FDA Device recall Z-3210-2018
Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a. Item Number DYK1002DCB, BRUSH, CLEANING, DOUBLE ENDED,…
- FDA Device
- Class II
- terminated
- Published 2018-09-26
On 2018-09-26 the FDA classified a Class II recall of Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a. Item Number DYK1002DCB, BRUSH, CLEANING, DOUBLE ENDED,… by Medline Industries, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3210-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-15 |
| Published | 2018-09-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medline Industries |
| Distribution | US |
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
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.
Identifiers
| code_info | Endoscopic cleaning brush finished good lot numbers: GM10, GJ25, HA05, HA20. Kits: a. Item Number DYK1002DCB, k…Endoscopic cleaning brush finished good lot numbers: GM10, GJ25, HA05, HA20. Kits: a. Item Number DYK1002DCB, kit Number (Kit Lot Number): DYK1001DCB (18BA0735), DYK1002144B (18BA0644, 18DA0124), DYK1008972E (18BA2199, 18DA1418, 18EAA023, 18EAA653), DYK1012268E1 (18BA1667, 18CA0872, 18CA1289, 18DA1732), DYK1012414E1 (18CA0793, 18CA1644, 18DA0413), DYK1017922E (18CA1300), DYK1018542E (18CA0622, 18DA1159, 18EAB507), DYK1044978E (18EBE085, 18NB1289), DYK1067817E1 (18AA1969, 18EAA004, 18EAB365), DYK1072097E (18DA0437, 18EAA790), DYK1097615E (18CA0687, 18EAA084), DYK1177017E (18BA2352, 18DA1481), DYK1188722E (18EAA016, 18EAB529), DYK1253578E (18AA2092, 18DA0331), DYK1253578F (18DA1595), DYK1266757E (18BA0203, 18DA0062, 18DF0085), DYKE1003A (18DA1488, 18FAA025), DYKE1011B (18AA1276), DYKE1012C (18DA0090, 18EAA521), DYKE1013 (18CB4388, 18EBL745), DYKE1014B (17KA1195, 18AA0984, 18CA0691, 18CA1969, 18DA0344, 18DA1167), DYKE1022A (18EBE830), DYKE1029C (18BA0279, 18CA0842), DYKE1032C (1 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3210-2018%22
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