Z-1151-2014Class II

Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25...

Name: Z-1151-2014 Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25...
Creator: Megadyne Medical Products, Inc.
Published: 2014-02-27
License: https://open.fda.gov/license/

Megadyne Medical Products, Inc / initiated 2014-02-27 / Terminated / root cause: sterility

FDA source

Megadyne Medical Products, Inc. began a recall of Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek polyester peel pouch, 25 pouches... on 2014-02-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1151-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-27
Posted: 2014-03-07
Terminated: 2014-07-09
Recalling firm: Megadyne Medical Products, Inc
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
Root cause tag: sterility
FDA root cause: Use error
Action: Megadyne Medical Product sent an Urgent Medical Device Recall letter dated February 27, 2014, to all affected customers with follow-up phone calls and emails. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed toexamine their inventory immediately to determine if they have any of the affected product. If so, customers were instructed to remove the product from service and contact Megadyne Customer Service at 1-801-576-9669 or 1-800-747-6110 for return authorization and replacement or credit. If customers have distributed any the affected product, they were instructed to immediately contact their distribution points to have the product returned to Megadyne. Customers with questions were instructed to contact Customer Service at 1-800-747-6110 or 1-801-576-9669 or email Regulatory @Megadyne.com. For questions regarding this recall call 801-576-9669.
Quantity in commerce: 494
Distribution: USA including FL, MN, LA, NJ, NM, PA, TX and Internationally to Canada.
Product codes and lots: Catalog Number: 0043-25 Lot Number: 132405 Exp. Date: 07-2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1151-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1151-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-07

Product code GEI

K072559Class IISuction CoagulatorMegadyne Medical Products, Inc. / cleared 2007-10-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)