Boston Scientific Rapid Refill Continuous Injection System Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Boston Scientific Corporation is recalling its Rapid Refill Continuous Injection System due to a risk of syringe loosening or disconnection from the manifold.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 10, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
What Happened
Boston Scientific Corporation initiated a voluntary recall of the Rapid Refill Continuous Injection System after determining that the devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, which may result in loose connection or complete disconnection.
Which Products Are Affected
The recall affects the Rapid Refill Continuous Injection System, UPN M00566001, distributed nationwide in the United States (153,921 units) and outside the United States (119,274 units). Affected lots are identified by UDI-DI (GTIN) 08714729285151 and include numerous lot numbers listed in FDA recall Z-2725-2026. The recall is classified as Class II.
What You Should Do
Consumers and healthcare providers should contact Boston Scientific Corporation for further information regarding the recall.
Why This Matters
The potential disconnection 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.
Source
FDA Enforcement Report, recall number Z-2725-2026, report date 20260722.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,263 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 10, 2026.
Frequently Asked Questions
Common questions about this FDA recall.