WECK AutoEndo5 — Class II medical device recall Z-0496-2020
Ongoing recall by Teleflex Medical, reported 2019-11-27, distributed nationwide. Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a di
| Recall number | Z-0496-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Morrisville, NC, United States |
| Recall initiated | 2019-10-04 |
| Classified | 2019-11-19 |
| Reported by FDA | 2019-11-27 |
| Distributed | Nationwide (US) |
| Quantity | 34,491 devices |
| Reason classes | device malfunction |
| Model numbers | AE05ML |
Product
WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML 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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0496-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.