FDA Devices recall · Reported August 12, 2026
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. CARDIAC CATH PACK EAMC1000-05
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 Manifo…
Avid Medical, Inc. recalled Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle M… - a critical-severity action.
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle M… was recalled by Avid Medical, Inc. in August 12, 2026. Reason: Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufa…. Check the official notice for the remedy. Verify recall #Z-2796-2026 with the FDA Devices before acting.
The recall
Avid Medical, Inc. issued this critical-severity FDA Devices recall-Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufa….
- Critical
- severity level
- Class I
- classification
- August 12, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2796-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2796-2026) was formally reported on August 12, 2026, with the manufacturer initiating the action on April 30, 2026. It is classified under Critical severity (Class I), with a current status of Ongoing. Avid Medical, Inc. is listed as the recalling firm, operating out of Toano, VA. Federal records list the affected scope as 5168 kits.
The documented reason for this recall is: 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 h… Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of NC and TX.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. CARDIAC CATH PACK EAMC1000-05
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-2796-2026 |
| Date reported | August 12, 2026 |
| Date initiated | April 30, 2026 |
| Recalling firm | Avid Medical, Inc. |
| Firm location | Toano, VA |
| Affected scope | 5168 kits |
| Distribution | US Nationwide distribution in the states of NC and TX. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2796-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026