Z-0886-2016Class II

Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only, Sterile, REF 543965

Name: Z-0886-2016 Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only, Sterile, REF 543965
Creator: Teleflex Medical
Published: 2016-02-02
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2016-02-02 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical began a recall of 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... on 2016-02-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0886-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-02
Posted: 2016-02-25
Terminated: 2017-08-11
Recalling firm: Teleflex Medical
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.
Product code: FZP Clip, Implantable
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Teleflex sent an Urgent Medical Device Recall Notification letter dated February 2, 2016 to customers. The letter identified the affected product, problem and actions to be taken. A separate letter was sent to distributors advising them to conduct a sub-recall. Customers were instructed to: 1. If you have affected stock, immediately discontinue use and quarantine any products with the catalog numbers listed in the letter. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1- 855-419-8507, Attn: Customer Service or email to [email protected] will document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will document receipt of the letter. For questions contact your local sales representative or Customer Service at 1-866-246-6990
Quantity in commerce: 543 ea.
Distribution: Worldwide Distribution in the state of CA, MI, NC, PA, TX, VA, and the countries of Canada, Korea & Belgium
Product codes and lots: 73J1500065, 73J1500066, 73J1500280, 73J1500440, 73J1500565, 73J1500566, 73K1500193

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0886-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0886-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25

Product code FZP

K142777Class IIWeck Hem-o-lok Auto Endo5 Ligating Clip ApplierTeleflexmedical, Inc. / cleared 2014-12-19

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)