FDA-Device2026-04-01Class IPROCESSING DEFECT
Erbe USA Flexible Cryoprobe recalled for rupture risk during surgical activation
What this means
Erbe USA Inc is recalling specific lots of Flexible Cryoprobe devices used in surgery because the probes may rupture or burst when activated. This defect could affect patient safety during the procedure. No injuries have been reported to date.
- Immediately stop using affected Flexible Cryoprobe devices (REF 20402-411) with the listed lot numbers
- Check your facility's inventory against the lot numbers provided
- Contact your Erbe USA Inc representative or the FDA for instructions on device return or replacement
- Review patient records for devices from affected lots already used
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
2408 units
Manufactured in
2225 Northwest Pkwy SE, Marietta, GA, United States
Products
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1568-2026Want us to check the next one for you?
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