FDA Device recall Z-0527-2015
Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only
- FDA Device
- Class II
- terminated
- Published 2014-12-17
On 2014-12-17 the FDA classified a Class II recall of Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only by Alcon Research, citing the product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0527-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-11 |
| Published | 2014-12-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Alcon Research |
| Distribution | US |
Product
Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use Straight/Iris Bipolar Forceps REF 8065129501 Sterile RX only. Usage: Electrosurgical instrument for ophthalmic surgery.
Reason
The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers.
Identifiers
| code_info | Lot numbers 061814-95 and 080614-91 |
|---|
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-0527-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.