Agency classClass IIOur severity:High FDA (Devices)·Z-0497-2020·Announced 2019-11-27

Teleflex Recalls Hem-O-Lok AutoEndo5 Clip Appliers Due to Jamming

Teleflex Medical is recalling 4,099 Hem-O-Lok AutoEndo5 clip appliers because they may jam or misload, potentially causing clips to fall out or break during surgery.

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, and the hazard involves a surgical device malfunction (jamming/misloading) that poses a risk of harm during procedures, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Teleflex Medical is recalling 4,099 units of the WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopic Hem-o-lok Applier (REF 543965). These devices are used to deliver non-absorbable polymer ligating clips during endoscopic surgical procedures. The recall covers devices distributed worldwide, including the United States and Puerto Rico.

The recall was initiated because certain clip appliers have an increased rate of misloading and jamming complaints. This issue may be caused by a discrepancy in the specification of a component. When the applier jams or misloads, it can result in clips falling out of the device, clip breakage, or the jaws becoming locked in a partially closed position.

Healthcare facilities and providers who have used or possess these devices should stop using them and contact Teleflex Medical for further instructions. The specific lot codes affected are listed in the official FDA recall record Z-0497-2020.

The recalled product

Product: WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965 Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips
Manufacturer: Teleflex Medical
Category: Medical Device — Surgical Instrument
Hazard: device-malfunction
jamming
misloading
Affected units: 4,099

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Teleflex Medical 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 2 products in this recall →

Same manufacturer · Teleflex Medical

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Same hazard · device malfunction