DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis… recallZ-2075-2026 · Katalyst Surgical, LLC · initiated Mar 25, 2026

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number

Z-2075-2026

Status

Open, Classified

Initiated by the company

Mar 25, 2026

Posted by the FDA

May 6, 2026

Recalling firm

Katalyst Surgical, LLC

Quantity

645 units

Product code

HNR

Distribution

Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.

Product description

DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• 25ga DEX Stiff Maculorhexis Forceps DVF4019-25-S

  Katalyst Surgical LLC · Forceps, Ophthalmic
  2 recalls0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 98660).

• Z-2071-2026 · Open, Classified
  DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S
• Z-2072-2026 · Open, Classified
  DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S
• Z-2074-2026 · Open, Classified
  DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25
• Z-2077-2026 · Open, Classified
  DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S
• Z-2078-2026 · Open, Classified
  DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25
• Z-2079-2026 · Open, Classified
  DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S
• Z-2080-2026 · Open, Classified
  DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27