medical MODERATE Updated 2026-08-19

Erbe USA Inc recalls ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-00

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Recalled Product

ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000

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Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI 04050147013797/ Serial Numbers: All serial numbers up to 11608268 Software Version: 1.0.3

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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View official government recall

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