Recall Z-1566-2026 ยท GEH Unit, Cryosurgical, Accessories
Erbe USA Inc
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use
| Date | Mar 20, 2026 (initiated Feb 12, 2026) |
| Status | Open, Classified |
| Reason | Probes may rupture/burst during activation |
| Root cause | Process control |
| Action | On May 5, 2026, ERBE USA issued a "Urgent Medical Device Recall Expansion notification via E-Mail. The expansion was issued due to new lot numbers that may cause the same failure mode. The original notification was issued on Feb. 12, 2026. ERBE asked consignees to take the following actions: 1. Discontinue use of the products with the affected lot numbers. 2. Examine your inventory, remove, and quarantine any identified devices with the affected lot numbers 3. Ensure all applicable personnel within the vicinity of device activation carefully read the content of this notification. If affected |
| Quantity | 64216 units |
| Distribution | US Nationwide distribution, including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190651 | ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprob Erbe Elektromedizin GmbH, Jan 7, 2020 |