Auto Endo5 Hem-o-lok Automatic Clip Applier — Class II medical device recall Z-0886-2016
Terminated recall by Teleflex Medical, reported 2016-03-02, distributed in CA, MI, NC, PA, TX, VA. The clip in the applier may be missing a boss. A boss is the part of the clip that is used to hold the clip wi
| Recall number | Z-0886-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Research Triangle Park, NC, United States |
| Recall initiated | 2016-02-02 |
| Classified | 2016-02-25 |
| Reported by FDA | 2016-03-02 |
| Terminated | 2017-08-11 |
| Distributed | CA, MI, NC, PA, TX, VA |
| Countries outside the US | BE, CA, KR |
| Quantity | 543 units |
| Model numbers | 543965 |
Product
Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only, Sterile, REF 543965 Product Usage: The Weck Auto Endo5 hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips. These appliers are designed for use with 5/5.5mm cannulas. Hem-o-lok Ligating Clips are intended for use in procedures involving ligation of vessels or tissue structures.
Reason for recall
The clip in the applier may be missing a boss. A boss is the part of the clip that is used to hold the clip within the applier jaws prior to application.
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-0886-2016. 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.