X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)
Check against the official notice below — it lists the full affected range.
Davol, Inc. is recalling the X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000) because the device may potentially cause a fire, creating a safety risk. The recall affects 9,420 units worldwide, including 9,337 in the United States and 83 units in Canada and Chile. The recalled devices are identified by UDI-DI: 00801741010118 and include numerous lot and serial numbers listed in the official recall notice.
The recall notice does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The device may potentially cause a fire, leading to a safety risk.
Reason for recall: The device may potentially cause a fire, leading to a safety risk. Distribution: Worldwide distribution - US Nationwide and the countries of Canada and Chile. Quantity: 9420 (9337 in US; 83 OUS) Lot/code info: UDI-DI: 00801741010118 All lots Catalog No. 5551000: 41HLNX03 41ILNX01 41ILNY01 41ILNY03 ST5313 41ILNX02 41LNX02 41HLN103 ST6533 41JLNX02 41JLNX01 41KLNX01 ST6558 ST5304 ST7450 41AMNB36 41LLNX03 ST5302 ST5303 ST7527 ST7524 41LLNX01 41AMNX01 41bmnx01 41LLNX02 41bmn01 ST5306 41clat29 ST5308 ST9445 41KLNX02 ST9366 ST9367 41BMMB36 ST8144 ST8145 ST8267 41AMNX03 41JLNZ02 41EMNX03 ST8313 41EMNX02 41AMXN01 41EMNX01 ST8826 ST8789 ST9925 43EMNX03 SN#J0405 SN#DJ0405 DJ0479 DJ0463 DJ0451 DJ0517 DJ0476 DJ0438 DJ0465 DJ0467 DJ0518 EB1032EA0776EA0782 DJO366 DJO045 DJO359 DJ0366 DJ0045 DJ0359 DJ0765 DL0625 DL0694 DL0690 DK0591 4BMNX01 41HMNX02 41IMNX01 41INMX01 ST10500 ST10165 EH2070V3 EH2008V3 EH2007V3 EH2025V3 EH2004V3 41IMNX02 ST8668 EH2010V3 DI0282 41JMNX01 41GMNX01 41GMNOX02 41GMNX02 41HMNX01 EI2145V3 EI2130V3 EI2147V3 EI2146V3 EI2163V3 ST10888 ST11290 EB0991 EG1652V3 ST11141 41EMN103 416mnx02 EG1579V3 EG1561V3 EG1605V3 EG1562V3 EG1674V3 DK0590 DJ0380 DJ0393 ST10896 DL0640 DL0664 41GMNZ02 41GMNX03 41EMXX03 41GLNX02 EG1623V3 EG1772V3 EG1625V3 DJ0345 EB0916V3 EB0950V3 EB0965V3 EB0966V3 EE1305V3 EE1446V3 41BMMX01 ee1170v3 ee1174v3 ee1199v3 ee1210v3 41EMX01 eb0935v3 eb0989v3 eb0995v3 eb1017v3 41EMXN01 EE1327V3 EE1303V3 EE1421V3 ee1167v3 sn ee1204v3 EA0781 DG0078V3 EI2288V3 EE1171V3 EE1202V3 EE1183V3 EE1189V3 EE1207V3 EE1212V3 ee1180v3 ee1187v3 ee1208v3 EG1504V3 DK0536V3 EI2277V3 EI2296V3 ST11995 EB1161 EE1344 ST13037 41MNX001 41mnxx01 41mnx01 ST13127 41hmx01 ST13559 41anmb40 41EMNX01 41EMNX
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.