Johnson & Johnson Surgical Vision, Inc. recalls HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON EndoCoat PRO, REF:…
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…
Read the official notice →- Date
- 2026-09-09
- Country
- United States
- Brand
- Johnson & Johnson Surgical Vision
- Product
- HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON EndoCoat PRO, REF: 10301012 (EU); HEALON…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states of PA, AL, AZ,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Johnson & Johnson Surgical Vision recalls
- 2024-05-08
USJohnson & Johnson Surgical Vision, Inc. recalls Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The…
Due to a manufacturing variation of the irrigation sleeves which could result in a missing port hole, this non-conformity could lead to insufficient flow to cool the ultrasonic phaco tip, potentially leading to an…
FDA · DeviceJohnson & Johnson Surgical Vision, Inc.U.S. Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, LA, MA,…Official notice →- 2024-01-24
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Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks do not meet product specifications for the allowable angle between Low Power Meridian (LPM) and toric cylinder axis marks.
FDA · DeviceJohnson & Johnson Surgical Vision, Inc.International distribution to the country of Japan.Official notice → - 2023-08-09
- US
Johnson & Johnson Surgical Vision, Inc. recalls TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only
Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
FDA · DeviceJohnson & Johnson Surgical Vision, Inc.International distribution to the countries of China, India, Korea.Official notice → - US
Johnson & Johnson Surgical Vision, Inc. recalls VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
Weld protrusion/physical gap between the housing and pack cover, may exceed design specification, due to a manufacturing issue, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the…
FDA · DeviceJohnson & Johnson Surgical Vision, Inc.Worldwide - US Nationwide distribution including in the states of NC, OH, NY,…Official notice → - 2023-02-01
- US
Johnson & Johnson Surgical Vision, Inc. recalls FUSION Dual Pump Packs, REF: OPO73
Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and…
FDA · DeviceJohnson & Johnson Surgical Vision, Inc.US: FL, MS, NY, TN, TX, IL, MN, OH. OUS: Belgium, China, Estonia, France,…Official notice → - 2022-11-09
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Johnson & Johnson Surgical Vision, Inc. recalls THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac…
Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing inspection, 2) Insufficient irrigation…
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Other drugs & medical recalls in the United States
- 2026-09-09
- US
Boston Scientific Corporation recalls LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions…
There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical…
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Medline Industries, LP recalls Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ADULT BLOOD CULTURE KIT DYNDH1444D BLOOD CULTR KT DIVRSN DEVICE…
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A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…Official notice → - US
Medline Industries, LP recalls Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1193; 2) BLOOD CULTURE KIT 2 W/CONNECT, Model Number:…
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the…
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