Recall Z-2725-2026 ยท KYZ Syringe, Irrigating (Non Dental)
Boston Scientific Corporation
Rapid Refill Continuous Injection System, UPN M00566001
| Date | Jul 10, 2026 (initiated Jun 30, 2026) |
| Status | Open, Classified |
| Reason | Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure. |
| Root cause | Under Investigation by firm |
| Action | On June 30, 2026, the firm began notifying US customers via letters titled "Urgent Medical Device Removal - Immediate Action Required." Customers were instructed to immediately stop further use or distribution of affected product, and segregate it. Continue to follow the standard care when monitoring patients treated with the contact. Product is to be returned to Boston Scientific. |
| Quantity | 153,921 (US); 119,274 (OUS) |
| Distribution | US Nationwide distribution. OUS consignee list pending. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.