FDA recall Z-3256-2026

Product

REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series

Reason for recall

Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.

Distribution

US Nationwide distribution in the states of LA,MO, MD, TN, UT.

Key facts

Status

Ongoing

Initiation date

2026-08-20

Report date

2026-09-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Powell, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3256-2026