Class II — Megadyne Medical Products, Inc.
| Recalling firm | Megadyne Medical Products, Inc. |
|---|---|
| Registered facility | MEGADYNE MEDICAL PRODUCTS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Megadyne Medical Products, Inc. is voluntarily recalling Hand Control 12Fr Suction Coagulator with 10ft cord and 132405 Holster, Sterile, Disposable, Lot 132405 due to the potential for a small number of these suction coagulators to self-activate immediately on connection to the electrosurgical generator and to remain activated until it is disconnected. |
| Product | Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek® polyester peel pouch, 25 pouches per box. This device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator (ESU) to target tissue during ENT and general surgical procedures. It is also a suction apparatus used to remove surgical smoke and fluids from the site. The device is intended for single use; it is not intended to be cleaned or reused. |
| Quantity | 494 |
| Distribution | USA including FL, MN, LA, NJ, NM, PA, TX and Internationally to Canada. |
| Initiated | 2014-02-27 |
| Classified | 2014-03-07 |
| Terminated | 2014-07-09 |
| Recall number | Z-1151-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Megadyne Medical Products, Inc. (Z-1151-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67641/
Alerts for Megadyne Medical Products, Inc.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.