← FDA ENFORCEMENT
Z-1568-2026Class I

Erbe USA Inc

Recalling firm
Erbe USA Inc
Product type
Device
Status
Ongoing
Report date
2026-04-01
Distribution
US Nationwide distribution, including Puerto Rico.
Firm state
GA
Product quantity
3603 units
Initiated by
Voluntary: Firm initiated
Reason for recall

Probes may rupture/burst during activation

Product description

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

Code / lot info

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

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.