FDA Device recall Z-1469-2024

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

FDA Device
Class II
ongoing
Published 2024-04-10

On 2024-04-10 the FDA classified a Class II recall of Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS by Covidien, citing the potential for trocar seal disengagement when using mesh products incorrectly with the device.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1469-2024
Classification	Class II
Status	ongoing
Initiated	2024-02-28
Published	2024-04-10
Last updated	2026-09-13 11:57 UTC
Company	Covidien
Distribution	US

Product

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

Reason

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

Identifiers

code_info	Product Number/CFN: OMS-T10BTS; UDI/DI: 20884521081076, 10884521081079; Lot Serial Number: P1D1416, P1E1509, P1F1547, P… 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;

code_info

Product Number/CFN: OMS-T10BTS; UDI/DI: 20884521081076, 10884521081079; Lot Serial Number: P1D1416, P1E1509, P1F1547, P…

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;

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1469-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.