Katalyst Surgical, LLC recalls DEX Ophthalmic Tissue Forceps

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

A Field Safety Notification: Field Safety Corrective Action for IFU in DEX Forceps and Scissors dated 3/19/26 was sent to customers. FIELD SAFETY ACTIONS REQUIRED As a customer identified in the receipt of one or more of the affected lots, you are requested/required to take the following steps: 1. Please confirm receipt of this Field Safety Notification by email, either by replying to the sender or using the email addresses listed in the signature at the bottom of this notice. 2. Review the Individualized List of Affected Lot Numbers by Customer provided in the email for lots that were distributed to your facility. Identify all of these lots that currently remain in your stock and place them on hold. 3. Provide information to Katalyst Surgical team identifying which lots are currently in stock and on hold at your facility. Katalyst Surgical will send a replacement correct IFU for each affected box. 4. Upon receipt of the correct IFU, remove the incorrect IFU, replace the correct IFU in the box, and destroy the incorrect IFU. Approval for Modification including instructions will accompany the replacement IFUs. 5. We recommend you reach out to your customers/users of these DEX products with this information. Katalyst Surgical will gladly provide correct replacement IFU documents to you for further distribution. Katalyst Surgical deeply regrets the inconvenience this causes. We assure you of our continuous support and commitment to safety and quality. Please do not hesitate to contact our team if you have any further questions.

• FDA enforcement recordOfficial FDA database entry for Z-2075-2026
• FDA device classification · HNROfficial FDA classification for this device type
• CFR regulation · 21 CFR 886.4350The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Katalyst Surgical, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.