FDA · Class II · September 9, 2026

Johnson & Johnson Surgical Vision recall: HEALON EndoCoat PRO

Johnson & Johnson Surgical Vision, Inc. is recalling HEALON EndoCoat PRO – 111,478. The U.S. Food and Drug Administration published the recall on September 9, 2026; it began on July 31, 2026. Distributed nationwide.

Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Illustration: An FDA laboratory that tests medical devices – not the recalled product. Photo: U.S. Food and Drug Administration, public domain.

Product	HEALON EndoCoat PRO
Brand	Johnson & Johnson Surgical Vision
Company	Johnson & Johnson Surgical Vision, Inc.
Type	Medical devices
Classification	Class II
Recall date	July 31, 2026
Published by FDA	September 9, 2026
Quantity	111,478
Recall ID	99496

As listed by FDA

Recalled products

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)
FDA recall number
Z-3064-2026
Codes, lots and dates
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
Quantity
111,478
Classification
Class II

Exactly as the agency lists them

Identifiers and details

FDA event ID: 99496
Initiated: Voluntary: Firm initiated
Status: Ongoing
Firm location: Irvine, CA, United States

Why it was recalled

The reason the FDA lists: “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.”

Where it was sold

Nationwide. Distribution as the FDA records it: “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.”

What to do

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Official notice: FDA Enforcement Report record (event 99496, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.

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FAQ

About this recall

Is Johnson & Johnson Surgical Vision HEALON EndoCoat PRO recalled?

Yes. Johnson & Johnson Surgical Vision, Inc. recalled it on July 31, 2026; FDA published it September 9, 2026 (Class II). Only the lots, dates or models listed on this page are included.

Why was it recalled?

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.

What should I do if I have it?

Where was it sold?

Nationwide.

Recalls

More recalls

Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.