FDA Class I Recall for Erbe USA Inc's Flexible Cryoprobe
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Erbe USA Inc is recalling 5154 units of Flexible Cryoprobe devices due to potential rupture during activation, classified as a Class I recall by the FDA.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 9, 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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Erbe USA Inc is recalling Flexible Cryoprobe devices because the probes may rupture or burst during activation, posing a serious risk.
Which Products Are Affected
The affected product is the Flexible Cryoprobe (OD 1.7mm, L1.15mm) with REF: 20402-410, intended for surgical use. A total of 5154 units are involved, distributed nationwide in the United States, including Puerto Rico. The specific codes include UDI: 04050147021822 and lots: WO459860, WO462187, WO462322, WO462390, WO462391, WO462392, WO462393, WO462396, WO462677, WO462678, WO463323, WO463324, WO463325, WO463326, WO463386, WO463387, WO464280, WO464281, WO464282, WO464283, WO464284, WO465059, WO465060, WO465061, WO465062, WO467876, WO467877, WO467878, WO467879, WO468225, WO468226, WO468227, WO468642, WO468643, WO468644, WO468645, WO468647, WO468671, WO468672, WO468673, WO468674, WO469361, WO469362, WO469363, W2459858, W2459958, W2462283, W2463593, W2465596, W2465623, W2465693, W2465768, W2468859, W2470050, W2470051, W2470052, and W4465597. The recall number is Z-1567-2026.
What You Should Do
Consumers should contact Erbe USA Inc for instructions, as the recall was initiated via e-mail notification. Stop using the affected devices and follow the firm's guidance for returns or refunds.
Why This Matters
This Class I recall indicates a reasonable probability of serious adverse health consequences from the product defect. It affects medical devices used in surgery, highlighting potential risks in healthcare settings.
Source
Information from the FDA recall notice, recall number Z-1567-2026. For details, visit the FDA website or search for event ID 98429.
Original source: FDA Official Notice ↗
Related FDA Recalls
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Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,666 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to April 9, 2026.
Frequently Asked Questions
Common questions about this FDA recall.