FDA recall Z-2704-2026

Product

Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A

Reason for recall

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

Distribution

Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.

Key facts

Status

Ongoing

Initiation date

2026-06-01

Report date

2026-07-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Athens, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2704-2026