CLASS I ONGOING Device recall · Reported 20 May 2026 · FDA Enforcement Report
Custom Convenience Kit containing Medline Namic recalled
Windstone Medical Packaging is recalling Custom Convenience Kit containing Medline Namic Angiographic Control Syringes with, distributed nationwide in the US. The recall was initiated on 2 Apr 2026 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2066-2026
- FDA event ID
- 98741
- Recalling firm
- Windstone Medical Packaging, Billings, MT
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 2 Apr 2026
- FDA classified
- 8 May 2026
- Reported
- 20 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Syringes & Needles
Timeline
| 2 Apr 2026 | Recall initiated by company | |
| 8 May 2026 | Classified by FDA | +36 days |
| 20 May 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between syringe and manifold. If unwinding occurs, there is a potential for biohazard exposure, blood loss, infection. or air embolism.
Product as listed by the FDA
Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908F
Where it was distributed
US Nationwide distribution in the state of Arizona.
Questions about this recall
Why was it recalled?
Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between syringe and manifold. If unwinding occurs, there is a potential for biohazard exposure, blood loss, infection. or air embolism.
Which lots are affected?
Pack AMS6908E UDI-DI B098AMS6908E0 Lot 214875 Pack AMS6908F UDI-DI B098AMS6908F0 Lots 215436, 225001, 226706, 234088
Where was it sold?
US Nationwide distribution in the state of Arizona.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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