Drug recall
MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch…
FDA recall event 92456 · Class II · Megadyne Medical Products, Inc.
Key facts
| Event ID | 92456 |
|---|---|
| Recall numbers | Z-2257-2023 |
| Recalling firm | Megadyne Medical Products, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jun 15, 2023 |
| Report date | Aug 9, 2023 |
| City | Blue Ash |
| State | OH |
| Country | United States |
| FEI number | 1721194 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: