AVID Medical, Inc.: Medical Device Recall in 2025 - (Recall #: Z-2531-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit.

Product Classification:

Class II

Date Initiated: August 4, 2025

Date Posted: September 17, 2025

Recall Number: Z-2531-2025

Event ID: 97452

Reason for Recall:

Potential for open header bag seals, compromising sterility.

Status: Ongoing

Product Quantity: 228 units

Code Information:

Model Number: 1646381. UDI: 10809160363256. Lot Number: 1646381. Expiration Date: 1/31/2028.

Distribution Pattern:

US Nationwide distribution in the state of Florida.

Voluntary or Mandated:

Voluntary: Firm initiated