FDA recall Z-1566-2026

Product

Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILEEO. For surgical use

Reason for recall

Probes may rupture/burst during activation

Distribution

US Nationwide distribution, including Puerto Rico.

Key facts

Status

Ongoing

Initiation date

2026-02-12

Report date

2026-04-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Marietta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1566-2026