X-Stream Irrigation System — Class II medical device recall Z-1457-2022
Ongoing recall by Davol, Inc., reported 2022-08-03, distributed nationwide. The device may potentially cause a fire, leading to a safety risk.
| Recall number | Z-1457-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Davol, Inc., Warwick, RI, United States |
| Recall initiated | 2022-06-27 |
| Classified | 2022-07-22 |
| Reported by FDA | 2022-08-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CL |
| UPC / GTIN / UDI-DI | 00801741010118 |
| Lot numbers | 41DPNX01, 41EPNX01, 41IMNX01, 41JPNX01, 41KPNX01, 43JQD249, DAAP5991, DAAP5992, DAAP5994, DAAP5995, DAAP5996, DAAP5997, DAAP5998, DAAP5999, DAAP6000, DAAP6001, DAAP6002, DAAP6003, DAAP6004, DAAP6005, DAAP6006, DAAP6007, DAAP6008, DAAP6009, DAAP6010, DAAP6011, DAAP6012, DAAP6013, DAAP6014, DAAP6015, DAAP6016, DAAP6017, DAAP6018, DAAP6019, DAAP6020, DAAP6021, DAAP6022, DAAP6023, DAAP6024, DAAP6025 and 460 more |
| Model numbers | 1402V3, 416MNX02, 41AMNB36, 41AMNX01, 41AMNX03, 41AMXN01, 41ANMB40, 41AONX01, 41AONX02, 41AONXOL, 41BMMB36, 41BMMX01, 41BMN01, 41BMNX01, 41CLAT29, 41DONX01, 41EMN103, 41EMNX01, 41EMNX02, 41EMNX03, 41EMX01, 41EMXN01, 41EMXX03, 41EPNX01, 41FPNX01 and 209 more |
Product
X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)
Reason for recall
The device may potentially cause a fire, leading to a safety risk.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1457-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.