X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No.…
Medical device recall Z-1457-2022. Published in FDA’s Enforcement Report on Aug 3, 2022.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Aug 3, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 9420 (9337 in US; 83 OUS) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The device may potentially cause a fire, leading to a safety risk.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)
9420 (9337 in US; 83 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,997 characters
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 41EMNX03 41BMNX01 STEG1737V3 EG1800V3 EG1737V3 EE1237V3 EE1283V3 STEB0938V3 EB1034V3 EB0938V3 DL0623 EH1837V3 EE1279V3 EA0780 SE1368V3 EB1079V3 EB1115V3 EE1180 EE1442 EE1318 EE1383 1402V3 EE1385 EE1402V3 EE1442V3 EE1318V3 EE1383V3 EG1779V3 EH1992V3 DH00207V3 DH0207V3 ST16676 ST16596 ST16773 DJ0495VS DJ0467VS ST17314 EA0819V3 EG1599V3 EG1525V3 41aonx01 EE1172V3 EE1192V3 41aonxol 41gonx01 41aonx02 ga2454v3 GA2437V3 41donx01 STE4333 41konx01 STE5063 DJ0480V3 STE5188 DK0543V3 GA2388V3 STE5640 41epnx01…
FDA’s list runs to 31,566 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution - US Nationwide and the countries of Canada and Chile.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 27, 2022.
- FDA classified it on Jul 22, 2022.
- FDA’s Enforcement Report published it on Aug 3, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Davol, Inc., of Warwick, RI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 31,566 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.