HEALON EndoCoat PRO — Class II medical device recall Z-3064-2026
Ongoing recall by Johnson & Johnson Surgical Vision, Inc., reported 2026-09-09, distributed nationwide. Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures
| Recall number | Z-3064-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Johnson & Johnson Surgical Vision, Inc., Irvine, CA, United States |
| Recall initiated | 2026-07-31 |
| Classified | 2026-08-31 |
| Reported by FDA | 2026-09-09 |
| Distributed | Nationwide (US) |
| Quantity | 111,478 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 05050474755093, 05050474755109, 05050474755116, 05050474755123 |
| Lot numbers | 10300012/5050474755093/UA32232, 10300016/5050474755116/UA32447, 10301012/5050474755109/UB33014, 10301016/5050474755123/UB33084, UA32250, UA32268, UA32290, UA32292, UA32303, UA32371, UA32448, UA32449, UB33008, UB33026, UB33041, UB33057, UB33060, UB33082, UB33083, UB33100, UB33175, UB33190, UB33194, UP31203, UP31205 |
| Model numbers | 10300012, 10300016, 10301012, 10301016 |
Product
HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON EndoCoat PRO, REF: 10301012 (EU); HEALON DUET PRO II, REF: 10301016 (EU)
Reason for recall
Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, withdraw cannula and reassess the insertion conditions (i.e. insertion angle, incision size, etc.) before proceeding because forcing the cannula may cause corneal abrasion, iris trauma or descemet's membrane detachment.
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-3064-2026. 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.