FDA Device recall Z-1457-2022
X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)
- FDA Device
- Class II
- ongoing
- Published 2022-08-03
On 2022-08-03 the FDA classified a Class II recall of X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000) by Davol, citing the device may potentially cause a fire, leading to a safety risk.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1457-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-06-27 |
| Published | 2022-08-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Davol |
| Distribution | US |
Product
X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)
Reason
The device may potentially cause a fire, leading to a safety risk.
Identifiers
| code_info | UDI-DI: 00801741010118 All lots Catalog No. 5551000: 41HLNX03 41ILNX01 41ILNY01 41ILNY03 ST5313 41ILNX02 41LNX02 41HLN…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 41GMNX |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1457-2022%22
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