Food, drugs, devices › Teleflex Medical
Device recall: WECK¿ Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11 (28cm), R
FDA enforcement event 75020 is a device recall by Teleflex Medical of Research Triangle Park, NC, initiated 24 Aug 2016 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 25 Aug 2017. Initiation: voluntary: firm initiated. Teleflex Medical has 82 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Teleflex Medical, Research Triangle Park, NC.
Reason for recall
"Misbranded: Incorrect etching on the device."
Distribution
"Worldwide Distribution US Nationwide in the states of FL, IL, KY, MI, NY and OK and countries of Mexico and Canada."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2759-2016 | WECK¿ Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11 (28cm), Rx Only, REF 337111, Product Usage: Weck Closure Systems applier has been designed and calibrated for use with specific Horizon, Hemoclip Plus Hemoclip Traditional, or Atrauclip ligating clips as… | 49 units | Class II | Terminated | 14 Sep 2016 |
Context
Other enforcement events for Teleflex Medical
All 82 events for Teleflex Medical
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Misbranded: Incorrect etching on the device."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution US Nationwide in the states of FL, IL, KY, MI, NY and OK and countries of Mexico and Canada."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 25 Aug 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.