Accurus 2500 Standalone Vitreous Probe REF 8065741018 — Class II medical device recall Z-1940-2015
Terminated recall by Alcon Research, Ltd., reported 2015-07-08, distributed nationwide. Insufficient seal on the outside packaging, potentially affecting the sterility of the product.
| Recall number | Z-1940-2015 |
|---|---|
| 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 | 2015-06-02 |
| Classified | 2015-06-29 |
| Reported by FDA | 2015-07-08 |
| Terminated | 2017-04-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BR, CA, CH, CL, CN, CO, CZ, DE, ES, FR, GB, HK, HU, IN, IT, JP, KE, KR, LK, MA, MX, MY, NL, NZ, PL, RU, TH, TR, TW |
| Quantity | 35,475 units |
| Reason classes | sterility, packaging |
| Lot numbers | 14010428X, 14010429X, 14010430X, 14012984X, 14012985X, 14012987X, 14014736X, 14014737X, 14014738X, 14014739X, 14016477X, 14016577X, 14017451X, 14017452X, 14017912X, 14018320X, 14020246X, 14020280X, 14020282X, 14020283X, 14022920X, 14022921X, 14022922X, 14022923X, 14024168X, 14024219X, 14026030X, 14026031X, 14026032X, 14026034X, 14028440X, 14028553X, 14028554X, 14028555X, 14029477X, 14031263X, 14031264X, 14033830X, 14033831X, 14033832X and 3 more |
| Model numbers | 8065741018, 8065750821, 8065751122, 8065803650 |
| Expiration dates | 2014-01-14, 2017-01-14, 2017-02-17, 2017-03-11, 2017-03-26, 2017-04-15, 2017-04-27, 2017-05-21, 2017-06-19, 2017-06-22, 2017-07-27, 2017-08-06, 2017-08-12, 2017-08-26, 2017-09-22, 2017-10-14, 2017-10-15, 2017-11-16, 2017-11-17 |
Product
Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus 25+ 2500 CPM Standalone Vitreous Probe REF 8065751122; Anterior Accurus Probe with Infusion Needle REF 8065803650; Single Use Sterile Probes Rx only. Intended to provide the surgeon with a single-use probe for performing vitrectomy surgical procedures while using the Alcon Accurus vitrectomy console.
Reason for recall
Insufficient seal on the outside packaging, potentially affecting the sterility of the product.
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-1940-2015. 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.