HEALON EndoCoat PRO: recall status

Notice names this product. Johnson & Johnson Surgical Vision’s HEALON EndoCoat PRO is named in FDA Class II recall Z-3064-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: 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. Identifying details: REF/UDI-DI/Lot: 10300012/5050474755093/UA32232, UA32250, UA32268, UA32290, UA32292, UA32303, UA32371, UP31203, UP31205; 10300016/5050474755116/UA32447, UA32448, UA32449, UB33008, UB33026, UB33082, UB33083, UB33175; 10301012/5050474755109/UB33014, UB33041, UB33057, UB33060, UB33100, UB33190; 10301016/5050474755123/UB33084, UB33194. Units affected: 111,478. Status: Ongoing.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: HEALON EndoCoat PRO
Company / brand: Johnson & Johnson Surgical Vision
Lot / serial / date codes: REF/UDI-DI/Lot: 10300012/5050474755093/UA32232, UA32250, UA32268, UA32290, UA32292, UA32303, UA32371, UP31203, UP31205; 10300016/5050474755116/UA32447, UA32448, UA32449, UB33008, UB33026, UB33082, UB33083, UB33175; 10301012/5050474755109/UB33014, UB33041, UB33057, UB33060, UB33100, UB33190; 10301016/5050474755123/UB33084, UB33194
Distribution: Worldwide - US Nationwide distribution including in the states of PA, AL, AZ, AR, CA, FL, IL, IN, IA, KY, LA, ME, MI, MN, MS, NJ, NY, NC, OH, OR, TN, TX, WA, WV, HI, CO, MD, VA, WI, ID, NH, SD, OK, MA, NM, DE, GA, SC, CT, NV, MO, RI, KS, ND and the countries of CA, BE, CH, DE, DK, ES, FR GB, HU, IS, IT, NL, NO, PT, SE.

Agency product description and boundaries

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)

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

Brand: Johnson & Johnson Surgical Vision

Recalls naming this model

FDA Class II · Medical device · September 9, 2026

HEALON EndoCoat PRO recall — Johnson & Johnson Surgical Vision, Inc.

Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, with…

Company / brand: Johnson & Johnson Surgical Vision recalls

Affected product: HEALON EndoCoat PRO recall status

Official ID Z-3064-2026 · Official record ↗

See all Johnson & Johnson Surgical Vision recalls →

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

Found something wrong or missing? Report a data error.

Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.