CLASS I ONGOING Device recall · Reported 12 Aug 2026 · FDA Enforcement Report
Halyard convenience kits containing Medline Namic recalled
Avid Medical is recalling Halyard convenience kits containing Medline Namic Angiographic Star Off Handle Manifolds, distributed nationwide in the US. The recall was initiated on 30 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-2796-2026
- FDA event ID
- 99339
- Recalling firm
- Avid Medical, Toano, VA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 30 Apr 2026
- FDA classified
- 31 Jul 2026
- Reported
- 12 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Particulate Matter
- Device type
- Other Medical Devices
Timeline
| 30 Apr 2026 | Recall initiated by company | |
| 31 Jul 2026 | Classified by FDA | +92 days |
| 12 Aug 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 Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.
Product as listed by the FDA
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. CARDIAC CATH PACK EAMC1000-05
Where it was distributed
US Nationwide distribution in the states of NC and TX.
Questions about this recall
Why was it recalled?
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.
Which lots are affected?
UDI-DI 10809160377314 Lots 1573593 1583827 1609541 1612134 1612516 1619132 1623384 1627013 1635459 1672306 1675159
Where was it sold?
US Nationwide distribution in the states of NC and TX.
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.
Other products in this recall event
2 other products · FDA event 99339This product is part of a recall event; the main page for the event is Halyard convenience kits containing Medline Namic recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Halyard convenience kits containing Medline Namic recalled | Avid Medical | Particulate Matter | Nationwide | |
| CLASS I | Halyard convenience kits containing Medline Namic recalled | Avid Medical | Particulate Matter | Nationwide |
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