FDA-Device2026-04-01Class IPROCESSING DEFECT
Erbe USA Flexible Cryoprobe recalled for rupture risk during surgical use
What this means
Erbe USA Inc. is recalling certain Flexible Cryoprobe surgical devices (model OD 1.7mm, L1.15mm, REF: 20402-410) because the probes may rupture or burst when activated during surgery. This defect could cause injury to patients or surgical staff. No injuries have been reported so far.
- Check if you have any affected cryoprobes by matching the lot numbers to your inventory.
- Stop using any probes from the affected lots immediately.
- Contact Erbe USA Inc. for instructions on returning or replacing the devices.
- Review your surgical schedules and notify patients if their procedures may be affected.
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
5154 units
Manufactured in
2225 Northwest Pkwy SE, Marietta, GA, United States
Products
Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1567-2026Want us to check the next one for you?
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