Z-1466-2024 Class II Ongoing

Recalled by Covidien, LP — North Haven, CT

FDA device recall Z-1466-2024 was initiated by Covidien, LP on Feb 28, 2024 and is designated Class II. Reason for recall: The potential for trocar seal disengagement when using mesh products incorrectly with the device. The recall status is ongoing. Affected quantity: 315,716 units.

Recall Details

Product Type
Devices
Report Date
Apr 10, 2024
Initiation Date
Feb 28, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
315,716 units

Product Description

Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL

Reason for Recall

The potential for trocar seal disengagement when using mesh products incorrectly with the device.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Aruba, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Gibraltar, Greece, Guadeloupe, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Republic Of, Luxembourg, Macao, Malaysia, Malta, Martinique, Mayotte, Mexico, Netherlands, New Caledonia, New Zealand, Nigeria, Northern Ireland, Norway, Oman, Poland, Portugal, Puerto Rico, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Turkey, United Arab Emirates, United Kingdom, United States, Uzbekistan, Viet Nam, Virgin Islands, U.S.;

Code Information

Product Number/CFN: OMS-T10BTNL; UDI/DI: 20884521527383, 10884521527386; Lot Serial Number: P0L1440, P0L1441, P0M1916, P0M1916, P0M1941, P1A1541, P1A1541, P1C0413, P1C0413, P1C0414, P1C0414, P1C0415, P1C0415, P1C1569, P1C1570, P1C1669, P1C1669, P1C1670, P1C1670, P1C1671, P1C1672, P1C1792, P1C1793, P1C1793, P1C1921, P1C1922, P1C1923, P1D0373, P1D0373, P1D0374, P1D0374, P1D0398, P1D1350, P1D1351, P1D1351, P1D1352, P1D1413, P1D1414, P1D1422, P1D1423, P1D1423, P1D1424, P1D1510, P1D1511, P1D1511, P1E1311, P1E1379, P1E1379, P1E1380, P1E1381, P1E1382, P1E1382, P1E1383, P1E1383, P1E1507, P1E1508, P1F1020, P1F1020, P1F1021, P1F1021, P1F1022, P1F1390, P1F1390, P1F1522, P1F1522, P1F1523, P1F1524, P1G0146, P1G0146, P1G0158, P1G0158, P1G0159, P1G1114, P1G1115, P1G1116, P1G1116, P1G1122, P1G1133, P1G1134, P1G1366, P1G1367, P1H0054, P1H0054, P1H0055, P1H0056, P1H0057, P1H1296, P1H1296, P1H1297, P1H1298, P1H1298, P1J0662, P1J0664, P1J0664, P1J0727, P1J0727, P1J0896, P1J0896, P1J1260, P1J1260, P1J1261, P1J1261, P1J1273, P1J1274, P1J1344, P1J1345, P1K0354, P1K0354, P1K0355, P1K0359, P1K0359, P1K0456, P1K0456, P1K0471, P1K0471, P1K0507, P1K0507, P1L0924, P1L0925, P1M0061, P1M0062, P1M0063, P1M0067, P1M0067, P1M0068, P1M0635, P1M0636, P1M0835, P1M0837, P1M0967, P1M0968, P2A0013, P2A0014, P2A0015, P2A0016, P2A0609, P2A0610, P2A0780, P2B0134, P2B0134, P2B0534, P2B0535, P2B0535, P2B0564, P2B0564, P2B0566, P2B0566, P2B0748, P2B0748, P2B0749, P2B0988, P2C0184, P2C0184, P2C0185, P2C0186, P2C0225, P2C0225, P2C0226, P2C0226, P2C0227, P2C0227, P2C0228, P2C0228, P2C0684, P2C0766, P2C0766, P2C0767, P2C0768, P2C0880, P2C0881, P2D0034, P2D0034, P2D0035, P2D0035, P2D0036, P2D0036, P2D0037, P2D0348, P2D0348, P2D0349, P2D0733, P2D0734, P2D0735, P2F0140, P2F0141, P2F0487, P2F0495, P2F0496, P2F0496, P2F0497, P2F0498, P2F0499, P2F0499, P2G0266, P2G0534, P2G0534, P2G0535, P2G0535, P2H0040, P2H0040, P2H0041, P2H0042, P2H0042, P2H0043, P2H0043, P2H0143, P2H0143, P2H0144, P2H0144, P2H0145, P2H0146, P2H0146, P2H0412, P2H0412, P2H0413, P2H0425, P2H0426, P2H0426, P2H0582, P2H0585, P2H0586, P2J0026, P2J0027, P2J0028, P2J0028, P2J0029, P2J0030, P2J0030, P2J0084, P2J0084, P2J0085, P2J0085, P2J0086, P2J0287, P2J0287, P2J0288, P2J0330, P2J0330, P2J0444, P2J0444, P2J0445, P2J0451, P2J0451, P2J0452, P2J0453, P2J0453, P2J0454, P2K0129, P2K0129, P2K0130, P2K0130, P2K0150, P2K0381, P2K0382, P2K0383, P2K0436, P2K0437, P2K0438, P2K0439, P2K0445, P2K0445, P2K0446, P2K0446, P2K0568, P2K0568, P2K0569, P2L0094, P2L0099, P2L0100, P2L0108, P2L0264, P2L0268, P2L0416, P2L0416, P2L0417, P2L0417, P2L0418, P2L0420, P2L0421, P2L0422, P2L0423, P2L0423, P2L0424, P2L0424, P2L0425, P2L0426, P2M0028, P2M0029, P2M0030, P2M0275, P2M0421, P3A0206, P3A0241, P3A0241, P3A0242, P3B0042, P3B0042, P3B0072, P3B0232, P3B0233, P3B0233, P3B0234, P3B0309, P3B0310, P3B0440, P3B0440, P3B0441, P3B0442, P3B0518, P3B0519, P3C0315, P3C0316, P3C0342, P3C0475, P3C0476, P3C0477, P3C0516, P3C0517, P3D0252, P3D0252, P3D0253, P3D0345, P3D0345, P3D0346, P3D0346, P3D0347, P3D0347, P3D0348, P3D0348, P3E0372, P3F0070, P3F0071, P3F0072, P3F0247, P3F0247, P3F0248, P3F0574, P3F0574, P3F0575, P3F0575, P3H0832, P3H0833, P3H0834, P3H0835, P3H0835, P3H0836, P3H0837, P3H0837, P3H0838, P3H1101, P3H1102, P3H1103, P3H1103, P3H1174, P3H1175, P3H1176, P3J0866, P3J0867, P3J0867, P3J0947, P3J0947, P3J0948, P3J0948, P3K0949, P3K0950, P3K1064, P3K1064, P3K1065, P3K1065, P3K1260, P3K1260, P3K1261, P3K1355, P3K1356, P3K1356, P3K1357, P3K1358, P3K1358, P3L0675, P3L0891, P3L0892;

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-1466-2024
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 24, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.