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

Medical DevicesSource: FDA (device) · Date: 2026-04-01

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Erbe USA Inc
Product
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Reason / hazard
Probes may rupture/burst during activation
Classification
Class I
Status
Ongoing
Distribution / sold at
US Nationwide distribution, including Puerto Rico.
Recall initiated
2026-02-12
Code 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
Product quantity
3603 units
Voluntary mandated
Voluntary: Firm initiated
City
Marietta
State
GA
Country
United States
Event id
98429
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