Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT
FDA Device Recall #Z-1468-2024 — Class II — February 28, 2024
Recall Summary
| Recall Number | Z-1468-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 28, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Covidien, LP |
| Location | North Haven, CT |
| Product Type | Devices |
| Quantity | 93,673 units |
Product Description
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT
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.;
Lot / 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;
Other Recalls from Covidien, LP
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2281-2026 | Class II | Covidien EndoStitch" Polysorb Single Use Loadin... | Apr 15, 2026 |
| Z-0485-2026 | Class II | Covidien Signia" Small Diameter Curved Tip Inte... | Sep 25, 2025 |
| Z-0486-2026 | Class II | Covidien Signia" Small Diameter Curved Tip Inte... | Sep 25, 2025 |
| Z-1891-2024 | Class II | Tri-Staple 2.0 Black Reinforced Intelligent Rel... | Apr 15, 2024 |
| Z-1467-2024 | Class II | Covidien Auto Suture" Blunt Tip Trocar, Product... | Feb 28, 2024 |
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.