MegaPower Electrosurgical Generator
Medical device recall Z-2792-2018. Published in FDA’s Enforcement Report on Aug 22, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Aug 22, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 8380 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
If two devices are plugged into the same channel/port in the generator, both devices activate. If one device is left laying on the patient, the result could be burning of the patient.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715
8380 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
00001001 00010001 13806001 00053001 00063001 00066001 00070001 00078001 00085001 00091001 00100001 00105001 00110001 00115001 00128001 00132001 00146001 00167001 00181001 00187001 00191001 00200001 00211001 00212001 00223001 00229001…
Every code shown here, 2,000 characters
00001001 00010001 13806001 00053001 00063001 00066001 00070001 00078001 00085001 00091001 00100001 00105001 00110001 00115001 00128001 00132001 00146001 00167001 00181001 00187001 00191001 00200001 00211001 00212001 00223001 00229001 00237001 00240001 00242001 00246001 00248001 00254001 00265001 00278001 00282001 00283001 00308001 00313001 00313001 00314001 00333001 00334001 00379001 00380001 00391001 00398001 00402001 00413001 00416001 00418001 00424001 00432001 00437001 00438001 00458001 00459001 00471001 00479001 00481001 00484001 00524001 00535001 00543001 00551001 00553001 00554001 00574001 00586001 00590001 00619001 00627001 00632001 00638001 00639001 00640001 00658001 00685001 00690001 00693001 00707001 00708001 00710001 00721001 00725001 00728001 00731001 00740001 00779001 00796001 00801001 00804001 00813001 00816001 00829001 00841001 00847001 00848001 00859001 00868001 00871001 00872001 00884001 00890001 00899001 00904001 00905001 00906001 00922001 00932001 00935001 00937001 00943001 00951001 00952001 00953001 00959001 00960001 00978001 00982001 00988001 1003001 1007001 1020001 1023001 1032001 1034001 1043001 1055001 1065001 1069001 1070001 1083001 1088001 1092001 1109001 1110001 1115001 1119001 1120001 1126001 1134001 1135001 1144001 1153001 1158001 1176001 1182001 1190001 1195001 1201001 1213001 1219001 1224001 1227001 1237001 1241001 1279001 1284001 1293001 1294001 1300001 1319001 1320001 1331001 1332001 1337001 1345001 1346001 1351001 1360001 1361001 1390001 1392001 1393001 1422001 1425001 1434001 1440001 1442001 1448001 1451001 1452001 1459001 1462001 1474001 1477001 1484001 1490001 1495001 1497001 1510001 1516001 1520001 1525001 1529001 1536001 1558001 1562001 1566001 1574001 1596001 1598001 1601001 1608001 1612001 1613001 1623001 1625001 1649001 1650001 1656001 1659001 1667001 1674001 1682001 1686001 1727001 1729001 1732001 1752001 1762001 1771001 1773001 1800001 1815001 1823001 1824001 1831001 1833001 1837001 1839001 1844001 1845001 1847001 1880001…
FDA’s list runs to 84,695 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution. US Nationwide, Mexico, Europe, Middle East, Latin America, Africa, and Asia Pacific Markets
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 15, 2018.
- FDA classified it on Aug 13, 2018.
- FDA’s Enforcement Report published it on Aug 22, 2018.
- FDA terminated it on Jan 30, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Megadyne Medical Products, Inc., of Draper, UT.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 84,695 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.