Z-0031-05

Hem-o-lok Endo5 Ligation Applier

Name: Z-0031-05 Hem-o-lok Endo5 Ligation Applier
Creator: Weck
Published: 2004-08-18
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2004-08-18 / Terminated

FDA source

Weck began a recall of Hem-o-lok Endo5 Ligation Applier on 2004-08-18. The reason FDA records is "The jaws may break during clip loading or clip application". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0031-05
Status: Terminated
Initiated: 2004-08-18
Posted: 2004-10-22
Terminated: 2005-01-31
Recalling firm: Teleflex Medical
Product: Hem-o-lok Endo5 Ligation Applier
Product code: HBT Applier, Hemostatic Clip
Reason for recall: The jaws may break during clip loading or clip application.
FDA root cause: Other
Action: Consignees were notified via Federal Express (Domestic) and by email (International and Weck Sales Representatives).
Quantity in commerce: 119 units
Distribution: Nationwide; Australia, Buenos Aires, Canada, France, Korea, New Zealand, Singapore.
Product codes and lots: Catalog number 544965, Lot 943704, 943705, 954592

Product code HBT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)