Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with… — Class III medical device recall Z-0560-2014
Terminated recall by Edwards Lifesciences, LLC, reported 2014-01-01, distributed in FL. Edwards Lifesciences is recalling one lot of Ergonic instrument due to mislabeling. Ergonic scissors standard
| Recall number | Z-0560-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Draper, UT, United States |
| Recall initiated | 2013-11-20 |
| Classified | 2013-12-21 |
| Reported by FDA | 2014-01-01 |
| Terminated | 2014-02-10 |
| Distributed | FL |
| Quantity | 3 |
| Reason classes | labeling |
| Lot numbers | 11211566.1 |
| Model numbers | ERGF01330 |
| Expiration dates | 2017-09-01 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0560-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.