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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94131

7 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 28, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Covidien, LP

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

7 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 7

Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB

Z-1465-2024
Recall number
Z-1465-2024
Initiated
February 28, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Covidien, LP
Quantity
124,863 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The potential for trocar seal disengagement when using mesh products incorrectly with the device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product Number/CFN: OMS-T10SB; UDI/DI: 20884521081083 and 10884521081086; Lot Serial Number: P0B1097Y, P0L1408, P0L1408, P0L1442, P0L1442, P0M1720, P0M1721, P0M1931, P1A1469, P1A1469, P1A1470, P1A1485, P1A1486, P1A1486, P1B1294, P1B1294, P1B1449, P1C0441, P1C1565, P1C1565, P1C1566, P1C1568, P1C1674, P1C1674, P1C1675, P1C1676, P1C1676, P1C1786, P1C1920, P1D0366, P1D1379, P1D1379, P1D1380, P1D1380, P1D1509, P1D1509, P1E1551, P1F1389, P1F1482, P1F1482, P1F1521, P1G0143, P1G0143, P1K0808, P1K0808, P1K1036, P1K1099, P1K1099, P1K1320, P1L0482, P1L0482, P1L0486, P1L0486, P1L0679, P1L0679, P1L0680, P1L0680, P1L0885, P1L0885, P1L1108, P1L1109, P1L1109, P1M0032, P1M0032, P1M0033, P1M0033, P2A0611, P2A0611, P2A0612, P2A0612, P2A0613, P2A0613, P2A0614, P2A0615, P2A0615, P2B0280, P2B0280, P2C0455, P2C0456, P2C0457, P2C0745, P2C0745, P2D0324, P2D0325, P2D0325, P2D0326, P2D0327, P2D0352, P2D0352, P2D0353, P2D0353, P2E0013, P2E0013, P2E0014, P2E0014, P2E0076, P2E0077, P2E0077, P2E0078, P2E0352, P2E0447, P2E0448, P2E0449, P2E0449, P2F0136, P2F0136, P2F0137, P2F0137, P2F0138, P2F0139, P2F0139, P2F0384, P2F0384, P2F0455, P2F0455, P2F0456, P2F0456, P2F0457, P2F0457, P2G0324, P2G0324, P2H0044, P2H0273, P2H0307, P2H0414, P2J0025, P2J0083, P2J0286, P2J0455, P2K0149, P2K0440, P2L0090, P2L0091, P2L0091, P2M0031, P3A0237, P3A0238, P3A0239, P3A0240, P3A0240, P3B0308, P3B0443, P3B0444, P3B0444, P3D0349, P3D0350, P3D0350, P3E0080, P3E0080, P3E0371, P3E0458, P3E0458, P3F0043, P3F0043, P3F0044, P3H0831, P3H1177, P3H1177, P3J0865, P3J0865, P3J0944, P3J0944, P3J0945, P3J0945, P3J0946, P3J1063, P3J1064, P3J1131, P3L0678, P3L0679, P3L0820, P3L0821;

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.;

device · product 2 of 7

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

Z-1466-2024
Recall number
Z-1466-2024
Initiated
February 28, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Covidien, LP
Quantity
315,716 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The potential for trocar seal disengagement when using mesh products incorrectly with the device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

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;

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.;

device · product 3 of 7

Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL

Z-1467-2024
Recall number
Z-1467-2024
Initiated
February 28, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Covidien, LP
Quantity
11,796 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The potential for trocar seal disengagement when using mesh products incorrectly with the device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product Number/CFN: OMS-T10BTSNL; UDI/DI: 10884521539648; Lot Serial Number: P0M1930, P1C1684, P1C1685, P1D1418, P1F1548, P1F1549, P1J0729, P1J1343, P1K0356, P1M0969, P2A0779, P2B0758, P2D0021, P2D0022, P2D0023, P2F0324, P2H0410, P2H0411, P2J0053, P2J0456, P2L0093, P2M0416, P2M0417, P3C0354, P3E0462;

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.;

device · product 4 of 7

Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT

Z-1468-2024
Recall number
Z-1468-2024
Initiated
February 28, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Covidien, LP
Quantity
93,673 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The potential for trocar seal disengagement when using mesh products incorrectly with the device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product Number/CFN: OMS-T12BT; UDI/DI: 20884521081090, 10884521081093; Lot Serial Number: P1C1924, P1D0400, P1D0400, P1D1411, P1D1412, P1D1508, P1F1483, P1F1484, P1F1484, P1F1485, P1F1485, P1F1591, P1G0141, P1G0141, P1G1118, P1G1120, P1H0046, P1H0046, P1H0047, P1H0047, P1H0048, P1H0048, P1H0861, P1H0861, P1H0862, P1H0862, P1J0858, P1J0858, P1J0860, P1J0860, P1K0455, P1K0455, P1K0838, P1K1052, P1L0926, P1L0926, P1L0985, P1M0026, P1M0026, P1M0027, P1M0027, P1M0028, P1M0028, P1M0031, P1M0031, P1M0743, P1M0743, P2A0129, P2A0744, P2A0744, P2A0745, P2B0746, P2B0746, P2C0176, P2C0176, P2C0177, P2C0177, P2C0230, P2C0230, P2C0231, P2C0231, P2C0232, P2C0232, P2C0233, P2C0233, P2C0879, P2C0879, P2D0512, P2D0512, P2E0351, P2E0351, P2E0370Q, P2E0664, P2E0664, P2F0486, P2F0486, P2G0305, P2G0305, P2H0086, P2H0086, P2H0087, P2H0148, P2H0148, P2H0308, P2H0409, P2H0415, P2H0415, P2H0579, P2H0579, P2J0008, P2J0008, P2J0082, P2J0082, P2J0458, P2J0459, P2J0459, P2K0081, P2K0081, P2K0124, P2K0124, P2K0435, P2K0435, P2K0566, P2K0566, P2L0565, P2M0162, P2M0163, P2M0163, P2M0164, P2M0164, P2M0269, P2M0269, P2M0270, P2M0270, P2M0271, P2M0271, P2M0274, P2M0274, P3A0164, P3A0164, P3B0074, P3B0263Q, P3B0263Q, P3D0154, P3D0154, P3D0155, P3D0155, P3D0247, P3D0247, P3D0248, P3D0248, P3D0249, P3D0249, P3D0402, P3E0244, P3E0244, P3E0245, P3E0245, P3F0571, P3F0572, P3F0572, P3G0180, P3G0180, P3G0331, P3G0331, P3G0332, P3G0332, P3H0760, P3H0760, P3H0763, P3H0763, P3H0764, P3H1058, P3J1104, P3J1104, P3J1165, P3K1277Q, P3L0884;

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.;

device · product 5 of 7

Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS

Z-1469-2024
Recall number
Z-1469-2024
Initiated
February 28, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Covidien, LP
Quantity
18,048 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The potential for trocar seal disengagement when using mesh products incorrectly with the device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product Number/CFN: OMS-T10BTS; UDI/DI: 20884521081076, 10884521081079; Lot Serial Number: P1D1416, P1E1509, P1F1547, P1H0898, P1J0874, P1J0895, P1J0895, P1J1268, P1J1268, P1J1340, P1J1340, P1J1341, P1K0181, P1L0683, P1L0978, P1L0984, P1L0984, P2A0017, P2A0017, P2A0018, P2A0019, P2A0019, P2A0020, P2A0021, P2A0021, P2A0750, P2A0750, P2B0135, P2B0136, P2B0136, P2B0752, P2B0916, P2C0757, P2D0347, P2D0541, P2D0542, P2F0385, P2F0386, P2F0386, P2H0022, P2H0022, P2H0147, P2H0147, P2K0433, P2K0433, P2K0434, P2K0434, P3D0123, P3D0123, P3D0124, P3D0124, P3E0187, P3E0187, P3E0188, P3E0189, P3E0189, P3H1197, P3J0771, P3J0858, P3K1341;

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.;

device · product 6 of 7

Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT

Z-1470-2024
Recall number
Z-1470-2024
Initiated
February 28, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Covidien, LP
Quantity
165,356 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The potential for trocar seal disengagement when using mesh products incorrectly with the device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product Number/CFN: OMS-T10BT; UDI/DI: 10884521080874, 20884521080871; Lot Serial Number: P1D1353, P1D1353, P1D1355, P1D1409, P1D1410, P1D1506, P1D1506, P1D1507, P1D1507, P1E1402, P1E1402, P1E1403, P1E1403, P1E1505, P1E1505, P1E1506, P1E1506, P1F0061, P1F0061, P1F0062, P1F0062, P1F0063, P1F1018, P1F1018, P1F1019, P1F1388, P1F1388, P1F1546, P1G0140, P1G0140, P1G1117, P1G1117, P1G1119, P1G1119, P1G1121, P1G1121, P1G1364, P1G1364, P1H0049, P1H0049, P1H0421, P1H0527Q, P1H0527Q, P1H0859, P1H0859, P1H0860, P1H0860, P1J1272, P1J1321, P1J1321, P1J1339, P1J1339, P1J1342, P1J1342, P1K0179, P1K0179, P1K0180, P1K0180, P1K0182, P1K0182, P1K0353, P1K0353, P1K0560, P1K0560, P1K0561, P1K0561, P1K0589, P1K0589, P1L0490, P1L0490, P1L0681, P1L0681, P1L0705, P1L0705, P1L0976, P1L0976, P1M0021, P1M0021, P1M0022, P1M0744, P1M0744, P1M0745, P1M0970, P1M0971, P1M1151, P1M1152, P2A0118, P2A0118, P2B0028Q, P2B0137, P2B0137, P2B0139, P2B0139, P2B0308, P2B0745, P2B0745, P2B0912, P2B0912, P2B0913, P2B0913, P2C0175, P2C0175, P2C0178, P2C0643, P2C0643, P2C0758, P2C0758, P2C0764, P2C0765, P2C0765, P2C0877, P2C0877, P2C0878, P2C0878, P2D0231, P2D0231, P2D0232, P2D0232, P2D0373, P2D0373, P2D0374, P2D0374, P2D0415, P2D0415, P2D0539, P2D0539, P2D0540, P2D0540, P2E0244, P2E0244, P2E0245, P2E0371, P2E0371, P2F0041, P2F0041, P2F0042, P2F0133, P2F0133, P2F0134, P2F0134, P2F0135, P2F0135, P2F0449, P2F0449, P2F0450, P2F0450, P2F0451, P2F0451, P2F0452, P2F0452, P2F0453, P2F0453, P2F0454, P2F0454, P2G0141Q, P2G0533, P2G0533, P2H0085, P2H0085, P2H0142, P2H0142, P2H0419, P2H0419, P2H0570, P2H0570, P2J0081, P2J0081, P2J0362, P2J0362, P2J0442, P2J0442, P2J0443, P2J0443, P2J0460, P2J0460, P2K0080, P2K0080, P2K0123, P2K0123, P2K0432, P2K0432, P2K0565, P2K0565, P2L0554, P2L0554, P2L0555, P2L0555, P2L0556, P2L0556, P2M0032, P2M0408, P2M0408, P2M0409, P2M0410, P2M0410, P2M0411, P2M0411, P3A0084, P3A0084, P3A0085, P3A0086, P3A0086, P3A0087, P3A0271, P3A0271, P3A0272, P3A0272, P3A0273, P3A0273, P3A0277, P3A0277, P3A0278, P3A0278, P3A0279, P3A0279, P3B0075, P3B0075, P3B0147, P3B0147, P3B0158, P3B0158, P3B0162Q, P3D0121, P3D0121, P3D0122, P3D0122, P3D0150, P3D0150, P3D0151, P3D0151, P3D0152, P3D0152, P3D0399, P3D0400, P3D0400, P3D0401, P3D0401, P3E0294, P3E0294, P3E0295, P3E0295, P3E0315, P3E0315, P3E0369, P3E0369, P3F0461, P3F0461, P3F0462, P3F0462, P3H1033, P3H1033, P3H1034, P3H1193, P3H1193, P3H1194, P3H1194, P3H1195, P3H1195, P3J0855, P3J0855, P3J0856, P3J0857, P3J0857, P3J1100, P3J1100, P3J1101, P3J1101, P3J1102, P3J1103, P3J1103, P3K0951, P3K1067, P3K1068, P3K1069, P3K1243, P3K1244, P3K1339, P3K1340, P3L0889, P3L0890;

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.;

device · product 7 of 7

Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL

Z-1471-2024
Recall number
Z-1471-2024
Initiated
February 28, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Covidien, LP
Quantity
44,777 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The potential for trocar seal disengagement when using mesh products incorrectly with the device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product Number/CFN: OMS-T12BTNL; UDI/DI: 20884521552446, 10884521552449; Lot Serial Number: P0L1444, P0L1444, P0M1932, P0M1932, P1A1491, P1A1491, P1B0649, P1B0649, P1B1560, P1B1560, P1D0399, P1D0399, P1G0142, P1G0142, P1G1132, P1G1132, P1G1365, P1J1046, P1J1179, P1J1179, P1J1213, P1J1213, P1L0002, P1M0637, P1M0637, P1M0838, P1M0838, P2A0608, P2A0608, P2B0747, P2B0747, P2B0981, P2B0982, P2B0982, P2C0229, P2C0229, P2C0690, P2C0710, P2C0710, P2F0161, P2G0536, P2G0536, P2G0537, P2G0537, P2H0423, P2J0274, P2J0274, P2J0283, P2J0283, P2K0193, P2K0193, P2K0567, P2M0165, P2M0165, P2M0276, P2M0276, P3A0094, P3B0040, P3B0041, P3B0520, P3B0520, P3D0250, P3D0250, P3E0457, P3F0078, P3F0573, P3G0330, P3G0330, P3H1178, P3H1261, P3J1164;

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.;