RecallReported September 9, 2026
Class II recall by Johnson & Johnson Surgical Vision, Inc.
HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON EndoCoat PRO, REF: 10301012 (EU); HEALON DUET …
FDA's enforcement report of September 9, 2026 lists a Class II recall by Johnson & Johnson Surgical Vision, Inc. of Irvine, CA. Product: HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON EndoCoat PRO, REF: 10301012 (EU); HEALON DUET …. Status: Ongoing.
On the record
- Recalling firm
- Johnson & Johnson Surgical Vision, Inc.
- Location
- Irvine, CA
- Classification
- Class II
- Status
- Ongoing
- Recall number
- Z-3064-2026
- Product type
- Devices
- Recall initiated
- 2026-07-31
- Reported by FDA
- 2026-09-09
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
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From FDA enforcement reports. The record may have changed since it was read.
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