Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101… — Class II medical device recall Z-0527-2015
Terminated recall by Alcon Research, Ltd., reported 2014-12-17, distributed nationwide. The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to c
| Recall number | Z-0527-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research, Ltd., Fort Worth, TX, United States |
| Recall initiated | 2014-11-11 |
| Classified | 2014-12-08 |
| Reported by FDA | 2014-12-17 |
| Terminated | 2016-02-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CH, ID, PK, ZA |
| Quantity | 2,321 |
| Reason classes | labeling |
| Lot numbers | 061814-95, 080614-91 |
| Model numbers | 8065129101, 8065129501 |
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 for recall
The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers.
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-0527-2015. 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.