FDA Device recall Z-2257-2023
MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suctio…
- FDA Device
- Class II
- ongoing
- Published 2023-08-09
On 2023-08-09 the FDA classified a Class II recall of MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suctio… by Megadyne Medical Products, citing an issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece. Fluid ingress can lead to intermittent device activation, non-activation, or self….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2257-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-15 |
| Published | 2023-08-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Megadyne Medical Products |
| Distribution | US |
Product
MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm), Bulk Non Sterile)
Reason
An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece. Fluid ingress can lead to intermittent device activation, non-activation, or self-activation when plugged into the electrosurgery unit (ESU).
Identifiers
| code_info | Product Code 004125: UDI-DI: 10614559105146, Batch Numbers: 183661 184078 183932 183978 184625 184161 185463 184714 185…Product Code 004125: UDI-DI: 10614559105146, Batch Numbers: 183661 184078 183932 183978 184625 184161 185463 184714 185887 186028 185625 185757 186207 186128 186325 190281 190276 190147 190420 190618 190696 190638 191023 190751 191115 191424 191816 192724 192882 193070 193135 193211 193355 193449 193541 193390 193403 194160 194100 193579 193819 193958 194669 194613 195265 195597 194473 194777 194814 194358 194912 195044 195046 196082 186379 195736 196130 196129 196726 196624 196583 196956 197226 200458 200509 200447 200910 200973 202143 201381 201224 201431 202185 202229 202607 202268 203198 202299 203196 202315 202603 202606 203558 207076 208392 207075 202605 207834 207833 209000 202949 208391 208922 204137 210624 210429 203956 203672 210070 209144 207077 209460 210237 204299 208845 207832 207602 206689 204298 206750 209459 211798 210071 207764 207601 207600 211800 207222 206815 208921 208018 211801 208054 210025 210287 210285 210288 210510 209205 211799 210430 208053 210236 210092 21 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2257-2023%22
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