CLASS II Device recall · Reported 24 Apr 2019 · FDA Enforcement Report

Acusnare Polypectomy (Duck Bill Shaped) Snare Used recalled

Wilson-Cook Medical is recalling Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for, distributed nationwide in the US. The recall was initiated on 4 Jan 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesASDB-15-015- S with Lot #'s W4010785, W4010787, W4010788, W4010789, W4010791, W4010792, W4010793, W4010794, W4010795, W4010796, W4010797, W4010799, W4010801, W4010802, W4010803, W4010804, W4010805, W4010806, W4012291, W4012292, W4012294, W4012295, W4012296, W4012300, W4013231, W4015568, W4015569, W4015570, W4015571, W4015572, W4015574, W4015575, W4015576, W4015577, W4015578, W4018215, W4018216, W4018217, W4018219, W4018220, W4018221, W4018222, W4018223, W4019733, W4019734, W4019735, W4019736, W4019738, W4019739, W4019742, W4019743, W4019744, W4020127, W4020128, W4020129, W4020130, W4020131, W4020132, W4020133, W4020134, W4021578, W4021579, W4021580, W4021581, W4021582, W4021583, W4021584, W4021585, W4021586, W4021587, W4021588, W4021589, W4021591, W4021598, W4023828, W4023835, W4023836, W4023837, W4023838, W4023839, W4023840, W4023841, W4023843, W4023844, W4023845, W4024369, W4024370, W4024371, W4024372, W4024373, W4024374, W4025299, W4025300, W4025301, W4025302, W4025303, W4025304, W4025305, W4025332, W4025337, W4025338, W4025339, W4025342, W4025343, W4025344, W4025345, W4025347, W4025348, W4025349, W4025350, W4025351, W4026852, W4026853, W4026854, W4026861, W4026862, W4026863, W4026864, W4026867, W4026868, W4026869, W4026870, W4026874, W4026875, W4026876, W4028204, W4028207, W4028208, W4028838, W4028840, W4028841, W4028842, W4028843, W4028844, W4028845, W4028846, W4028847, W4028848, W4028849, W4029402, W4029403, W4029404, W4029408, W4029410, W4029411, W4029412, W4029413, W4029414, W4029415, W4029416, W4029417, W4029418, W4029988, W4029989, W4029990, W4029991, W4029993, W4029994, W4029995, W4031839, W4031840, W4031841, W4031842, W4031843, W4031844, W4033749, W4033751, W4033752, W4033755, W4033756, W4033757, W4035185, W4035186, W4035187, W4035188, W4035950, W4035951, W4035952, W4035953, W4035954, W4035955, W4035956, W4035957, W4035958, W4035959, W4035960, W4035961, W4035962, W4036659, W4036661, W4036663, W4036664, W4036665, W4036666, W4036667, W4036824, W4036825, W4036827, W4036828, W4036829, W4036833, W4036834, W4036835, W4036836, W4038384, W4038385, W4038386, W4038387, W4038388, W4038389, W4038390, W4038764, W4038765, W4038766, W4038767, W4039337, W4039338, W4039339, W4039340, W4039341, W4039342, W4039343, W4039344, W4039345, W4039346, W4040557, W4040558, W4040559, W4040560, W4040561, W4041764, ,W4041768, W4043628, W4044770, W4044771, W4045381, W4045382, W4045383, W4045384, W4045385, W4045386, W4045387, W4045388, W4045389, W4045390, W4047726, W4047727, W4047728, W4048929, W4048930, W4048931, W4048932, W4048933, W4048934, W4048935, W4048936, W4049885, W4049895, W4049896, W4049897, W4051087, W4051093, W4051770, W4051772, W4051773, W4052558, W4052560, W4052561, W4052562, W4053058, W4053059, W4053060, W4053061, W4053062, W4053660, W4053661, W4053662, W4053663, W4053664, W4053665, W4053666, W4053667, W4056455, W4056456, W4056457, W4058230, W4058234, W4058235, W4059450, W4059451, W4059452, W4060209, W4060210, W4060211, W4060213, W4061432, W4061433, W4061434, W4061435, W4061440, W4061441, W4062017, W4062028, W4062029, W4062030, W4062031, W4062032, W4062633, W4062635, W4062636, W4062638, W4063529, W4064384, W4065132, W4065133, W4065134, W4065135, W4065136, W4065137, W4066650, W4066651, W4066658, W4066659, W4066660, W4067360, W4067361, W4067362, W4067895, W4067906, W4067909, W4067910, W4067911, W4068623, W4068625, W4068626, W4068627, W4068628, W4069129, W4069131, W4069132, W4069133, W4069134, W4069139, W4069140, W4070127, W4070128, W4070129, W4070131, W4070132, W4070714, W4070715, W4070717, W4070718, W4070719, W4070720, W4070721, W4070722, W4070723, W4071340, W4071341, W4071342, W4071343, W4071693, W4071694, W4071695, W4071696, W4071697, W4071701, W4071702, W4071703, W4072882, W4072884, W4072885, W4072886, W4072888, W4072889, W4072905, W4075173, W4075174, W4075175, W4075177, W4075178, W4075181, W4075182, W4075183, W4075185, W4076681, W4076682, W4076683, W4076684, W4076685, W4076686, W4076687, W4080002, W4080003, W4080004, W4080005, W4080006, W4080007, W4080008, W4080009, W4080010, W4080011, W4080713, W4080714, W4080715, W4080716, W4080717, W4080718, W4080719, W4080721, W4085548, W4085549, W4085550, W4085554, W4085556, W4085557, W4085558, W4085559, W4085560, W4085561, W4087633, W4087634, W4087635, W4087636, W4087637, W4087638, W4087639, W4087640, W4087641, W4087642, W4087646, W4087647, W4088977, W4088978, W4088979, W4088980, W4088981, W4088982, W4088983, W4088984, W4090948, W4090949, W4090950, W4090951, W4090952, W4090954, W4090955, W4090956, W4090958, W4090959, W4092759, W4092760, W4092763, W4092764, W4092765, W4092766, W4092767, W4095494, W4095495, W4095497, W4095498, W4095502, W4096097, W4096098, W4096099, W4096100, W4096101, W4096102, W4096103, W4096104, W4097782, W4097783, W4097784, W4097785, W4097786, W4097787, W4098209, W4098210, W4098211, W4098212, W4098213, W4098214, W4098215, W4098216, W4098217, W4098218, W4098219, W4098220, W4099939, W4099940, W4099941, W4099942, W4099943, W4099944, W4099945, W4099946, W4099947, W4099948, W4099950, W4099951, W4099952, W4099953, W4099957, W4099958, W4099960, W4099961, W4099962, W4099963, W4099964, W4099965, W4101131, W4101132, W4101133, W4101146, W4101147, W4101148, W4101149, W4101150, W4101151, W4101152, W4101153, W4104061, W4104064, W4104065, W4104067, W4104068, W4104069, W4104072, W4104073, W4104074, W4104076, W4104077, W4104078, W4104079, W4104080, W4104081, W4104919, W4105321, W4105322, W4105325, W4105326, W4105327, W4105328, W4105330, W4105331, W4105332, W4105333, W4105334, W4105335, W4105336, W4105337, W4105338, W4105343, W4105344, W4105867, W4105868, W4105869, W4106539, W4106540, W4106541, W4106545, W4106546, W4106547, W4108503, W4108504, W4108505, W4108508, W4108509, W4108511, W4108512, W4108513, W4109251, W4109253, W4109255, W4109256, W4109257, W4109258, W4109259, W4109260, W4109261, W4110676, W4111693, W4112208, W4112210, W4112211, W4112212, W4112213, W4112215, W4112216, W4112217, W4112218, W4112219, W4112220, W4112469, W4112470, W4112471, W4112472, W4112473, W4114772, W4114773, W4114774, W4114775, W4114776, W4114777, W4115063, W4115067, W4115068, W4115088, W4115089, W4115092, W4115983, W4115984, W4115985, W4115986, W4115987, W4115989, W4115992, W4115993, W4115994, W4115996, W4115997, W4115998, W4115999, W4116000, W4117692, W4118914, W4118915, W4118916, W4118917, W4118918, W4118920, W4118921, W4118922, W4118923, W4118924, W4118925, W4119506, W4119507, W4119508, W4119509, W4119510, W4119511, W4119512, W4119516, W4121009, W4121010, W4121014, W4121015, W4121022, W4121023, W4121024, W4121025, W4123474, W4123475, W4124351, W4124352, W4124353, W4124354, W4124355, W4124358, W4124359, W4125872, W4125873, W4125875, W4125876, W4125877, W4125878, W4125880, W4125881, W4125882, W4125883, W4127525, W4127526, W4127539, W4127540, W4127541, W4127542, W4127543, W4127544, W4127545, W4127546, W4130717, W4131793, W4131802, W4131803, W4132494, W4132495, W4133749, W4133750, W4134800, W4134804, W4134805, W4135742, W4135743, W4135744, W4135745, W4136590, W4136591, W4136592, W4137115, W4137116, W4137117, W4137118, W4137119, W4137120, W4137121, W4137122, W4137939, W4137940, W4137941, W4138485, W4138486, W4138487, W4139793, W4139794, W4139795, W4139796, W4139797, W4141324, W4141877, W4141878, W4141879, W4141880, W4143473, W4143474, W4143477, W4143478, W4143481, W4143482, W4144785, W4144786, W4144787, W4144790, W4144791, W4144792, W4144793, W4144794, W4144795, W4146100, W4146101, W4146102, W4146693, W4146694, W4146695, W4146696, W4146699, W4146700, W4146701, W4147116, W4147118, W4147119, W4147122, W4147123, W4149074, W4149075, W4149076, W4149078, W4149079, W4149516, W4149650, W4149651, W4149652, W4149653, W4149654, W4149655, W4151991, W4151992, W4151993, W4151994, W4151995, W4151996, W4152952, W4153609, W4153615, W4153616, W4153619, W4153620, W4153621, W4154529, W4154530, W4154560, W4154561, W4154562, W4154563, W4155253, W4155254, W4155255, W4155256, W4155257, W4155258, W4156092, W4156093, W4156094, W4156098, and W4156099 ASDB-25-015-S with Lot #'s W4010786, W4010807, W4010808, W4010809, W4012276, W4012277, W4012278, W4012293, W4012297, W4012298, W4012299, W4012301, W4012302, W4012303, W4012304, W4012305, W4012306, W4015579, W4015580, W4018218, W4018224, W4018225, W4018226, W4019737, W4019740, W4019741, W4019745, W4020135, W4020136, W4020137, W4020754, W4020976, W4020977, W4021004, W4021005, W4021006, W4021590, W4023842, W4023846, W4024368, W4024375, W4024376, W4025306, W4025333, W4025334, W4025335, W4025336, W4025340, W4025341, W4025346, W4026865, W4026866, W4026871, W4026872, W4026873, W4026877, W4026878, W4028177, W4028178, W4028205, W4028206, W4028837, W4029396, W4029397, W4029398, W4029399, W4029400, W4029401, W4029405, W4029406, W4029407, W4029409, W4029419, W4029420, W4029421, W4029422, W4029423, W4029424, W4029992, W4029996, W4029997, W4031837, W4031838, W4031845, W4031846, W4031847, W4031848, W4031849, W4031850, W4033746, W4033747, W4033748, W4033750, W4033753, W4033754, W4035189, W4035190, W4035191, W4035192, W4035193, W4036657, W4036658, W4036660, W4036662, W4036668, W4036669, W4036670, W4036671, W4036826, W4036830, W4036831, W4036832, W4036837, W4038391, W4038392, W4038393, W4038394, W4038395, W4038396, W4038397, W4038398, W4041010, W4041011, W4041012, W4041013, W4041014, W4041015, W4041765, W4041766, W4041767, W4043627, W4043629, W4043630, W4044772, W4044773, W4045391, W4045392, W4045393, W4046004, W4046280, W4046281, W4046282, W4046283, W4047729, W4047730, W4047731, W4047732, W4049876, W4049877, W4049878, W4049886, W4049898, W4049899, W4051086, W4051771, W4051885, W4052556, W4052557, W4052559, W4054324, W4054325, W4054326, W4054327, W4056458, W4056459, W4056460, W4056461, W4058228, W4058229, W4058231, W4058232, W4058233, W4058236, W4058237, W4059453, W4059454, W4060212, W4060214, W4060216, W4060217, W4060218, W4061436, W4062018, W4062019, W4062634, W4062637, W4062639, W4062640, W4063527, W4063528, W4063530, W4067363, W4067896, W4067907, W4067912, W4069130, W4069135, W4069136, W4069137, W4069138, W4070130, W4070133, W4070713, W4070716, W4071339, W4071344, W4071345, W4071346, W4071347, W4071698, W4071699, W4071700, W4071704, W4071705, W4072883, W4072887, W4072890, W4072891, W4075172, W4075176, W4075179, W4075180, W4075184, W4076673, W4076674, W4076675, W4076676, W4076677, W4076678, W4076679, W4076680, W4076688, W4076689, W4076690, W4076691, W4077443, W4077444, W4077446, W4080720, W4085551, W4085552, W4085553, W4085555, W4085562, W4085563, W4085564, W4085565, W4085566, W4087643, W4087644, W4087645, W4087648, W4088916, W4088917, W4088918, W4088919, W4088920, W4088921, W4088922, W4088923, W4088924, W4090953, W4090957, W4090960, W4090961, W4090962, W4090963, W4090964, W4090965, W4090966, W4092761, W4092762, W4092768, W4092769, W4092770, W4092771, W4092772, W4092773, W4092774, W4095496, W4095499, W4095500, W4095501, W4096105, W4096106, W4096107, W4096108, W4096109, W4096110, W4097793, W4097794, W4097795, W4098221, W4098222, W4098235, W4099949, W4099954, W4099955, W4099956, W4099959, W4099966, W4099967, W4099968, W4099969, W4099970, W4099971, W4101154, W4101155, W4101156, W4101157, W4101158, W4101159, W4101160, W4101161, W4104062, W4104063, W4104066, W4104070, W4104071, W4104075, W4104082, W4104083, W4104084, W4105323, W4105324, W4105329, W4105339, W4105340, W4105870, W4105871, W4106536, W4106538, W4106542, W4106543, W4106544, W4106548, W4106549, W4108506, W4108507, W4108510, W4108514, W4108515, W4109252, W4109254, W4109262, W4109263, W4109264, W4111075, W4111076, W4111077, W4111078, W4111246, W4111252, W4111258, W4111260, W4111261, W4111694, W4111695, W4111696, W4111697, W4114771, W4115988, W4115990, W4115991, W4115995, W4116001, W4116002, W4116003, W4116004, W4116527, W4117693, W4119513, W4119514, W4119515, W4119517, W4119518, W4119686, W4121011, W4121016, W4121026, W4122214, W4122215, W4122216, W4123472, W4123473, W4123476, W4123477, W4124356, W4124357, W4124360, W4125874, W4125879, W4125884, W4125885, W4127547, W4127548, W4129308, W4129309, W4129310, W4129311, W4130716, W4130718, W4130719, W4131791, W4131794, W4131795, W4132491, W4132492, W4132493, W4132496, W4132497, W4132498, W4133114, W4133751, W4133752, W4134801, W4134806, W4135746, W4135751, W4135752, W4136593, W4136594, W4136595, W4137942, W4138480, W4138488, W4138489, W4138490, W4138491, W4139798, W4141323, W4141881, W4141882, W4143475, W4143476, W4143479, W4143480, W4143483, W4144788, W4144789, W4144796, W4144797, W4144798, W4144799, W4144801, W4144802, W4146103, W4147117, W4147120, W4147121, W4147124, W4149077, W4149080, W4149081, W4149656, W4149657, W4149658, W4152950, W4152951, W4152953, W4153610, W4153617, W4153618, W4153622, W4155250, W4155251, W4155252, W4155259, W4155260, W4155261, W4156091, W4156095, W4156096, W4156097, and W4156100.

Quantity recalled34,456 units

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-1132-2019
FDA event ID: 81956
Recalling firm: Wilson-Cook Medical, Winston Salem, NC
Classification: Class II
Status: Terminated
Recall initiated: 4 Jan 2019
FDA classified: 12 Apr 2019
Reported: 24 Apr 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

4 Jan 2019	Recall initiated by company
12 Apr 2019	Classified by FDA	+98 days
24 Apr 2019	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

Complaints of the snare loop not completely retracting and/or misshaping of the snare loop.

Product as listed by the FDA

Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.

Where it was distributed

Worldwide Distribution: US (nationwide) in the states of: AL, AR, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY; and countries of: ARGENTINA, BRAZIL, CANADA, MEXICO, NETHERLANDS ANTILLES, AUSTRIA, BELARUS, BELGIUM, FINLAND, FRANCE, GERMANY, ITALY, NETHERLANDS, POLAND, PORTUGAL, RUSSIAN FEDERATION, SLOVAKIA, SLOVENIA, SPAIN, SWEDEN, SWITZERLAND, UNITED ARAB EMIRATES, UNITED KINGDOM, AUSTRALIA, CHINA, INDIA, NEW ZEALAND, TAIWAN, REPUBLIC OF CHINA and THAILAND.

Nationwide Alabama Arkansas California Colorado Connecticut Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri

Questions about this recall

Why was it recalled?

Complaints of the snare loop not completely retracting and/or misshaping of the snare loop.

Which lots are affected?

ASDB-15-015- S with Lot #'s W4010785, W4010787, W4010788, W4010789, W4010791, W4010792, W4010793, W4010794, W4010795, W4010796, W4010797, W4010799, W4010801, W4010802, W4010803, W4010804, W4010805, W4010806, W4012291, W4012292, W4012294, W4012295, W4012296, W4012300, W4013231, W4015568, W4015569, W4015570, W4015571, W4015572, W4015574, W4015575, W4015576, W4015577, W4015578, W4018215, W4018216, W4018217, W4018219, W4018220, W4018221, W4018222, W4018223, W4019733, W4019734, W4019735, W4019736, W4019738, W4019739, W4019742, W4019743, W4019744, W4020127, W4020128, W4020129, W4020130, W4020131, W4020132, W4020133, W4020134, W4021578, W4021579, W4021580, W4021581, W4021582, W4021583, W4021584, W4021585, W4021586, W4021587, W4021588, W4021589, W4021591, W4021598, W4023828, W4023835, W4023836, W4023837, W4023838, W4023839, W4023840, W4023841, W4023843, W4023844, W4023845, W4024369, W4024370, W4024371, W4024372, W4024373, W4024374, W4025299, W4025300, W4025301, W4025302, W4025303, W4025304, W4025305, W4025332, W4025337, W4025338, W4025339, W4025342, W4025343, W4025344, W4025345, W4025347, W4025348, W4025349, W4025350, W4025351, W4026852, W4026853, W4026854, W4026861, W4026862, W4026863, W4026864, W4026867, W4026868, W4026869, W4026870, W4026874, W4026875, W4026876, W4028204, W4028207, W4028208, W4028838, W4028840, W4028841, W4028842, W4028843, W4028844, W4028845, W4028846, W4028847, W4028848, W4028849, W4029402, W4029403, W4029404, W4029408, W4029410, W4029411, W4029412, W4029413, W4029414, W4029415, W4029416, W4029417, W4029418, W4029988, W4029989, W4029990, W4029991, W4029993, W4029994, W4029995, W4031839, W4031840, W4031841, W4031842, W4031843, W4031844, W4033749, W4033751, W4033752, W4033755, W4033756, W4033757, W4035185, W4035186, W4035187, W4035188, W4035950, W4035951, W4035952, W4035953, W4035954, W4035955, W4035956, W4035957, W4035958, W4035959, W4035960, W4035961, W4035962, W4036659, W4036661, W4036663, W4036664, W4036665, W4036666, W4036667, W4036824, W4036825, W4036827, W4036828, W4036829, W4036833, W4036834, W4036835, W4036836, W4038384, W4038385, W4038386, W4038387, W4038388, W4038389, W4038390, W4038764, W4038765, W4038766, W4038767, W4039337, W4039338, W4039339, W4039340, W4039341, W4039342, W4039343, W4039344, W4039345, W4039346, W4040557, W4040558, W4040559, W4040560, W4040561, W4041764, ,W4041768, W4043628, W4044770, W4044771, W4045381, W4045382, W4045383, W4045384, W4045385, W4045386, W4045387, W4045388, W4045389, W4045390, W4047726, W4047727, W4047728, W4048929, W4048930, W4048931, W4048932, W4048933, W4048934, W4048935, W4048936, W4049885, W4049895, W4049896, W4049897, W4051087, W4051093, W4051770, W4051772, W4051773, W4052558, W4052560, W4052561, W4052562, W4053058, W4053059, W4053060, W4053061, W4053062, W4053660, W4053661, W4053662, W4053663, W4053664, W4053665, W4053666, W4053667, W4056455, W4056456, W4056457, W4058230, W4058234, W4058235, W4059450, W4059451, W4059452, W4060209, W4060210, W4060211, W4060213, W4061432, W4061433, W4061434, W4061435, W4061440, W4061441, W4062017, W4062028, W4062029, W4062030, W4062031, W4062032, W4062633, W4062635, W4062636, W4062638, W4063529, W4064384, W4065132, W4065133, W4065134, W4065135, W4065136, W4065137, W4066650, W4066651, W4066658, W4066659, W4066660, W4067360, W4067361, W4067362, W4067895, W4067906, W4067909, W4067910, W4067911, W4068623, W4068625, W4068626, W4068627, W4068628, W4069129, W4069131, W4069132, W4069133, W4069134, W4069139, W4069140, W4070127, W4070128, W4070129, W4070131, W4070132, W4070714, W4070715, W4070717, W4070718, W4070719, W4070720, W4070721, W4070722, W4070723, W4071340, W4071341, W4071342, W4071343, W4071693, W4071694, W4071695, W4071696, W4071697, W4071701, W4071702, W4071703, W4072882, W4072884, W4072885, W4072886, W4072888, W4072889, W4072905, W4075173, W4075174, W4075175, W4075177, W4075178, W4075181, W4075182, W4075183, W4075185, W4076681, W4076682, W4076683, W4076684, W4076685, W4076686, W4076687, W4080002, W4080003, W4080004, W4080005, W4080006, W4080007, W4080008, W4080009, W4080010, W4080011, W4080713, W4080714, W4080715, W4080716, W4080717, W4080718, W4080719, W4080721, W4085548, W4085549, W4085550, W4085554, W4085556, W4085557, W4085558, W4085559, W4085560, W4085561, W4087633, W4087634, W4087635, W4087636, W4087637, W4087638, W4087639, W4087640, W4087641, W4087642, W4087646, W4087647, W4088977, W4088978, W4088979, W4088980, W4088981, W4088982, W4088983, W4088984, W4090948, W4090949, W4090950, W4090951, W4090952, W4090954, W4090955, W4090956, W4090958, W4090959, W4092759, W4092760, W4092763, W4092764, W4092765, W4092766, W4092767, W4095494, W4095495, W4095497, W4095498, W4095502, W4096097, W4096098, W4096099, W4096100, W4096101, W4096102, W4096103, W4096104, W4097782, W4097783, W4097784, W4097785, W4097786, W4097787, W4098209, W4098210, W4098211, W4098212, W4098213, W4098214, W4098215, W4098216, W4098217, W4098218, W4098219, W4098220, W4099939, W4099940, W4099941, W4099942, W4099943, W4099944, W4099945, W4099946, W4099947, W4099948, W4099950, W4099951, W4099952, W4099953, W4099957, W4099958, W4099960, W4099961, W4099962, W4099963, W4099964, W4099965, W4101131, W4101132, W4101133, W4101146, W4101147, W4101148, W4101149, W4101150, W4101151, W4101152, W4101153, W4104061, W4104064, W4104065, W4104067, W4104068, W4104069, W4104072, W4104073, W4104074, W4104076, W4104077, W4104078, W4104079, W4104080, W4104081, W4104919, W4105321, W4105322, W4105325, W4105326, W4105327, W4105328, W4105330, W4105331, W4105332, W4105333, W4105334, W4105335, W4105336, W4105337, W4105338, W4105343, W4105344, W4105867, W4105868, W4105869, W4106539, W4106540, W4106541, W4106545, W4106546, W4106547, W4108503, W4108504, W4108505, W4108508, W4108509, W4108511, W4108512, W4108513, W4109251, W4109253, W4109255, W4109256, W4109257, W4109258, W4109259, W4109260, W4109261, W4110676, W4111693, W4112208, W4112210, W4112211, W4112212, W4112213, W4112215, W4112216, W4112217, W4112218, W4112219, W4112220, W4112469, W4112470, W4112471, W4112472, W4112473, W4114772, W4114773, W4114774, W4114775, W4114776, W4114777, W4115063, W4115067, W4115068, W4115088, W4115089, W4115092, W4115983, W4115984, W4115985, W4115986, W4115987, W4115989, W4115992, W4115993, W4115994, W4115996, W4115997, W4115998, W4115999, W4116000, W4117692, W4118914, W4118915, W4118916, W4118917, W4118918, W4118920, W4118921, W4118922, W4118923, W4118924, W4118925, W4119506, W4119507, W4119508, W4119509, W4119510, W4119511, W4119512, W4119516, W4121009, W4121010, W4121014, W4121015, W4121022, W4121023, W4121024, W4121025, W4123474, W4123475, W4124351, W4124352, W4124353, W4124354, W4124355, W4124358, W4124359, W4125872, W4125873, W4125875, W4125876, W4125877, W4125878, W4125880, W4125881, W4125882, W4125883, W4127525, W4127526, W4127539, W4127540, W4127541, W4127542, W4127543, W4127544, W4127545, W4127546, W4130717, W4131793, W4131802, W4131803, W4132494, W4132495, W4133749, W4133750, W4134800, W4134804, W4134805, W4135742, W4135743, W4135744, W4135745, W4136590, W4136591, W4136592, W4137115, W4137116, W4137117, W4137118, W4137119, W4137120, W4137121, W4137122, W4137939, W4137940, W4137941, W4138485, W4138486, W4138487, W4139793, W4139794, W4139795, W4139796, W4139797, W4141324, W4141877, W4141878, W4141879, W4141880, W4143473, W4143474, W4143477, W4143478, W4143481, W4143482, W4144785, W4144786, W4144787, W4144790, W4144791, W4144792, W4144793, W4144794, W4144795, W4146100, W4146101, W4146102, W4146693, W4146694, W4146695, W4146696, W4146699, W4146700, W4146701, W4147116, W4147118, W4147119, W4147122, W4147123, W4149074, W4149075, W4149076, W4149078, W4149079, W4149516, W4149650, W4149651, W4149652, W4149653, W4149654, W4149655, W4151991, W4151992, W4151993, W4151994, W4151995, W4151996, W4152952, W4153609, W4153615, W4153616, W4153619, W4153620, W4153621, W4154529, W4154530, W4154560, W4154561, W4154562, W4154563, W4155253, W4155254, W4155255, W4155256, W4155257, W4155258, W4156092, W4156093, W4156094, W4156098, and W4156099 ASDB-25-015-S with Lot #'s W4010786, W4010807, W4010808, W4010809, W4012276, W4012277, W4012278, W4012293, W4012297, W4012298, W4012299, W4012301, W4012302, W4012303, W4012304, W4012305, W4012306, W4015579, W4015580, W4018218, W4018224, W4018225, W4018226, W4019737, W4019740, W4019741, W4019745, W4020135, W4020136, W4020137, W4020754, W4020976, W4020977, W4021004, W4021005, W4021006, W4021590, W4023842, W4023846, W4024368, W4024375, W4024376, W4025306, W4025333, W4025334, W4025335, W4025336, W4025340, W4025341, W4025346, W4026865, W4026866, W4026871, W4026872, W4026873, W4026877, W4026878, W4028177, W4028178, W4028205, W4028206, W4028837, W4029396, W4029397, W4029398, W4029399, W4029400, W4029401, W4029405, W4029406, W4029407, W4029409, W4029419, W4029420, W4029421, W4029422, W4029423, W4029424, W4029992, W4029996, W4029997, W4031837, W4031838, W4031845, W4031846, W4031847, W4031848, W4031849, W4031850, W4033746, W4033747, W4033748, W4033750, W4033753, W4033754, W4035189, W4035190, W4035191, W4035192, W4035193, W4036657, W4036658, W4036660, W4036662, W4036668, W4036669, W4036670, W4036671, W4036826, W4036830, W4036831, W4036832, W4036837, W4038391, W4038392, W4038393, W4038394, W4038395, W4038396, W4038397, W4038398, W4041010, W4041011, W4041012, W4041013, W4041014, W4041015, W4041765, W4041766, W4041767, W4043627, W4043629, W4043630, W4044772, W4044773, W4045391, W4045392, W4045393, W4046004, W4046280, W4046281, W4046282, W4046283, W4047729, W4047730, W4047731, W4047732, W4049876, W4049877, W4049878, W4049886, W4049898, W4049899, W4051086, W4051771, W4051885, W4052556, W4052557, W4052559, W4054324, W4054325, W4054326, W4054327, W4056458, W4056459, W4056460, W4056461, W4058228, W4058229, W4058231, W4058232, W4058233, W4058236, W4058237, W4059453, W4059454, W4060212, W4060214, W4060216, W4060217, W4060218, W4061436, W4062018, W4062019, W4062634, W4062637, W4062639, W4062640, W4063527, W4063528, W4063530, W4067363, W4067896, W4067907, W4067912, W4069130, W4069135, W4069136, W4069137, W4069138, W4070130, W4070133, W4070713, W4070716, W4071339, W4071344, W4071345, W4071346, W4071347, W4071698, W4071699, W4071700, W4071704, W4071705, W4072883, W4072887, W4072890, W4072891, W4075172, W4075176, W4075179, W4075180, W4075184, W4076673, W4076674, W4076675, W4076676, W4076677, W4076678, W4076679, W4076680, W4076688, W4076689, W4076690, W4076691, W4077443, W4077444, W4077446, W4080720, W4085551, W4085552, W4085553, W4085555, W4085562, W4085563, W4085564, W4085565, W4085566, W4087643, W4087644, W4087645, W4087648, W4088916, W4088917, W4088918, W4088919, W4088920, W4088921, W4088922, W4088923, W4088924, W4090953, W4090957, W4090960, W4090961, W4090962, W4090963, W4090964, W4090965, W4090966, W4092761, W4092762, W4092768, W4092769, W4092770, W4092771, W4092772, W4092773, W4092774, W4095496, W4095499, W4095500, W4095501, W4096105, W4096106, W4096107, W4096108, W4096109, W4096110, W4097793, W4097794, W4097795, W4098221, W4098222, W4098235, W4099949, W4099954, W4099955, W4099956, W4099959, W4099966, W4099967, W4099968, W4099969, W4099970, W4099971, W4101154, W4101155, W4101156, W4101157, W4101158, W4101159, W4101160, W4101161, W4104062, W4104063, W4104066, W4104070, W4104071, W4104075, W4104082, W4104083, W4104084, W4105323, W4105324, W4105329, W4105339, W4105340, W4105870, W4105871, W4106536, W4106538, W4106542, W4106543, W4106544, W4106548, W4106549, W4108506, W4108507, W4108510, W4108514, W4108515, W4109252, W4109254, W4109262, W4109263, W4109264, W4111075, W4111076, W4111077, W4111078, W4111246, W4111252, W4111258, W4111260, W4111261, W4111694, W4111695, W4111696, W4111697, W4114771, W4115988, W4115990, W4115991, W4115995, W4116001, W4116002, W4116003, W4116004, W4116527, W4117693, W4119513, W4119514, W4119515, W4119517, W4119518, W4119686, W4121011, W4121016, W4121026, W4122214, W4122215, W4122216, W4123472, W4123473, W4123476, W4123477, W4124356, W4124357, W4124360, W4125874, W4125879, W4125884, W4125885, W4127547, W4127548, W4129308, W4129309, W4129310, W4129311, W4130716, W4130718, W4130719, W4131791, W4131794, W4131795, W4132491, W4132492, W4132493, W4132496, W4132497, W4132498, W4133114, W4133751, W4133752, W4134801, W4134806, W4135746, W4135751, W4135752, W4136593, W4136594, W4136595, W4137942, W4138480, W4138488, W4138489, W4138490, W4138491, W4139798, W4141323, W4141881, W4141882, W4143475, W4143476, W4143479, W4143480, W4143483, W4144788, W4144789, W4144796, W4144797, W4144798, W4144799, W4144801, W4144802, W4146103, W4147117, W4147120, W4147121, W4147124, W4149077, W4149080, W4149081, W4149656, W4149657, W4149658, W4152950, W4152951, W4152953, W4153610, W4153617, W4153618, W4153622, W4155250, W4155251, W4155252, W4155259, W4155260, W4155261, W4156091, W4156095, W4156096, W4156097, and W4156100.

Where was it sold?

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.

More recalls from Wilson-Cook Medical

All 23

Reported	Class	Recall	Company	Reason	Where
22 Apr 2026Device	CLASS II	Instinct Plus Endoscopic Clipping Device recalled by Wilson-Cook Medical	Wilson-Cook Medical	Device Malfunction	Nationwide
25 Feb 2026Device	CLASS II	Teslatome Bipolar Sphincterotomes recalled by Wilson-Cook Medical	Wilson-Cook Medical	Other	4 states
11 Feb 2026Device	CLASS II	Nasal Jejunal Feeding Tube recalled by Wilson-Cook Medical	Wilson-Cook Medical	Packaging Defects	NC
11 Dec 2024Device	CLASS II	Cook Medical Hemo-7-EU Hemospray Endoscopic Hemostat recalled	Wilson-Cook Medical	Device Malfunction	NC
23 Oct 2024Device	CLASS II	Cook Medical Hemo-7 Hemospray Endoscopic Hemostat recalled	Wilson-Cook Medical	Other	Nationwide

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Other	Nationwide