Hem-o-lok Large Polymer Ligating Clips — Class II medical device recall Z-0078-2013
Terminated recall by Teleflex Medical, reported 2012-10-24, distributed nationwide. Product is being recalled due to the possibility that the tray may contain pinholes, compromising product ster
| Recall number | Z-0078-2013 |
|---|---|
| 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 | 2012-09-25 |
| Classified | 2012-10-18 |
| Reported by FDA | 2012-10-24 |
| Terminated | 2012-11-08 |
| Distributed | Nationwide (US) |
| Quantity | 126 units |
| Reason classes | sterility |
| Lot numbers | 01E1200585 |
| Model numbers | 544240 |
Product
Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Teleflex Medical, Research Triangle Park, NC 27709. Teleflex Medicals Hem-o-lok polymer ligating clips are single use, sterile, non-absorbable medial devices that have been designed to ligate vessels and tissue structures during various types of surgical procedures. Vessels and tissue structures in the range of 0.5 to 16 mm can be effectively ligated with Hem-o-lok clips.
Reason for recall
Product is being recalled due to the possibility that the tray may contain pinholes, compromising product sterility.
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-0078-2013. 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.