CLASS II Device recall · Reported 19 Apr 2017 · FDA Enforcement Report

Sterile Handpiece Sheaths recalled by ConMed

ConMed is recalling Sterile Handpiece Sheaths, distributed nationwide in the US. The recall was initiated on 28 Feb 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 1540070, 15450384, 15500476, 16020037, 16150086, 16260128, 16360182, 16450236, 15320037, 15450385, 15500477, 16020038, 16150087, 16260129, 16360183, 16450237, 15330049, 15450386, 15500478, 16020039, 16150088, 16260130, 16360184, 16450238, 15330052, 15450387, 15500479, 16020040, 16150089, 16260131, 16360185, 16450239, 15330053, 15450388, 15500480, 16040041, 16150090, 16260132, 16360186, 16450240, 15340074, 15450389, 15500481, 16040042, 16180091, 16260133, 16360187, 16460241, 15350086, 15450390, 15500482, 16040043, 16180091, 16260134, 16360188, 16460244, 15360096, 15450391, 15500483, 16040044, 16180092, 16260135, 16360189, 16460246, 15360105, 15450392, 15500484, 16040045, 16180092, 16260136, 16360190, 16460248, 15360108, 15450393, 15500485, 16040046, 16180093, 16260137, 16410191, 16460249, 15400254, 15460398, 15500486, 16040047, 16180094, 16260138, 16410192, 16460250, 15400255, 15480434, 15500487, 16040048, 16180095, 16260139, 16410193, 16500266, 15400256, 15480435, 15500488, 16040049, 16180096, 16260140, 16410194, 16500267, 15400257, 15480436, 15500489, 16040050, 16180097, 16260141, 16410195, 16500270, 15400258, 15480437, 15500490, 16040051, 16180098, 16260142, 16410196, 16500271, 15400259, 15480438, 15500491, 16040052, 16180099, 16260143, 16410197, 16500272, 15400260, 15480439, 15500492, 16040053, 16180100, 16260144, 16410198, 16500274, 15400261, 15480440, 15500493, 16040054, 16180101, 16260145, 16410199, 16500275, 15400262, 15480441, 16010001, 16040055, 16180102, 16260146, 16410200, 16500277, 15400263, 15480442, 16010002, 16040056, 16180103, 16260147, 16420201, 16500278, 15400264, 15480443, 16010003, 16040056, 16180104, 16260148, 16420202, 16500279, 15400265, 15480444, 16010004, 16040057, 16180105, 16260149, 16420203, 16500280, 15400266, 15480445, 16010005, 16040057, 16180106, 16260150, 16420204, 154000269, 15400267, 15480446, 16010006, 16040058, 16180107, 16260151, 16420205, 15400268, 15480447, 16010007, 16040058, 16180108, 16260152, 16420206, 15400270, 15480448, 16010008, 16040059, 16180109, 16260153, 16420207, 15400271, 15480449, 16010009, 16040059, 16180110, 16260154, 16420208, 15400272, 15480450, 16010010, 16040060, 16200111, 16260155, 16420209, 15400273, 15480451, 16010011, 16040060, 16200112, 16260156, 16420210, 15400274, 15480452, 16010012, 16040061, 16200113, 16260157, 16430211, 15400275, 15480453, 16010013, 16040062, 16200114, 16260158, 16430212, 15400276, 15480453, 16010014, 16040063, 16200115, 16260159, 16430213, 15400277, 15490454, 16010015, 16040064, 16200116, 16260160, 16430214, 15400278, 15490455, 16010016, 16040065, 16200117, 16260161, 16430215, 15400279, 15490456, 16010017, 16040066, 16200118, 16260162, 16430216, 15400280, 15490457, 16010018, 16040067, 16200119, 16260163, 16430217, 15400281, 15490458, 16010019, 16040068, 16200120, 16260164, 16430218, 15400282, 15490459, 16010020, 16040069, 16220121, 16260165, 16430219, 15400283, 15490460, 16020021, 16040070, 16220122, 16260166, 16430220, 15400284, 15490461, 16020022, 16040071, 16220123, 16260167, 16430221, 15400285, 15490462, 16020023, 16040072, 16220124, 16260168, 16430222, 15400286, 15490463, 16020024, 16040073, 16220125, 16260169, 16430223, 15400287, 15490464, 16020025, 16040074, 16220126, 16260170, 16430224, 15400288, 15490465, 16020026, 16040075, 16220127, 16360171, 16430225, 15410331, 15490466, 16020027, 16040076, 16220128, 16360172, 16430226, 15450374, 15490467, 16020028, 16040077, 16220129, 16360173, 16430227, 15450375, 15490468, 16020029, 16040078, 16220130, 16360174, 16430228, 15450376, 15490469, 16020030, 16040079, 16260121, 16360175, 16430229, 15450377, 15490470, 16020031, 16040080, 16260122, 16360176, 16430230, 15450378, 15490471, 16020032, 16150081, 16260123, 16360177, 16450231, 15450379, 15490472, 16020033, 16150082, 16260124, 16360178, 16450232, 15450380, 15490473, 16020034, 16150083, 16260125, 16360179, 16450233, 15450381, 15500474, 16020035, 16150084, 16260126, 16360180, 16450234, 15450383, 15500475, 16020036, 16150085, 16260127, 16360181, 16450235.

Quantity recalledN/A

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-1758-2017
FDA event ID: 76482
Recalling firm: ConMed, Utica, NY
Classification: Class II
Status: Terminated
Recall initiated: 28 Feb 2017
FDA classified: 7 Apr 2017
Reported: 19 Apr 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

28 Feb 2017	Recall initiated by company
7 Apr 2017	Classified by FDA	+38 days
19 Apr 2017	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

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.

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

Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons , 220 VOLTS AC, REF/Catalog Number 7-900-220, Rx Only, There is no problem with the Hyfrecator 2000 Electrosurgical Units --- ASSEMBLED IN MEXICO -- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502 ---

Where it was distributed

Worldwide Distribution - US (nationwide) Internationally to Australia, Canada, Germany, Italy, UK, Great Britain, and Ireland.

Nationwide

Questions about this recall

Is Sterile Handpiece Sheaths recalled?

Yes. ConMed recalled Sterile Handpiece Sheaths on 28 Feb 2017. The recall is Class II and its status is Terminated. Recall number Z-1758-2017.

Why was it recalled?

Which lots are affected?

Serial Numbers: 1540070, 15450384, 15500476, 16020037, 16150086, 16260128, 16360182, 16450236, 15320037, 15450385, 15500477, 16020038, 16150087, 16260129, 16360183, 16450237, 15330049, 15450386, 15500478, 16020039, 16150088, 16260130, 16360184, 16450238, 15330052, 15450387, 15500479, 16020040, 16150089, 16260131, 16360185, 16450239, 15330053, 15450388, 15500480, 16040041, 16150090, 16260132, 16360186, 16450240, 15340074, 15450389, 15500481, 16040042, 16180091, 16260133, 16360187, 16460241, 15350086, 15450390, 15500482, 16040043, 16180091, 16260134, 16360188, 16460244, 15360096, 15450391, 15500483, 16040044, 16180092, 16260135, 16360189, 16460246, 15360105, 15450392, 15500484, 16040045, 16180092, 16260136, 16360190, 16460248, 15360108, 15450393, 15500485, 16040046, 16180093, 16260137, 16410191, 16460249, 15400254, 15460398, 15500486, 16040047, 16180094, 16260138, 16410192, 16460250, 15400255, 15480434, 15500487, 16040048, 16180095, 16260139, 16410193, 16500266, 15400256, 15480435, 15500488, 16040049, 16180096, 16260140, 16410194, 16500267, 15400257, 15480436, 15500489, 16040050, 16180097, 16260141, 16410195, 16500270, 15400258, 15480437, 15500490, 16040051, 16180098, 16260142, 16410196, 16500271, 15400259, 15480438, 15500491, 16040052, 16180099, 16260143, 16410197, 16500272, 15400260, 15480439, 15500492, 16040053, 16180100, 16260144, 16410198, 16500274, 15400261, 15480440, 15500493, 16040054, 16180101, 16260145, 16410199, 16500275, 15400262, 15480441, 16010001, 16040055, 16180102, 16260146, 16410200, 16500277, 15400263, 15480442, 16010002, 16040056, 16180103, 16260147, 16420201, 16500278, 15400264, 15480443, 16010003, 16040056, 16180104, 16260148, 16420202, 16500279, 15400265, 15480444, 16010004, 16040057, 16180105, 16260149, 16420203, 16500280, 15400266, 15480445, 16010005, 16040057, 16180106, 16260150, 16420204, 154000269, 15400267, 15480446, 16010006, 16040058, 16180107, 16260151, 16420205, 15400268, 15480447, 16010007, 16040058, 16180108, 16260152, 16420206, 15400270, 15480448, 16010008, 16040059, 16180109, 16260153, 16420207, 15400271, 15480449, 16010009, 16040059, 16180110, 16260154, 16420208, 15400272, 15480450, 16010010, 16040060, 16200111, 16260155, 16420209, 15400273, 15480451, 16010011, 16040060, 16200112, 16260156, 16420210, 15400274, 15480452, 16010012, 16040061, 16200113, 16260157, 16430211, 15400275, 15480453, 16010013, 16040062, 16200114, 16260158, 16430212, 15400276, 15480453, 16010014, 16040063, 16200115, 16260159, 16430213, 15400277, 15490454, 16010015, 16040064, 16200116, 16260160, 16430214, 15400278, 15490455, 16010016, 16040065, 16200117, 16260161, 16430215, 15400279, 15490456, 16010017, 16040066, 16200118, 16260162, 16430216, 15400280, 15490457, 16010018, 16040067, 16200119, 16260163, 16430217, 15400281, 15490458, 16010019, 16040068, 16200120, 16260164, 16430218, 15400282, 15490459, 16010020, 16040069, 16220121, 16260165, 16430219, 15400283, 15490460, 16020021, 16040070, 16220122, 16260166, 16430220, 15400284, 15490461, 16020022, 16040071, 16220123, 16260167, 16430221, 15400285, 15490462, 16020023, 16040072, 16220124, 16260168, 16430222, 15400286, 15490463, 16020024, 16040073, 16220125, 16260169, 16430223, 15400287, 15490464, 16020025, 16040074, 16220126, 16260170, 16430224, 15400288, 15490465, 16020026, 16040075, 16220127, 16360171, 16430225, 15410331, 15490466, 16020027, 16040076, 16220128, 16360172, 16430226, 15450374, 15490467, 16020028, 16040077, 16220129, 16360173, 16430227, 15450375, 15490468, 16020029, 16040078, 16220130, 16360174, 16430228, 15450376, 15490469, 16020030, 16040079, 16260121, 16360175, 16430229, 15450377, 15490470, 16020031, 16040080, 16260122, 16360176, 16430230, 15450378, 15490471, 16020032, 16150081, 16260123, 16360177, 16450231, 15450379, 15490472, 16020033, 16150082, 16260124, 16360178, 16450232, 15450380, 15490473, 16020034, 16150083, 16260125, 16360179, 16450233, 15450381, 15500474, 16020035, 16150084, 16260126, 16360180, 16450234, 15450383, 15500475, 16020036, 16150085, 16260127, 16360181, 16450235.

Where was it sold?

Worldwide Distribution - US (nationwide) Internationally to Australia, Canada, Germany, Italy, UK, Great Britain, and Ireland.

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.

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