Flexible Cryoprobe — Class I medical device recall Z-1568-2026

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

Recall number	`Z-1568-2026`
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	3,603 units
UPC / GTIN / UDI-DI	`04050147021846`
Lot numbers	`W2459861`, `W2459862`, `W2459863`, `W2462284`, `W2463594`, `W2465601`, `W2465689`, `W2465749`, `W2465769`, `W4465351`, `WO461840`, `WO461846`, `WO462097`, `WO463327`, `WO463328`, `WO463388`, `WO464285`, `WO464286`, `WO465063`, `WO465064`, `WO467873`, `WO467874`, `WO467875`, `WO468648`, `WO468649`, `WO469364`, `WO472498`, `WO472499`, `WO472615`, `WO472616`, `WO473794`, `WO473795`, `WO474908`, `WO474909`, `WO474910`, `WO475357`, `WO475358`, `WO477030`, `WO477513`, `WO477514` and 6 more
Model numbers	`20402-411`

Product

Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. 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-1568-2026. 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.