Wilson-Cook Medical Inc.: Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.

Recall number

Z-1132-2019

Recalling firm

Wilson-Cook Medical Inc.

Product

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

Status

Terminated

Initiated

2019-01-04

Posted

not on file

Terminated

2020-07-21

Reason

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

Root cause

Nonconforming Material/Component

Action

The firm, Cook Medical, sent an"URGENT: MEDICAL DEVICE RECALL" letter to its customers. The letter described the product, problem and actions to be taken. The customer were instructed to do the following: 1. Review the labels of impacted product shipped to your account and quarantine any affected product that remains unused. If you are a distributor and the products have been distributed, contact your customer(s) and direct them to quarantine any affected product. 2. Immediately collect and return all unused affected products at one time to Cook Medical as soon as possible. Affected product should be returned to: Cook Medical Attn: Return Goods Department 053-R 400 Daniels Way Bloomington, IN 47404 3. Complete the attached Recall Return Response form and send to Cook Medical. This form may be sent via fax using the fax number: 812-339-7316 or scanned and emailed to FieldActionsNA@CookMedical.com. Account credit will be issued to your facility upon receipt of this form with the completed information. Should you have any questions, please contact the Customer Relations Department at Cook Medical for more information. Please use FieldActionsNA@CookMedical.com, or call us toll free 1-800-457-4500, press 4, then enter extension 15-2146. Monday through Friday, 8:00AM to 4:30PM, Eastern Time.

Quantity

34,456 units

Distribution

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.

Lot, serial or model codes

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.

510(k) numbers

["K851958"]

PMA numbers

not on file

Product code

KNS

Firm FEI

1037905

Firm city

Winston Salem

Firm state

NC

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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