CLASS II ONGOING Device recall · Reported 9 Sep 2026 · FDA Enforcement Report
Healon EndoCoat PRO recalled by Johnson & Johnson Surgical
Johnson & Johnson Surgical Vision is recalling Healon EndoCoat PRO, distributed nationwide in the US. The recall was initiated on 31 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3064-2026
- FDA event ID
- 99496
- Recalling firm
- Johnson & Johnson Surgical Vision, Irvine, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Jul 2026
- FDA classified
- 31 Aug 2026
- Reported
- 9 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 31 Jul 2026 | Recall initiated by company | |
| 31 Aug 2026 | Classified by FDA | +31 days |
| 9 Sep 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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)
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaine
Questions about this recall
Is Healon EndoCoat PRO recalled?
Yes. Johnson & Johnson Surgical Vision recalled Healon EndoCoat PRO on 31 Jul 2026. The recall is Class II and its status is Ongoing. Recall number Z-3064-2026.
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.
Which lots are affected?
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
Where was it sold?
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 should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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