Hand Control 12FR Suction Coagulator with 10 ft cord and holster — Class II medical device recall Z-1151-2014
Terminated recall by Megadyne Medical Products, Inc., reported 2014-03-19, distributed in FL, LA, MN, NJ, NM, PA, TX. Megadyne Medical Products, Inc. is voluntarily recalling Hand Control 12Fr Suction Coagulator with 10ft cord a
| Recall number | Z-1151-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Megadyne Medical Products, Inc., Draper, UT, United States |
| Recall initiated | 2014-02-27 |
| Classified | 2014-03-07 |
| Reported by FDA | 2014-03-19 |
| Terminated | 2014-07-09 |
| Distributed | FL, LA, MN, NJ, NM, PA, TX |
| Countries outside the US | CA |
| Quantity | 494 |
| Reason classes | sterility |
| Lot numbers | 132405 |
| Model numbers | 0043-25 |
| Expiration dates | 2018-07 |
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.
Reason for recall
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.
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-1151-2014. 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.