Recall Z-1768-2026 ยท FMF Syringe, Piston
Cardinal Health 200, LLC
Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777
| Date | Apr 2, 2026 (initiated Feb 27, 2026) |
| Status | Open, Classified |
| Reason | 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 | 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 n |
| Quantity | 198,900 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K851090 | MONOJECT STERILE 1/2 CC & 1CC SYRINGES W & W/O NEE Sherwood Medical Co., Apr 12, 1985 |