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CLASS I · SeriousFDA

Erbe USA Inc recalls Flexible Cryoprobe

📅 Feb 12, 2026 · 📍 Nationwide
Recalling company
Erbe USA Inc
Product
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Reason
Probes may rupture/burst during activation
Classification
Class I – a reasonable probability that use will cause serious adverse health consequences or death
Recall date
Feb 12, 2026
Reported
Apr 1, 2026
Distribution
US Nationwide distribution, including Puerto Rico.
Status
Ongoing
Quantity
3603 units
Lot / codes
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
Company location
Marietta, GA
Recall type
Voluntary: Firm initiated
Recall number
Z-1568-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1568-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.