Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000…
Medical device recall Z-1757-2017. Published in FDA’s Enforcement Report on Apr 19, 2017.
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 Apr 19, 2017. Copied from openFDA on Oct 20, 2026.
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?
For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to use a non-sterile sheath as if it were sterile.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 115 VOLTS AC, REF/Catalog Number 7-900-115, Rx Only . There is no problem with the Hyfrecator 2000 Electrosurgical Units. -- ASSEMBLED IN MEXICO --- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502 The Hyfrecator 2000 Electrosurgical Unit is indicated for use in conjunction with an electrosurgical accessory handpiece for delivery of high frequency electrosurgical current through an accessory electrode for cutting and coagulation at the operative site. The sterile sheaths are intended to cover the electrosurgical handpiece during those typical electrosurgical procedures and reduce the effort necessary to re-sterilize the handpiece between procedures.
How much: “N/A”, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 1618320 16020102 16070492 16110883 16171279 16231666 16382087 16402485 16442884 16493284 1618330 16020103 16070493 16110884 16171280 16231667 16382088 16412486 16442885 16493285 13181360 16020104 16070494 16110885 16171281…
Every code shown here, 1,994 characters
Serial Numbers: 1618320 16020102 16070492 16110883 16171279 16231666 16382087 16402485 16442884 16493284 1618330 16020103 16070493 16110884 16171280 16231667 16382088 16412486 16442885 16493285 13181360 16020104 16070494 16110885 16171281 16231668 16382089 16412487 16442886 16493286 15010013 16020105 16070495 16120886 16171282 16231669 16382090 16412488 16442887 16493287 15070434 16020106 16070496 16120887 16171283 16231670 16382091 16412489 16442888 16493288 15221592 16020107 16070497 16120888 16171284 16231671 16382092 16412490 16442889 16493289 15221593 16020108 16070498 16120889 16171285 16231672 16382093 16412491 16442890 16493290 15221594 16020109 16070499 16120890 16171286 16231673 16382094 16412492 16442891 16493291 15221595 16020110 16070500 16120891 16171287 16231674 16382095 16412493 16442892 16493292 15221596 16020111 16080501 16120892 16171288 16231675 16382096 16412494 16442893 16493293 15221597 16020112 16080502 16120893 16171289 16231676 16382097 16412495 16442894 16493294 15221598 16020113 16080503 16120894 16171290 16231677 16382098 16412496 16442895 16493295 15221599 16020114 16080504 16120895 16171291 16231678 16382099 16412497 16442896 16493296 15221600 16020115 16080505 16120896 16171292 16231679 16382100 16412498 16442897 16493297 15240221 16020116 16080506 16120897 16171293 16231680 16382101 16412499 16442898 16493298 15250297 16020117 16080507 16120898 16171294 16231681 16382102 16412500 16442899 16493299 15300642 16020118 16080508 16120899 16171295 16231682 16382103 16412501 16442900 16493301 15300651 16020119 16080509 16120900 16171296 16231683 16382104 16412502 16442901 16493302 15320844 16020120 16080510 16120901 16171297 16231684 16382105 16412503 16442902 16493303 15320846 16020121 16080511 16120902 16171298 16231685 16382106 16412504 16442903 16493304 15320849 16020122 16080512 16120903 16171299 16231686 16382107 16412505 16442904 16493305 15330856 16020123 16080513 16120904 16171300 16231687 16382108 16412506 16442905 16493306…
FDA’s list runs to 34,873 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) Internationally to Australia, Canada, Germany, Italy, UK, Great Britain, and Ireland.
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 Feb 28, 2017.
- FDA classified it on Apr 7, 2017.
- FDA’s Enforcement Report published it on Apr 19, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- ConMed Corporation, of Utica, NY.
- 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 34,873 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.