The Recall Desk

FDA (Devices) recall action 84032

Teleflex Medical recalled 2 products on 2019-11-27

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2019-11-27
Critical
0
Units
38,590

Why these products were recalled

Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips falling out of the applier, clip breakage, or the jaws becoming locked in a partially closed position (jammed).

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2019-11-27

    Teleflex Recalls Hem-O-Lok AutoEndo5 Clip Appliers Due to Jamming

    Teleflex Medical is recalling 4,099 Hem-O-Lok AutoEndo5 clip appliers because they may jam or misload, potentially causing clips to fall out or break during surgery.

    Product
    WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965 Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2019-11-27

    Teleflex Recalls WECK AutoEndo5 Clip Appliers Due to Jamming Risk

    Teleflex Medical is recalling WECK AutoEndo5 clip appliers because a component discrepancy may cause jamming or misloading, leading to clip failure during surgery.

    Product
    WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips
    Category
    Distribution
    1 state