MEGADYNE Suction Coagulators — Class II medical device recall Z-2257-2023
Ongoing recall by Megadyne Medical Products, Inc., reported 2023-08-09, distributed nationwide. An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece. Fluid ingres
| Recall number | Z-2257-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Megadyne Medical Products, Inc., Blue Ash, OH, United States |
| Recall initiated | 2023-06-15 |
| Classified | 2023-07-28 |
| Reported by FDA | 2023-08-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, CL, DE, DK, EG, ES, FI, FR, GB, GR, HK, IE, IL, IN, IT, KR, NO, NZ, RU, SA, SE, SG, VN, ZA |
| Quantity | 241,457 units |
| UPC / GTIN / UDI-DI | 10614559103456, 10614559105146, 10614559105153, 10614559105160 |
| Lot numbers | 181362, 181463, 183661, 183704, 183846, 183863, 183932, 183957, 183978, 184078, 184161, 184405, 184625, 184694, 184711, 184714, 184784, 184885, 184888, 185401, 185463, 185528, 185560, 185623, 185625, 185626, 185713, 185747, 185757, 185858, 185887, 185939, 186007, 186028, 186064, 186128, 186162, 186207, 186249, 186280 and 317 more |
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 for recall
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).
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-2257-2023. 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.