Fresh Recalls

ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: recall status

Notice names this product. Erbe USA’s ERBECRYO 2 Cryosurgical Unit Model/Catalog Number is named in FDA Class II recall Z-2938-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: 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. Identifying details: UDI-DI 04050147013797/ Serial Numbers: All serial numbers up to 11608268 Software Version: 1.0.3. Units affected: 11226 units. Status: Ongoing.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
ERBECRYO 2 Cryosurgical Unit Model/Catalog Number
Company / brand
Erbe USA
Lot / serial / date codes
UDI-DI 04050147013797/ Serial Numbers: All serial numbers up to 11608268 Software Version: 1.0.3
Distribution
US Nationwide distribution including in the states and territories of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Agency product description and boundaries

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

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

Brand
Erbe USA

Recalls naming this model

FDA Class II · Medical device · August 19, 2026

ERBECRYO 2 Cryosurgical Unit Model/Catalog Number recall — Erbe USA Inc

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 r…

Company / brand: Erbe USA

Affected product: ERBECRYO 2 Cryosurgical Unit Model/Catalog Number

Official ID Z-2938-2026 · Official record ↗

See all Erbe USA recalls →

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Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.