FDA recall Z-1568-2026
Erbe USA Inc · Class I · device
Product
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. 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-1568-2026