CLASS II Device recall · Reported 19 Mar 2014 · FDA Enforcement Report

Hand Control Suction Coagulator with 10 ft cord and holster recalled

Megadyne Medical Products is recalling Hand Control Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, distributed nationwide in the US. The recall was initiated on 27 Feb 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: 0043-25 Lot Number: 132405 Exp. Date: 07-2018

Quantity recalled494

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1151-2014
FDA event ID: 67641
Recalling firm: Megadyne Medical Products, Draper, UT
Classification: Class II
Status: Terminated
Recall initiated: 27 Feb 2014
FDA classified: 7 Mar 2014
Reported: 19 Mar 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

27 Feb 2014	Recall initiated by company
7 Mar 2014	Classified by FDA	+8 days
19 Mar 2014	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

USA including FL, MN, LA, NJ, NM, PA, TX and Internationally to Canada.

Nationwide Florida Louisiana Minnesota New Jersey New Mexico Pennsylvania Texas

Stores named: Target

Questions about this recall

Is Hand Control Suction Coagulator with 10 ft cord and holster, Sterile, Disposable recalled?

Yes. Megadyne Medical Products recalled Hand Control Suction Coagulator with 10 ft cord and holster, Sterile, Disposable on 27 Feb 2014. The recall is Class II and its status is Terminated. Recall number Z-1151-2014.

Why was it recalled?

Which lots are affected?

Catalog Number: 0043-25 Lot Number: 132405 Exp. Date: 07-2018

Where was it sold?

USA including FL, MN, LA, NJ, NM, PA, TX and Internationally to Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Megadyne Medical Products

All 19

Reported	Class	Recall	Company	Reason	Where
10 Jul 2024Device	CLASS I	Megadyne" Mega Soft" Dual Reusable Patient Return Electrode recalled	Megadyne Medical Products	Device Malfunction	Nationwide
10 Jul 2024Device	CLASS I	Megadyne" Mega 2000" Patient Return Electrode recalled	Megadyne Medical Products	Device Malfunction	Nationwide
10 Jul 2024Device	CLASS I	Megadyne" Mega Soft" Reusable Patient Return Electrode recalled	Megadyne Medical Products	Device Malfunction	Nationwide
12 Jun 2024Device	CLASS I	Megadyne Mega Soft Pediatric Patient Return Electrode recalled	Megadyne Medical Products	Other	Nationwide
3 Jan 2024Device	CLASS I	Product Code 0845, Megadyne Mega Soft Universal Patient Return recalled	Megadyne Medical Products	Lead & Heavy Metals	Nationwide

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide