FDA recall Z-2964-2026

Product

Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).

Reason for recall

The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.

Distribution

US Nationwide distribution in the state of TX.

Key facts

Status

Ongoing

Initiation date

2026-07-10

Report date

2026-08-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Toano, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2964-2026