Edwards Lifesciences, LLC: Medical Device Recall in 2014 - (Recall #: Z-0560-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model Number ERGF01330. The Edwards Surgical Instruments are designed to perform specialized functions in specific cardiac surgical or endoscopic procedures.

Product Classification:

Class III

Date Initiated: November 20, 2013

Date Posted: January 1, 2014

Recall Number: Z-0560-2014

Event ID: 66934

Reason for Recall:

Edwards Lifesciences is recalling one lot of Ergonic instrument due to mislabeling. Ergonic scissors standard curved labeled as a Double Acting DeBakey forcep. Edwards control confirmed that the laser etching on the device was incorrect.

Status: Terminated

Product Quantity: 3

Code Information:

Lot Number: 11211566.1, Exp. Date: 09/01/2017.

Distribution Pattern:

Distributed to 3 customers in FL only.

Voluntary or Mandated:

Voluntary: Firm initiated