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RecallWatchMedical Device Safety
Class IIOngoingZ-2531-2025

AVID Medical, Inc. recalls Halyard

AVID Medical, Inc.Toano, VA, United StatesReported Sep 17, 2025 · 10 months ago
Legal News Analyst ·

Reason for recall

Potential for open header bag seals, compromising sterility.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit
    UDI 10809160363256.Model Number
    2 affected lots
    16463811/31/2028

What the firm is doing

Owens & Minor notified consignees on about 08/04/2025 via email. Consignees were instructed to discard and discontinue use of all impacted kits. to notify customers if affected units were further distributed, and complete and return the Recall Response Form provided.

DistributionShow details

US Nationwide distribution in the state of Florida.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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