FDA Device recall Z-0264-2025
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
- FDA Device
- Class II
- ongoing
- Published 2024-11-06
On 2024-11-06 the FDA classified a Class II recall of Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U by Olympus, citing there was an increase in complaints indicating an occurrence of system error E1226 "Could not write to Audio Buffer" during procedures using the ESG-410 (SEP).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0264-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-04 |
| Published | 2024-11-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Olympus |
| Distribution | US |
Product
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
Reason
There was an increase in complaints indicating an occurrence of system error E1226 "Could not write to Audio Buffer" during procedures using the ESG-410 (SEP).
Identifiers
| code_info | UDI-DI: 04042761087698; Serial Numbers: 101698 102191 102706 103016 103068 103112 103161 103199 101702 102195 102707 10…UDI-DI: 04042761087698; Serial Numbers: 101698 102191 102706 103016 103068 103112 103161 103199 101702 102195 102707 103018 103069 103114 103162 103200 101920 102197 102709 103019 103072 103115 103163 103201 101923 102266 102710 103020 103073 103116 103165 103203 101925 102427 102711 103025 103074 103117 103166 103206 101929 102660 102712 103026 103075 103119 103167 103207 101932 102661 102713 103029 103076 103120 103168 103208 101933 102664 102714 103030 103077 103121 103169 103209 101934 102665 102715 103031 103078 103122 103170 103210 101937 102668 102716 103033 103080 103123 103172 103211 101945 102672 102717 103034 103081 103124 103173 103212 101947 102673 102718 103035 103082 103125 103174 103214 102149 102674 102719 103037 103083 103126 103176 103215 102150 102678 102721 103041 103084 103127 103177 103216 102153 102679 102722 103042 103085 103132 103178 103217 102154 102681 102723 103043 103087 103133 103179 103218 102155 102682 102724 103044 103088 103134 103180 103219 102156 1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0264-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.