Monoject recallZ-1768-2026 · Cardinal Health 200, LLC · initiated Feb 27, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cardinal Health 200, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
Cardinal Health issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 2/27/2026 via overnight mail. The notice explained the issue, potential risk to health and requested the following: "Actions Required: 1. REVIEW your inventory for the affected product codes. Location of product code and lot are shown on the label. 2. COMMUNICATE with all personnel that utilize the affected product. 3. SEGREGATE and quarantine all affected product upon review of your inventory. Affected product should not be used. Utilize return directions below to return product. 4. DISSEMINATE this notice to all departments, clinics and external campuses that handle the affected products. 5. DISTRIBUTORS please notify any customers to whom you may have distributed/forwarded affected product to about this medical device recall and share a copy of this notice. 6. RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to [email protected], whether you have affected product or not." For questions related to this notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: [email protected] or call 800-292-9332.
Recall details
- Recall number
- Z-1768-2026
- Status
- Open, Classified
- Initiated by the company
- Feb 27, 2026
- Posted by the FDA
- Apr 2, 2026
- Recalling firm
- Cardinal Health 200, LLC
- Quantity
- 198,900 units
- Product code
- FMF
- FDA submissions
- K851090
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
Product description
Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777
Code information (models, lots, serial numbers)
UDI/DI 10884521013414 (each), 20884521013411 (box), 30884521013418 (case), Lot Numbers: 531164X, 531162X
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Monoject 1180100777Cardinal Health, Inc. · Syringe, piston1 recall1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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