Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic...
FDA Device Recall #Z-1132-2019 — Class II — January 4, 2019
Recall Summary
| Recall Number | Z-1132-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 4, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Wilson-Cook Medical Inc. |
| Location | Winston Salem, NC |
| Product Type | Devices |
| Quantity | 34,456 units |
Product Description
Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.
Reason for Recall
Complaints of the snare loop not completely retracting and/or misshaping of the snare loop.
Distribution Pattern
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 / Code Information
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.
Other Recalls from Wilson-Cook Medical Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1362-2026 | Class II | Teslatome Bipolar Sphincterotomes REF: TESLA-B... | Dec 18, 2025 |
| Z-1298-2026 | Class II | Product Name: Nasal Jejunal Feeding Tube REF:... | Dec 15, 2025 |
| Z-0582-2025 | Class II | Cook Medical HEMO-7-EU Hemospray Endoscopic Hem... | Oct 31, 2024 |
| Z-0036-2025 | Class II | Cook Medical Hemo-7 Hemospray Endoscopic Hemost... | Aug 29, 2024 |
| Z-0460-2024 | Class II | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6... | Nov 3, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.