Recall Z-1566-2026— Erbe USA Inc

Name: FDA recall Z-1566-2026
Creator: U.S. Food and Drug Administration
Published: 2026-02-12

Class I · Ongoing

Class I FDA medical device recall by Erbe USA Inc, initiated 2026-02-12. It names one FDA 510(k) clearance: K190651. Product: Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILEEO. For surgical use. Reason: Probes may rupture/burst during activation.

Recalling firm: Erbe USA Inc
Classification: Class I
Status: Ongoing
Initiated: 2026-02-12
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

Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILEEO. For surgical use

Reason for recall

Probes may rupture/burst during activation

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