Agency classClass IIOur severity:High FDA (Devices)·Z-1470-2024·Announced 2024-04-10

Covidien Auto Suture Blunt Tip Trocar Seal Disengagement Recall

Covidien Auto Suture Blunt Tip Trocar units may experience seal disengagement when mesh products are used incorrectly with the device. Healthcare facilities should discontinue use of affected units and contact Covidien for guidance.

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 an FDA Class II medical device recall with no reported incidents or injuries mentioned in the source material. However, trocar seal disengagement during surgical use represents a risk-of-harm scenario with potential for significant patient injury, meeting the threshold for a High severity rating.

Plain-English summary

Covidien, LP is recalling 165,356 units of the Covidien Auto Suture™ Blunt Tip Trocar (Product Number OMS-T10BT) due to the potential for trocar seal disengagement when mesh products are used incorrectly with the device.

This potential disengagement creates a risk for patients and medical professionals during surgical procedures. The vulnerability may affect the proper function of the trocar during surgical use with mesh products.

The affected units were distributed worldwide, including throughout the United States and numerous international countries. Multiple lot numbers are involved in this recall. Healthcare facilities should identify and secure any affected units from their inventory.

If you have the affected Covidien Auto Suture Blunt Tip Trocar units, stop using them immediately. Contact Covidien, LP for instructions on how to return, replace, or properly dispose of the affected devices. Healthcare providers should verify their lot numbers against the recall information to identify affected inventory.

The recalled product

Product: Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT
Manufacturer: Covidien, LP
Category: Medical Device — Surgical Instrument
Hazard: seal-disengagement
surgical-device-defect
Affected units: 165,356

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-T10BT
UDI/DI: 10884521080874
20884521080871
Lot Serial Number: P1D1353
P1D1353
P1D1355
P1D1409
P1D1410
P1D1506
P1D1507
P1E1402
P1E1403
P1E1505
P1E1506
P1F0061
P1F0062
P1F0063
P1F1018
P1F1019
P1F1388

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