CLASS II ONGOING Device recall · Reported 10 Apr 2024 · FDA Enforcement Report

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

Covidien is recalling Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL, distributed nationwide in the US. The recall was initiated on 28 Feb 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct 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;

Quantity recalled315,716 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-1466-2024
FDA event ID: 94131
Recalling firm: Covidien, North Haven, CT
Classification: Class II
Status: Ongoing
Recall initiated: 28 Feb 2024
FDA classified: 3 Apr 2024
Reported: 10 Apr 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Surgical Instruments

Timeline

28 Feb 2024	Recall initiated by company
3 Apr 2024	Classified by FDA	+35 days
10 Apr 2024	Published in enforcement report	+7 days

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

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

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.;

Nationwide Puerto Rico

Questions about this recall

Is Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL recalled?

Yes. Covidien recalled Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL on 28 Feb 2024. The recall is Class II and its status is Ongoing. Recall number Z-1466-2024.

Why was it recalled?

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

Which lots are affected?

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;

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 21 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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