CLASS II Device recall · Reported 14 Feb 2018 · FDA Enforcement Report

Disposable Light Handle Cover recalled by Ecolab

Ecolab is recalling Disposable Light Handle Cover, distributed in Michigan. The recall was initiated on 13 Oct 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/Item/Part No. B1-715-65, Lot Numbers: 14224, 14225, 14226, 14237, 14238, 14239, 14240, 14255, 14253, 14254, 14252, 14261, 14266, 14260, 14265, 14262, 14279, 14276, 14269, 14275, 14273, 14258, 14274, 14281, 14286, 14287, 14283, 14282, 14288, 14272, 14280, 14289, 14308, 14307, 14309, 14310, 14311, 14337, 14342, 14335, 14338, 14345, 14346, 14336, 14343, 14339, 14344, 15015, 15013, 15019, 15020, 15021, 15022, 15030, 15029, 15028, 15033, 15036, 15037, 15035, 15034, 15041, 15043, 15042, 15044, 15055, 15048, 15056, 15054, 15083, 15078, 15072, 15082, 15070, 15068, 15079, 15142, 15146, 15154, 15149, 15148, 15153, 15147, 15084, 15047, 15049, 15085, 15026, 15086, 15012, 15051, 15009, 15027, 15091, 15090, 15092, 15096, 15050, 15098, 15089, 15097, 15100, 15216, 15218, 15103, 15224, 15212, 15211, 15215, 15222, 15231, 15239, 15240, 15232, 15229, 15230, 15243, 15226, 15237, 15252, 15261, 15266, 15247, 15251, 15264, 15265, 15272, 15275, 15274, 15268, 15267, 15279, 15271, 15280, 15286, 15282, 15296, 15295, 15300, 15301, 15306, 15294, 15302, 15308, 15313, 15315, 15317, 15322, 15321, 15316, 15323, 15328, 15336, 15334, 15327, 15324, 15337, 15342, 15357, 16006, 16008, 15351, 15352, 16007, 15341, 16071, 15343, 15344, 16076, 16078, 16089, 16081, 16082, 16083, 16091, 16092, 16109, 16103, 16106, 16110, 16099, 16098, 16116, 16134, 16139, 16144, 16137, 16140, 16141, 16145, 16172, 16174, 16176, 16173, 16175, 16168, 16190, 16169, 16193, 16194, 16195, 16196, 16217, 16221, 16222, 16223, 16229, 16224, 16225, 16228, 16245, 16232, 16230, 16235, 16236, 16237, 16242, 16251, 16252, 16208, 16210, 16209, 16214, 16211, 16257, 16253, 16256, 16258, 16270, 16271, 16272, 16273, 16277, 16349, 16350, 16354, 16351, 16355, 16356, 17002, 16357, 17011, 17004, 17009, 17012, 17040, 17013, 17041, 17039, 17045, 17046, 17044, 17052, 17053, 17058, 17054, 17060, 17061, 17065, 17066, 17081, 17086, 17089, 17093, 17094, 17090, 17095, 17088, 17097, 17177, 17100, 17186, 17180, 17188, 17192, 17191

Quantity recalled5,958 cases (50 per case)

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-0523-2018
FDA event ID: 78419
Recalling firm: Ecolab, Saint Paul, MN
Classification: Class II
Status: Terminated
Recall initiated: 13 Oct 2017
FDA classified: 5 Feb 2018
Reported: 14 Feb 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

13 Oct 2017	Recall initiated by company
5 Feb 2018	Classified by FDA	+115 days
14 Feb 2018	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch.

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

Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device inside a peel pouch and sealed. Sealed pouches are packaged 10 each inside a poly liner. 5 rows of 10 pouches are placed in a labeled corrugated mailer box. Product Usage: Intended to be used as a disposable barrier for a surgical lighting system and which allows a surgical team member to manually adjust the lighting system. Single use device.

Where it was distributed

Distributed domestically to Michigan.

Michigan

Questions about this recall

Why was it recalled?

Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch.

Which lots are affected?

Model/Item/Part No. B1-715-65, Lot Numbers: 14224, 14225, 14226, 14237, 14238, 14239, 14240, 14255, 14253, 14254, 14252, 14261, 14266, 14260, 14265, 14262, 14279, 14276, 14269, 14275, 14273, 14258, 14274, 14281, 14286, 14287, 14283, 14282, 14288, 14272, 14280, 14289, 14308, 14307, 14309, 14310, 14311, 14337, 14342, 14335, 14338, 14345, 14346, 14336, 14343, 14339, 14344, 15015, 15013, 15019, 15020, 15021, 15022, 15030, 15029, 15028, 15033, 15036, 15037, 15035, 15034, 15041, 15043, 15042, 15044, 15055, 15048, 15056, 15054, 15083, 15078, 15072, 15082, 15070, 15068, 15079, 15142, 15146, 15154, 15149, 15148, 15153, 15147, 15084, 15047, 15049, 15085, 15026, 15086, 15012, 15051, 15009, 15027, 15091, 15090, 15092, 15096, 15050, 15098, 15089, 15097, 15100, 15216, 15218, 15103, 15224, 15212, 15211, 15215, 15222, 15231, 15239, 15240, 15232, 15229, 15230, 15243, 15226, 15237, 15252, 15261, 15266, 15247, 15251, 15264, 15265, 15272, 15275, 15274, 15268, 15267, 15279, 15271, 15280, 15286, 15282, 15296, 15295, 15300, 15301, 15306, 15294, 15302, 15308, 15313, 15315, 15317, 15322, 15321, 15316, 15323, 15328, 15336, 15334, 15327, 15324, 15337, 15342, 15357, 16006, 16008, 15351, 15352, 16007, 15341, 16071, 15343, 15344, 16076, 16078, 16089, 16081, 16082, 16083, 16091, 16092, 16109, 16103, 16106, 16110, 16099, 16098, 16116, 16134, 16139, 16144, 16137, 16140, 16141, 16145, 16172, 16174, 16176, 16173, 16175, 16168, 16190, 16169, 16193, 16194, 16195, 16196, 16217, 16221, 16222, 16223, 16229, 16224, 16225, 16228, 16245, 16232, 16230, 16235, 16236, 16237, 16242, 16251, 16252, 16208, 16210, 16209, 16214, 16211, 16257, 16253, 16256, 16258, 16270, 16271, 16272, 16273, 16277, 16349, 16350, 16354, 16351, 16355, 16356, 17002, 16357, 17011, 17004, 17009, 17012, 17040, 17013, 17041, 17039, 17045, 17046, 17044, 17052, 17053, 17058, 17054, 17060, 17061, 17065, 17066, 17081, 17086, 17089, 17093, 17094, 17090, 17095, 17088, 17097, 17177, 17100, 17186, 17180, 17188, 17192, 17191

Where was it sold?

Distributed domestically to Michigan.

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 26 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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