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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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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Cardinal Health Monoject Tuberculin Syringes Recalled for Mislabeling

Agency Publication Date: April 2, 2026
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Summary

Cardinal Health is recalling 198,900 Monoject Tuberculin Syringes (1 mL Luer Lock) because the outer packaging and blister packs are mislabeled. While the labels state they contain Tuberculin syringes, the packages actually contain U-100 Insulin syringes. No incidents or injuries have been reported to date, but using the incorrect syringe type could lead to serious medication dosing errors.

Risk

The syringes inside the packaging are intended for insulin delivery (U-100) rather than tuberculin use, which may lead to healthcare providers administering the wrong dose of medication. This misidentification poses a risk of significant under-dosing or over-dosing of critical medications.

What You Should Do

  1. Identify if you have the recalled product by checking the Catalog Number 1180100777 and Lot Numbers 531164X or 531162X.
  2. Check the packaging for UDI/DI numbers 10884521013414 (individual unit), 20884521013411 (box), or 30884521013418 (case).
  3. Stop using the recalled product immediately.
  4. Contact Cardinal Health or your medical distributor to arrange for the return, replacement, or correction of the affected syringes.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding medical device recalls.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Cardinal Health Monoject Tuberculin Syringe (1 mL Luer Lock)
Model / REF:
1180100777
Lot Numbers:
531164X
531162X
UDI:
10884521013414
20884521013411
30884521013418

Recall Number Z-1768-2026. Distributed worldwide including US and Canada.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98534
Status: Active
Manufacturer: Cardinal Health 200, LLC
Sold By: Authorized medical distributors
Manufactured In: United States
Units Affected: 198,900 units
Distributed To: Nationwide

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.

Find an Attorney

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.