Class IOngoingZ-1566-2026
Erbe USA Inc recalls Flexible Cryoprobe (OD 1.1mm
Probes may rupture/burst during activation
- Accessories Cryosurgical Unit
- Process control
Erbe USA IncGAApr 1, 2026
Accessories Cryosurgical Unit recalls
The FDA has posted 11 enforcement recalls of accessories cryosurgical unit devices since 2025, including 3 Class I (most serious) recalls. Most recent report: Apr 1, 2026.
Class I: 3Class II: 8
Who is recalling these devices
Latest recalls
View all 11 in the recall browser →Class IOngoingZ-1568-2026
Erbe USA Inc recalls Flexible Cryoprobe (OD 2.4mm
Probes may rupture/burst during activation
- Accessories Cryosurgical Unit
- Process control
Erbe USA IncGAApr 1, 2026
Class IOngoingZ-1567-2026
Erbe USA Inc recalls Flexible Cryoprobe (OD 1.7mm
Probes may rupture/burst during activation
- Accessories Cryosurgical Unit
- Process control
Erbe USA IncGAApr 1, 2026
Class IIOngoingZ-2550-2025
Boston Scientific Corporation recalls ICEfx Cryoablation System
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
- Accessories Cryosurgical Unit
- Process control
Boston Scientific Corp…MNSep 17, 2025
Class IIOngoingZ-2551-2025
Boston Scientific Corporation recalls Preventive Maintenance (PM) Kit ICEFX
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
- Accessories Cryosurgical Unit
- Process control
Boston Scientific Corp…MNSep 17, 2025
Class IIOngoingZ-1687-2025
Boston Scientific Corporation recalls IceSeed 1.5 CX S NEEDLE OUS
Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing).…
- Accessories Cryosurgical Unit
- Process control
Boston Scientific Corp…MNMay 7, 2025
Class IIOngoingZ-1689-2025
Boston Scientific Corporation recalls IceSeed 1.5 CX NEEDLE OUS
Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing).…
- Accessories Cryosurgical Unit
- Process control
Boston Scientific Corp…MNMay 7, 2025
Class IIOngoingZ-1686-2025
Boston Scientific Corporation recalls IceSeed 1.5 CX S NEEDLE US
Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing).…
- Accessories Cryosurgical Unit
- Process control
Boston Scientific Corp…MNMay 7, 2025
Class IIOngoingZ-1688-2025
Boston Scientific Corporation recalls IceSeed 1.5 CX NEEDLE US
Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing).…
- Accessories Cryosurgical Unit
- Process control
Boston Scientific Corp…MNMay 7, 2025
Class IIOngoingZ-1104-2025
New Medical Technologies Gmbh recalls Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each)
During the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting in partial or complete emptying of the cartridge before its intended use.
- Accessories Cryosurgical Unit
- Device Design
New Medical Technologi…Feb 12, 2025
Class IIOngoingZ-1103-2025
New Medical Technologies Gmbh recalls Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each)
During the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting in partial or complete emptying of the cartridge before its intended use.
- Accessories Cryosurgical Unit
- Device Design
New Medical Technologi…Feb 12, 2025
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Unit, Cryosurgical, Accessories”). Informational only — verify against the FDA before acting.