Erbe USA Inc: Unit, Cryosurgical, Accessories

Recall Summary Erbe USA Inc is recalling Flexible Cryoprobes (model 20402-401) used in surgical procedures because the probes may rupture or burst when activated. The affected probes have been distributed nationwide across all U.S. states and Puerto Rico.

Recalling firm
Erbe USA Inc
Product
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILEEO. For surgical use
Reason
Probes may rupture/burst during activation
Classification
Class II
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-02-12
Status
Open, Classified
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
US Nationwide distribution, including Puerto Rico.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/5e34a443-8177-4360-a0ec-d60650fc6305