--- title: "HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of stricture... — FDA record Z-0325-2022 | Is It on Recall" description: "Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure" url: https://isitonrecall.com/recall/fda-device-z-0325-2022-hurricane-rx-dilation-balloon-8mm-4cm-for-endoscopic-dilatation-of-strictures-of-the-biliary-tree-an/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter ... — FDA record Z-0325-2022 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Oct 21, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545940 - **Reason**: Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure - **Classification**: Class II - **Recalling firm**: Boston Scientific Corporation - **Quantity**: Not supplied - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0325-2022 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0325-2022%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | Batches: 25608760, 25612672, 25649815, 25649818, 25649822, 25649823, 25649827, 25649828, 25649832, 25649833, 25678824, 25678828, 25678829, 25678833, 25678834, 25678838, 25680098, 25680099, 25704224, 25704225, 25704226, 25704227, 25704228, 25704229, 25739159, 25739160, 25739161, 25739162, 25739163, 25739164, 25739165, 25739166, 25739167, 25739168, 25788242, 25789369, 25789801, 25836093, 25836094, 25836095, 25836096, 25836097, 25836098, 25836099, 25836140, 25836141, 25836142, 25836143, 25836144, 25836145, 25878556, 25894780, 25894781, 25894782, 25916457, 25939485, 25939684, 25940126, 25940127, 25940131, 25947920, 25947921, 25975779, 25975780, 25975781, 25975782, 25975783, 25975784, 25975785, 25975786, 25975787, 26000581, 26000582, 26000583, 26000584, 26051925, 26051926, 26051927, 26058299, 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GTIN: 08714729283850 Exp. 05/18/2022 to 05/31/2023 | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution US Nationwide distribution. States below are derived from the distribution text, including nationwide wording. 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These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0325-2022%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Boston Scientific Corporation records](https://isitonrecall.com/brand/boston-scientific-corporation/)