FDA Recall of Flexible Cryoprobe by Erbe USA Inc
Erbe USA Inc is recalling 2408 units of Flexible Cryoprobe due to potential rupture during activation, affecting devices distributed nationwide in the United States and Puerto Rico.
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, which could pose risks during surgical use.
Which Products Are Affected
The affected product is the Flexible Cryoprobe (OD 2.4mm, L1.15mm) with reference number REF: 20402-411. A total of 2408 units are involved, distributed US nationwide, including Puerto Rico. The recall includes UDI: 04050147021846 and specific 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, and W2459863. The official recall number is Z-1568-2026.
What You Should Do
Consumers should stop using the affected Flexible Cryoprobe and contact Erbe USA Inc for further instructions, as the recall was initiated voluntarily by the firm with initial notification via email.
Why This Matters
This recall involves medical devices used in surgery, and the potential for probes to rupture could impact patient safety during procedures. It affects a significant number of units distributed across the United States.
Source
FDA recall information for event ID 98429, available via the FDA website under recall number Z-1568-2026.
Source: FDA Official Notice