CLASS II Device recall · Reported 2 Mar 2016 · FDA Enforcement Report
Auto Endo5 Hem-o-lok Automatic Clip Applier recalled by Teleflex Medical
Teleflex Medical is recalling Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, distributed in California, Michigan, North Carolina, Pennsylvania, Texas, Virginia. The recall was initiated on 2 Feb 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0886-2016
- FDA event ID
- 73181
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Feb 2016
- FDA classified
- 25 Feb 2016
- Reported
- 2 Mar 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 2 Feb 2016 | Recall initiated by company | |
| 25 Feb 2016 | Classified by FDA | +23 days |
| 2 Mar 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution in the state of CA, MI, NC, PA, TX, VA, and the countries of Canada, Korea & Belgium
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
73J1500065, 73J1500066, 73J1500280, 73J1500440, 73J1500565, 73J1500566, 73K1500193
Where was it sold?
Worldwide Distribution in the state of CA, MI, NC, PA, TX, VA, and the countries of Canada, Korea & Belgium
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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