Endoscopic Cleaning Brush — Class II medical device recall Z-3210-2018
Terminated recall by Medline Industries Inc, reported 2018-09-26, distributed nationwide. There is potential risk of brush detachment during cleaning. If brush detachment is not identified, there is t
| Recall number | Z-3210-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries Inc, Northfield, IL, United States |
| Recall initiated | 2018-06-15 |
| Classified | 2018-09-20 |
| Reported by FDA | 2018-09-26 |
| Terminated | 2020-05-18 |
| Distributed | Nationwide (US) |
| Quantity | 183,606 devices |
| Reason classes | device malfunction |
| Lot numbers | 17JA1424, 17JA1514, 17JA2093, 17KA1032, 17KA1034, 17KA1644, 17KA1944, 17KA1969, 17LA0422, 17LA0460, 17LA0481, 17LA1157, 17LA1178, 17LA1373, 17LA1462, 17LA1648, 17LA1730, 17LA1984, 17LA2004, 17LA2210, 18AA0783, 18AA0914, 18AA0941, 18AA0950, 18AA0963, 18AA0984, 18AA1963, 18AA2019, 18AA2110, 18AA2114, 18AA2211, 18AA2529, 18BA0029, 18BA0055, 18BA0062, 18BA0211, 18BA0284, 18BA0411, 18BA0475, 18BA0551 and 314 more |
| Model numbers | DYK1002DBDE, DYK1002DBSE, DYK1002DCB, DYK1002SBC |
Product
Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a. Item Number DYK1002DCB, BRUSH, CLEANING, DOUBLE ENDED, W/ HANDLE - 300 EA/CS, 50EA/BX, 6BX/CS; b. Item Number DYK1002DBDE, BRUSH, CLEANING, DBL, DIF ENDS - 500 EA/CS, 50 EA/BX, 10 BX/CS; c. Item Number DYK1002DBSE, BRUSH, CLEANING, DBL, SAME END - 500 EA/CS, 50 EA/BX, 10 BX/CS; d. Item Number DYK1002SBC, BRUSH, CLEANING, SINGLE END - 500 EA/CS, 50 EA/BX, 10 BX/CS
Reason for recall
There is potential risk of brush detachment during cleaning. If brush detachment is not identified, there is the potential for the brush to be left within the scope.
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-3210-2018. 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.