Flexible Cryoprobe — Class I medical device recall Z-1567-2026

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

Recall number	`Z-1567-2026`
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	8,284 units
UPC / GTIN / UDI-DI	`04050147021822`
Lot numbers	`W2459858`, `W2459958`, `W2462283`, `W2463593`, `W2465596`, `W2465623`, `W2465693`, `W2465768`, `W2468859`, `W2470050`, `W2470051`, `W2470052`, `W4465597`, `WO459860`, `WO462187`, `WO462322`, `WO462390`, `WO462391`, `WO462392`, `WO462393`, `WO462396`, `WO462677`, `WO462678`, `WO463323`, `WO463324`, `WO463325`, `WO463326`, `WO463386`, `WO463387`, `WO464280`, `WO464281`, `WO464282`, `WO464283`, `WO464284`, `WO465059`, `WO465060`, `WO465061`, `WO465062`, `WO467876`, `WO467877` and 53 more
Model numbers	`20402-410`

Product

Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. 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-1567-2026. 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.