Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 19, 2014
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
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 potenti…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Megadyne Medical Products, Inc. recalled Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Mo… - a moderate-severity action.
Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Mo… was recalled by Megadyne Medical Products, Inc. in March 19, 2014. Reason: Megadyne Medical Products, Inc. is voluntarily recalling Hand Control 12Fr Suction Coagulator with 10ft cord …. Check the official notice for the remedy. Verify recall #Z-1151-2014 with the FDA Devices before acting.
The recall
Megadyne Medical Products, Inc. issued this moderate-severity FDA Devices recall-Megadyne Medical Products, Inc. is voluntarily recalling Hand Control 12Fr Suction Coagulator with 10ft cord ….
- Moderate
- severity level
- 494 units
- affected scope
- Class II
- classification
- March 19, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1151-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1151-2014) was formally reported on March 19, 2014, with the manufacturer initiating the action on February 27, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Megadyne Medical Products, Inc. is listed as the recalling firm, operating out of Draper, UT. Federal records list the affected scope as 494.
The documented reason for this recall is: 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 c… Distribution data in the federal record shows the product reached: USA including FL, MN, LA, NJ, NM, PA, TX and Internationally to Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
494
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1151-2014 |
| Date reported | March 19, 2014 |
| Date initiated | February 27, 2014 |
| Recalling firm | Megadyne Medical Products, Inc. |
| Firm location | Draper, UT |
| Affected scope | 494 |
| Distribution | USA including FL, MN, LA, NJ, NM, PA, TX and Internationally to Canada. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1151-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Megadyne Medical Products, Inc.. Units affected: 494.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 19, 2014. Severity: Moderate. Recall number: Z-1151-2014.
Where was the recalled product distributed? ▼
Distribution: USA including FL, MN, LA, NJ, NM, PA, TX and Internationally to Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1151-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 19, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.