Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap… — Class II medical device recall Z-0479-2014
Terminated recall by Aesculap, Inc., reported 2013-12-18, distributed nationwide. Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop aft
| Recall number | Z-0479-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap, Inc., Center Valley, PA, United States |
| Recall initiated | 2013-09-10 |
| Classified | 2013-12-10 |
| Reported by FDA | 2013-12-18 |
| Terminated | 2014-10-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, DE, JP, TW |
| Quantity | 85 |
Product
Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in neurosurgery, ENT surgery, urology, laparoscopy, and plastic surgery.
Reason for recall
Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop after release of the foot control.
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-0479-2014. 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.