Recall
FDAHealthFebruary 12, 2026

Erbe USA Inc — Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use

⚠️ Probes may rupture/burst during activation

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
February 12, 2026

US Nationwide distribution, including Puerto Rico.

What's affected?

Product
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Lot code
WO472498

Additional details

UDI: 04050147021846/ Expanded Lots:WO472498 WO472499 WO472615 WO472616 WO473794 WO473795 WO474908 WO474909 WO474910 WO475357 WO475358 WO477030 WO477513 WO477514 WO478643 WO478646 WO478647 WO478648 WO478843 WO478844;Initial Lots: WO461840 WO461846 WO462097 W2462284 WO463327 WO463328 WO463388 W2463594 WO464285 WO464286 WO465063 WO465064 W4465351 W2465601 W2465689 W2465749 W2465769 WO467873 WO467874 WO467875 WO468648 WO468649 WO469364 W2459861 W2459862 W2459863

What should I do?

Recommended action

Class I recall. Voluntary: Firm initiated Quantity affected: 3603 units.

View original FDA notice →

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