# FDA recall Z-0497-2020

> **Teleflex Medical** · Class II · device recall initiated 2019-10-04.

## 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

## Reason for recall

Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips falling out of the applier, clip breakage, or the jaws becoming locked in a partially closed position (jammed).

## Distribution

Worldwide distribution, including US nationwide (including Puerto Rico).

## Key facts

- **Recall number:** Z-0497-2020
- **Recalling firm:** Teleflex Medical
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-10-04
- **Report date:** 2019-11-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morrisville, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0497-2020

## Citation

> AI Analytics. FDA recall Z-0497-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0497-2020. Source: US FDA. Licensed CC0.

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