ERBE 10402-000Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K190651); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 26, 2026Open, Classified

   A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the return path, leading to excessive pressure causing the cryoprobe to rupture.

   Z-2938-2026 · Root cause: Device Design · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K190651. One submission often covers many models, so check the product and lot details in each record.

• Z-1568-2026 · Feb 12, 2026 · Open, Classified
  Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
• Z-1567-2026 · Feb 12, 2026 · Open, Classified
  Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
• Z-1566-2026 · Feb 12, 2026 · Open, Classified
  Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use