HIGHFDA DEVICE

Rapid Refill Continuous Injection System, UPN M00566001

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.

Boston ScientificHealth & Personal CareMedical DevicesUDI-DI (GTIN) 08714729285151 Lots 337866113382594933826026

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
June 30, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
June 30, 2026
Hazard Level
HIGH
Brand
Boston Scientific
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Boston Scientific
Model numbers
UDI-DI (GTIN) 08714729285151 Lots 33786611, 33825949, 33826026, 33949916, 33968571, 33968575, 34079981, 34153104 +12 more
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    June 30, 2026

  2. Reported by FDA DEVICE

    July 22, 2026

  3. RecallRadar source check

    July 28, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Corporation or your healthcare provider for instructions. Notification method: Letter

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Full Description

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 II. Quantity: 153,921 (US); 119,274 (OUS). Distribution: US Nationwide distribution. OUS consignee list pending.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
UDI-DI (GTIN) 08714729285151 Lots 33786611
33825949
33826026
33949916
33968571
+15 more
Affected States
ALL
Report Date
July 22, 2026
Recall Status
ACTIVE

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