FDA Device recall Z-0560-2014
Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip
- FDA Device
- Class III
- terminated
- Published 2014-01-01
On 2014-01-01 the FDA classified a Class III recall of Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip by Edwards Lifesciences, citing 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 con….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0560-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-11-20 |
| Published | 2014-01-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Edwards Lifesciences |
| Distribution | FL |
Product
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.
Reason
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.
Identifiers
| code_info | Lot Number: 11211566.1, Exp. Date: 09/01/2017. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0560-2014%22
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