FDA-Device2026-04-01Class IPROCESSING DEFECT
Erbe USA flexible cryoprobe recalled for rupture hazard during surgical use
What this means
Erbe USA has recalled certain flexible cryoprobes used in surgery because they may rupture or burst when activated. The defect could cause unexpected device failure during a procedure. No injuries have been reported, but the risk requires immediate action.
- Check your lot number against the FDA list—if it matches, stop using the device
- Contact Erbe USA or your supplier immediately for instructions on device removal and replacement
- Notify your surgical team and facility of this recall
The agency's original wording
Hazard
Probes may rupture/burst during activation
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution, including Puerto Rico.
Affected count
33390 units
Manufactured in
2225 Northwest Pkwy SE, Marietta, GA, United States
Products
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILEEO. For surgical use
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1566-2026Want us to check the next one for you?
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