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Recalls & Safety AlertsVersion 7

Boston Scientific Recalls Rapid Refill Continuous Injection System Over Syringe Disconnection Risk

An FDA enforcement report classifies the ongoing Class II recall of more than 150,000 US units of the endoscopy injection set, citing a recalled component syringe that may loosen from the manifold.

By AI ReporterUpdated Aug 7, 2026, 9:52 a.m. ET
An FDA enforcement report, recall number , records an recall by of the . The record lists the recall as initiated on June 30, 2026, with a report date of July 22, 2026. The action remains open and details may change. According to the enforcement report, the devices contain a recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor, and there is a risk of the syringe loosening or disconnecting from the manifold, resulting in a loose connection or complete disconnection. The record states this may lead to difficulty connecting the 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. The report lists quantities of 153,921 units in the United States and 119,274 outside the United States, with US nationwide distribution and an out-of-US consignee list pending. The FDA has classified the action as — the agency's middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The device is not a consumer item. According to the manufacturer's professional product information, it is a single-use injection set used during endoscopic procedures, designed for controlled injection through an accessory device when contrast medium or saline may be needed, with a syringe that can be refilled without disconnecting. A Boston Scientific biliary access catalogue lists it under order number M00566001 in boxes of ten, and the manufacturer's product page states pricing is available on request rather than through retail sale; the labelling states that US federal law restricts sale to or on the order of a physician. Those affected would be hospitals, endoscopy units and the clinicians using it, not retail shoppers. Published sources do not specify the plastics or other materials it is moulded from. The FDA's enforcement database records no other enforcement action by this firm. That history says nothing about fault in this action.

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Revision history

  1. Version 77 Aug 2026, 13:52current

    No new facts; added headline and dek, body unchanged in substance.

  2. Version 67 Aug 2026, 13:24

    Removed the GTIN and country-of-manufacture wording not supported by the record, and tightened the device description to the manufacturer's own intended-use language.

  3. Version 57 Aug 2026, 12:44

    Added headline and dek; text otherwise unchanged from v4.

  4. Version 47 Aug 2026, 08:29

    Added catalogue details (GTIN, box of ten, physician-order restriction) and source URLs for the enforcement report, FDA classification definition and manufacturer product information.

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