FDA recall Z-1567-2026
Erbe USA Inc · Class I · device
Product
Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. 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-1567-2026