Recall of Flexible Cryoprobe by Erbe USA Inc
Erbe USA Inc is recalling 33,390 units of Flexible Cryoprobe due to potential rupture during activation, affecting US nationwide distribution.
What this fda recalls alert tells you, and what most readers miss
This notice was issued by FDA on April 8, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
Most readers skim an alert like this, check whether they are personally affected, and move on. The more useful lens is to read the alert as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar alerts have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized fda recalls advisory is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
Erbe USA Inc is recalling the Flexible Cryoprobe because the probes may rupture or burst during activation, as classified by the FDA as a Class I recall.
Which Products Are Affected
The affected product is the Flexible Cryoprobe (OD 1.1mm, L1.15mm) with oversheath (OD2.6mm, L817mm), REF: 20402-401, STERILE EO, for surgical use. A total of 33,390 units are involved, distributed US nationwide including Puerto Rico. The specific lots affected include: WO461310, WO461311, WO461312, WO461314, WO461315, WO461829, WO461831, WO461832, WO461833, WO461834, WO461835, WO461842, WO461843, WO461844, WO461847, WO461848, WO462117, WO462118, WO462119, WO462120, WO462121, WO462122, WO462123, WO462124, WO462125, WO462128, WO462129, WO462130, WO462373, WO462374, WO462375, WO462376, WO462377, WO462378, WO462379, WO462380, WO462387, WO462388, WO462389, WO462397, WO462825, WO462826, WO462827, WO462828, WO462829, WO462830, WO462831, WO462838, WO462839, WO462840, WO462841, WO462842, WO462843, WO462844, WO462845, WO462846, WO462847, WO462848, WO462849, WO463308, WO463309, WO463310, WO463311, WO463312, WO463313, WO463314, WO463316, WO463317, WO463390, WO463391, WO463392, WO463393, WO463394, WO463395, WO463396, WO463397, WO463398, WO463399, WO463400, WO463401, WO463402, WO463403, WO463404, WO463405, WO463406, WO463407, WO463408, WO463409, WO464270, WO464271, WO464272, WO464273, WO464274, WO464275, WO464276, WO464277, WO464278, WO464279, WO464699, WO464700, WO464701, WO464702, WO464703, WO464994, WO464995, WO464996, WO464997, WO465021, WO465022, WO465023, WO465024, WO465025, WO465026, WO465027, WO465050, WO465051, WO465052, WO465053, WO465054, WO465055, WO465056, WO465057, WO465066, WO465067, WO465068, WO465069, WO465243, WO465244, WO465245, WO465246, WO465247, WO465248, WO465249, WO465255, WO465256, WO465257, WO465258, WO465259, WO465260, WO465261, WO465262, WO465266, WO465267, WO465268, WO465269, WO467858, WO467859, WO467860, WO467861, WO467862, WO467863, WO467884, WO467885, WO467886, WO468210, WO468211, WO468212, WO468213, WO468214, WO468215, WO468216, WO468217, WO468218, WO468219, WO468220, WO468221, WO468230, WO468231, WO468232, WO468609, WO468610, WO468611, WO468612, WO468613, WO468614, WO468618, WO468619, WO468620, WO468621, WO468622, WO468623, WO468624, WO468625, WO468626, WO468627, WO468628, WO468629, WO468630, WO468631, WO468632, WO468634, WO468635, WO468636, WO468637, WO468638, WO468639, WO468640, WO468641, WO468654, WO468655, WO468656, WO468657, WO468658, WO468659, WO468660, WO468661, WO468662, WO468663, WO468664, WO468665, WO468666, WO468669, WO468670, WO469350, WO469351, WO469352, WO469353, WO469354, WO469357, WO469358, WO469359, WO471335, WO471336, WO471337, WO471338, WO471339, WO471340, WO471341, WO471342, WO471344, W4468495, W4465348, W2469080, W2469062, W2469061, W2469059, W2469058, W2468858, W2465755, W2465609, W2463595, W2463592, W2463591, W2463590, W2463589, W2462285, W2462282, W2462281, W2462280, and W2462279. The recall initiation date was February 12, 2026, with official recall number Z-1566-2026.
What You Should Do
Affected users should follow the initial firm notification via email and contact Erbe USA Inc for further instructions regarding this voluntary recall.
Why This Matters
This Class I recall highlights a serious potential risk from device failure during surgical procedures, which could lead to adverse health consequences for patients.
Source
This recall is attributed to the FDA. For more information, refer to the FDA's medical device recalls page at https://www.fda.gov/medical-devices/medical-device-recalls/ and search for recall number Z-1566-2026.
Source: FDA Official Notice