Z-1768-2026Class II

Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777

Name: Z-1768-2026 Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777
Creator: Cardinal Health 200, LLC
Published: 2026-02-27
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2026-02-27 / Open, Classified / root cause: labeling and UDI

FDA source

Cardinal Health 200, LLC began a recall of Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777 on 2026-02-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1768-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-27
Posted: 2026-04-02
Recalling firm: Medtronic, Inc.
Product: Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777
Product code: FMF Syringe, Piston
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 198,900 units
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: UDI/DI 10884521013414 (each), 20884521013411 (box), 30884521013418 (case), Lot Numbers: 531164X, 531162X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1768-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1768-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02

Product code FMF

K851090Class IIMonoject Sterile 1/2 Cc & 1Cc Syringes W & W/o NeeSherwood Medical Co. / cleared 1985-04-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)