Boston Scientific Corporation: Syringe, Irrigating (non Dental)
Recall Summary Boston Scientific is recalling Rapid Refill Continuous Injection System syringes nationwide because they contain a defective syringe component that may loosen or disconnect from the manifold during use. This could result in fluid leaks, inability to inject or withdraw fluid properly, or complete separation of the syringe from the system, potentially requiring the device to be replaced mid-procedure. The recall affects syringes distributed across all U.S. states.
- Recalling firm
- Boston Scientific Corporation
- Product
- Rapid Refill Continuous Injection System, UPN M00566001
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-30
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution. OUS consignee list pending.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/be940c57-3c3b-4e65-a77c-11f1c4c03b49