Agency classClass IIOur severity:High FDA (Devices)·Z-1465-2024·Announced 2024-04-10

Covidien Auto Suture Trocar Recalled for Potential Seal Disengagement

Covidien is recalling approximately 124,863 Auto Suture Structural Balloon Trocars worldwide due to potential seal disengagement when used incorrectly with mesh products.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall for surgical trocars with potential for seal disengagement that could compromise surgical procedures. No injuries or deaths have been reported. Per the rubric, risk-of-harm products without reported injury are classified as High (3).

Plain-English summary

Covidien, LP is recalling the Auto Suture Structural Balloon Trocar (Product Number OMS-T10SB). Approximately 124,863 units are affected by this Class II recall, with specific lot serial numbers ranging from P0B1097Y through P3L0821.

The recall addresses a potential for trocar seal disengagement when mesh products are used incorrectly with the device. This issue may occur during surgical procedures.

The affected trocars have been distributed worldwide, including throughout the United States and to more than 50 countries including Canada, United Kingdom, Australia, Japan, and Germany. Healthcare facilities using these devices should identify affected units by product number and lot serial numbers.

Patients and healthcare providers should contact Covidien, LP if they have questions about these devices or have experienced issues with seal disengagement.

The recalled product

Product: Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB
Manufacturer: Covidien, LP
Category: Medical Device — Surgical Instruments
Hazard: seal-disengagement
Affected units: 124,863

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Product Number/CFN: OMS-T10SB
UDI/DI: 20884521081083 and 10884521081086
Lot Serial Number: P0B1097Y
P0L1408
P0L1442
P0M1720
P0M1721
P0M1931
P1A1469
P1A1470
P1A1485
P1A1486
P1B1294
P1B1449
P1C0441
P1C1565
P1C1566
P1C1568
P1C1674
P1C1675

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Covidien, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Same manufacturer · Covidien, LP

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Same hazard · seal disengagement