where the outer packaging and blister pack 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 risk of incorrect dosage administration.

Healthcare providers who may have received these affected products are instructed to contact the manufacturer, Cardinal Health, for additional information. While no specific compliance deadline is mentioned, the nature of a product recall necessitates prompt action to identify and segregate affected inventory to prevent patient harm. Failure to address such recalls can lead to patient safety incidents and potential regulatory scrutiny.

What to do next

Identify and segregate affected Monoject 1mL Luer Lock Syringes (Model 1180100777, Lot numbers 531164X and 531162X).
Contact Cardinal Health for additional information regarding the recall.

Source document (simplified)

Health product recall

Monoject™ 1mL Luer Lock Syringe, Tuberculin Print, Sterile (French translation pending)

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