Recall Z-2938-2026— Erbe USA Inc

Name: FDA recall Z-2938-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-26

Class II · Ongoing

Class II FDA medical device recall by Erbe USA Inc, initiated 2026-06-26. It names one FDA 510(k) clearance: K190651. Product: ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000. Reason: 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..

Recalling firm: Erbe USA Inc
Classification: Class II
Status: Ongoing
Initiated: 2026-06-26
Firm location: Marietta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K190651 — ERBECRYO 2 Cryosurgical Unit +4 moreErbe Elektromedizin GmbH·cleared 2020-01-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.