FDA Recall of Flexible Cryoprobe by Erbe USA Inc
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
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 recall 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 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 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.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
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 (1,333 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to April 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.