FDA recall Z-1975-2026

Product

Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.

Reason for recall

Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

Distribution

US distribution to FL, IL, MO, MS, NC, NE, TX.

Key facts

Status

Ongoing

Initiation date

2026-03-13

Report date

2026-05-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Toano, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1975-2026