Agency classClass IIOur severity:High FDA (Devices)·Z-1211-2019·Announced 2019-05-01

Covidien Endo Clinch II Auto Suture Grasper Recalled for Sterilization Issues

COVIDIEN LLC is recalling 7,248 units of the Endo Clinch II Auto Suture Grasper because the sterilization method used was not consistent with the labeling and approved method.

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: The recall is classified as FDA Class II. The hazard involves a deviation from the approved sterilization method for a medical device, which presents a risk of harm, but the source text does not report specific injuries or illnesses, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

COVIDIEN LLC is recalling 7,248 units of the Endo Clinch II Auto Suture Grasper, 5mm (REF: 174317). The recall was initiated because the sterilization method used for these devices was not consistent with the labeling and the approved sterilization method.

The affected devices have a 5 mm diameter, rotating, insulated shaft approximately 31 cm in length and are designed for introduction and use through the appropriately sized Covidien trocar sleeve or larger sized sleeve with the use of a converter. The atraumatic jaws are clamped and locked onto tissue structures by closing the handles.

The recall affects worldwide distribution, including the United States (Nationwide) and Canada, Chile, Costa Rica, Guatemala, Japan, Mexico, Panama, Slovakia, Spain, Switzerland, and Turkey. Specific lot numbers involved include P8D1333PRX, P8D1334PRX, P8D1614PRX, P8D1615PRX, P8D1616PRX, P8E1143PRX, P8E1189PRX, P8E1269PRX, P8E1271PRX, P8E1272PRX, P8F0008PRX, P8F1238PRX, P8F1239PRX, P8F1307PRX, P8F1448PRX, P8F1452PRX, P8F1480PRX, and P8F1545PRX.

The recalled product

Product: Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rotating, insulated shaft approximately 31 cm in length and is designed for introduction and use through the appropriately sized…
Manufacturer: COVIDIEN LLC
Category: Medical Device — Surgical Instrument
Hazard: sterilization-defect
Affected units: 7,248

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by COVIDIEN LLC 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 3 products in this recall →

Same manufacturer · COVIDIEN LLC

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Same hazard · sterilization defect