MEGADYNE Suction Coagulators
Medical device recall Z-2257-2023. Published in FDA’s Enforcement Report on Aug 9, 2023.
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 9, 2023. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 241,457 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?
An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece. Fluid ingress can lead to intermittent device activation, non-activation, or self-activation when plugged into the electrosurgery unit (ESU).
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm), Bulk Non Sterile)
241,457 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product Code 004125: UDI-DI: 10614559105146, Batch Numbers: 183661 184078 183932 183978 184625 184161 185463 184714 185887 186028 185625 185757 186207 186128 186325 190281 190276 190147 190420 190618 190696 190638 191023 190751 191115…
Every code shown here, 1,994 characters
Product Code 004125: UDI-DI: 10614559105146, Batch Numbers: 183661 184078 183932 183978 184625 184161 185463 184714 185887 186028 185625 185757 186207 186128 186325 190281 190276 190147 190420 190618 190696 190638 191023 190751 191115 191424 191816 192724 192882 193070 193135 193211 193355 193449 193541 193390 193403 194160 194100 193579 193819 193958 194669 194613 195265 195597 194473 194777 194814 194358 194912 195044 195046 196082 186379 195736 196130 196129 196726 196624 196583 196956 197226 200458 200509 200447 200910 200973 202143 201381 201224 201431 202185 202229 202607 202268 203198 202299 203196 202315 202603 202606 203558 207076 208392 207075 202605 207834 207833 209000 202949 208391 208922 204137 210624 210429 203956 203672 210070 209144 207077 209460 210237 204299 208845 207832 207602 206689 204298 206750 209459 211798 210071 207764 207601 207600 211800 207222 206815 208921 208018 211801 208054 210025 210287 210285 210288 210510 209205 211799 210430 208053 210236 210092 210094 210093 210026 211802 208055 210072 208348 210286 208390 209255 208179 208178 SM2204025 SM2204023 SM2204019 SM2204022 SM2204024 SM2204027 SM2204021 SM2204020 SM2204026 SM2206034 SM2206038 SM2206035 SM2206039 SM2206036 SM2206037 SM2210032; Product Code 004225: UDI-DI: 10614559105153, Batch Numbers: 183863 185939 186249 186007 185713 190855 191581 191218 190452 191770 191342 193933 194392 193588 194071 196131 194203 195789 196858 200030 197301 196905 197138 200625 201515 201636 201778 208923 201971 205151 209430 210162 210965 209311 209312 210160 204300 205152 205379 209229 205573 205676 208589 209431 209254 208588 209357 210164 209355 208696 209429 210163 208678 209356 209142 210161 SM2204032 SM2201024 SM2204030 SM2204028 SM2204033 SM2204034 SM2204029 SM2206028 SM2206033 SM2206032 SM2206030 SM2206029 SM2206031 SM2210033; Product Code 004325: UDI-DI: 10614559105160, Batch Numbers: 183957 183704 183846 184405 184694 184711 185401 184888 185626 186280 186162 186064 185858 186445…
FDA’s list runs to 2,870 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 Distributions: US (Nationwide) and OUS (Foreign) in countries of: AUSTRALIA, BELGIUM, CANADA, CHILE, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, NEW ZEALAND, NORWAY, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, UNITED ARAB EMIRATES, UNITED KINGDOM, VIETNAM
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Jun 15, 2023.
- FDA classified it on Jul 28, 2023.
- FDA’s Enforcement Report published it on Aug 9, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Megadyne Medical Products, Inc., of Blue Ash, OH.
- 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 2,870 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.