--- title: "HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictur... — FDA record Z-0327-2022 | 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-0327-2022-hurricane-rx-dilation-balloon-10mm-4cm-for-endoscopic-dilatation-of-strictures-of-the-biliary-tree-a/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter... — FDA record Z-0327-2022 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 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545960 - **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-0327-2022 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0327-2022%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: 25608761, 25640116, 25640117, 25644834, 25649819, 25649824, 25649829, 25649834, 25678825, 25678830, 25678835, 25678839, 25678880, 25680560, 25704230, 25704231, 25704232, 25739169, 25739170, 25806714, 25819946, 25819947, 25819948, 25836147, 25836148, 25850475, 25850476, 25850477, 25850478, 25850479, 25850540, 25850541, 25878986, 25878987, 25878988, 25878989, 25878990, 25878991, 25930854, 25940128, 25940129, 25940130, 25963979, 25969161, 25969162, 25975788, 25975789, 25975790, 25975791, 26010399, 26010400, 26047895, 26047896, 26047897, 26047898, 26047899, 26048760, 26058432, 26059172, 26123198, 26123199, 26123240, 26123241, 26123242, 26123243, 26123252, 26123253, 26175502, 26175503, 26175504, 26175505, 26207999, 26208000, 26208001, 26208002, 26208003, 26240379, 26247286, 26247287, 26247288, 26247289, 26284152, 26284153, 26284154, 26284155, 26284156, 26324769, 26324771, 26324773, 26324775, 26350409, 26356442, 26366767, 26366768, 26366769, 26366770, 26366771, 26366772, 26366773, 26366774, 26406539, 26406560, 26406561, 26406562, 26435589, 26435590, 26435591, 26440046, 26457040, 26457041, 26473800, 26473801, 26489988, 26491481, 26491482, 26491483, 26491484, 26499145, 26543699, 26545849, 26545850, 26545851, 26546369, 26549973, 26559545, 26581409, 26581410, 26581827, 26600543, 26600544, 26621751, 26628098, 26638074, 26651704, 26651705, 26651706, 26651709, 26674679, 26675080, 26675081, 26677000, 26677001, 26677002, 26686240, 26696688, 26696689, 26706795, 26706796, 26706797, 26718376, 26718377, 26739329, 26739331, 26739335, 26758738, 26759340, 26759342, 26760526, 26760527, 26760528, 26760529, 26779086, 26779087, 26779088, 26779089, 26779090, 26779092, 26779093, 26808304, 26808305, 26808306, 26808307, 26848733, 26848734, 26848735, 26848736, 26848737, 26888169, 26888170, 26888171, 26888172, 26919342, 26919343, 26919344, 26919345, 26940195, 26940196, 26940197, 26940198, 26990983, 26990984, 26990985, 26990986, 26990987, 26990988, 26990989, 26990990, 26990991, 27008809, 27008810, 27008811, 27008812, 27055019, 27055120, 27062059, 27065900, 27065901, 27074115, 27074116, 27121590, 27121591, 27121596, 27121598, 27121599, 27121626, 27148639, 27148780, 27148781, 27183303, 27183304, 27183305, 27183311, 27183312, 27219848, 27220333, 27233915, 27263158, 27263159, 27265233, 27265234, 27269980, 27269981, 27269982, 27308428, 27335462, 27347597, 27347598, 27384710, 27428069 GTIN: 08714729283874 Exp. 05/18/2022 to 06/03/2023 | 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. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Dec 8, 2021 - **Recall initiation date**: Oct 21, 2021 - **Center classification date**: Dec 1, 2021 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. 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-0327-2022%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Boston Scientific Corporation records](https://isitonrecall.com/brand/boston-scientific-corporation/)