Flexible Cryoprobe — Class I medical device recall Z-1566-2026

Ongoing recall by Erbe USA Inc, reported 2026-04-01, distributed nationwide. Probes may rupture/burst during activation

Recall number	`Z-1566-2026`
Product type	Medical device
Classification	Class I
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Erbe USA Inc, Marietta, GA, United States
Recall initiated	2026-02-12
Classified	2026-03-20
Reported by FDA	2026-04-01
Distributed	Nationwide (US)
Quantity	64,216 units
UPC / GTIN / UDI-DI	`04050147021785`
Lot numbers	`W2459855`, `W2459856`, `W2459857`, `W2462279`, `W2462280`, `W2462281`, `W2462282`, `W2462285`, `W2463589`, `W2463590`, `W2463591`, `W2463592`, `W2463595`, `W2465609`, `W2465755`, `W2468858`, `W2469058`, `W2469059`, `W2469061`, `W2469062`, `W2469080`, `W4465348`, `W4468495`, `WO461310`, `WO461311`, `WO461312`, `WO461314`, `WO461315`, `WO461829`, `WO461831`, `WO461832`, `WO461833`, `WO461834`, `WO461835`, `WO461842`, `WO461843`, `WO461844`, `WO461847`, `WO461848`, `WO462117` and 381 more
Model numbers	`20402-401`

Product

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

Reason for recall

Probes may rupture/burst during activation

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1566-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.