Class 2 Device Recall DEX Ophthalmic Tissue Forceps

• Date Initiated by Firm: March 25, 2026
• Date Posted: May 06, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2078-2026
• Recall Event ID: 98660
• Product Classification: Forceps, ophthalmic - Product Code HNR
• Product: DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25
• Code Information: Lot Code: Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250422(17)280422(10)M47116 Lot Number: M47116 Expiration Date: 04/22/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250610(17)280610(10)M48162 Lot Number: M48162 Expiration Date: 06/10/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250618(17)280618(10)M48276 Lot Number: M48276 Expiration Date: 06/18/2028 Model No: DVF4034-35 UDI-DI: (01)10817489025540(11)250626(17)280626(10)M48303 Lot Number: M48303 Expiration Date: 06/26/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250730(17)280730(10)M49168 Lot Number: M49168 Expiration Date: 07/30/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250807(17)280807(10)M49270 Lot Number: M49270 Expiration Date: 08/07/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250819(17)280819(10)M49285 Lot Number: M49285 Expiration Date: 08/19/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250819(17)280819(10)M49286 Lot Number: M49286 Expiration Date: 08/19/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250825(17)280825(10)M49775 Lot Number: M49775 Expiration Date: 08/25/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250825(17)280825(10)M49829 Lot Number: M49829 Expiration Date: 08/25/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250826(17)280826(10)M49905 Lot Number: M49905 Expiration Date: 08/26/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250917(17)280917(10)M50289 Lot Number: M50289 Expiration Date: 09/17/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250917(17)280917(10)M50208 Lot Number: M50208 Expiration Date: 09/17/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250924(17)280924(10)M50290 Lot Number: M50290 Expiration Date: 09/24/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)251015(17)281015(10)M50916 Lot Number: M50916 Expiration Date: 10/15/2028 Model No:DVF4034-25 UDI-DI: (01)10817489025540(11)251020(17)281020(10)M50992 Lot Number: M50992 Expiration Date: 10/20/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)251023(17)281023(10)M51033 Lot Number: M51033 Expiration Date: 10/23/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)251029(17)281029(10)M51074 Lot Number: M51074 Expiration Date: 10/29/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)251029(17)281029(10)M51075 Lot Number: M51075 Expiration Date: 10/29/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)251113(17)281113(10)M51234 Lot Number: M51234 Expiration Date: 11/13/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)251125(17)281125(10)M51290 Lot Number: M51290 Expiration Date: 11/25/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)251126(17)281126(10)M51291 Lot Number: M51291 Expiration Date: 11/26/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)251209(17)281209(10)M51521 Lot Number: M51521 Expiration Date: 12/09/2028 Model No:DVF4034-25 UDI-DI: (01)10817489025540(11)251218(17)281218(10)M51628 Lot Number: M51628 Expiration Date: 12/18/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)260120(17)290120(1)M51698 Lot Number: M51698 Expiration Date: 01/20/2029 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)260203(17)290203(10)M51893 Lot Number: M51893 Expiration Date: 02/03/2029 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)260203(17)290203(10)M52019 Lot Number: M52019 Expiration Date: 02/03/2029
• FEI Number: 3007589150
• Recalling Firm/ Manufacturer: Katalyst Surgical, LLC; 722 Goddard Ave; Chesterfield MO 63005-1100
• For Additional Information Contact: Alex Bergoudian; +1-636-5365950
• Manufacturer Reason for Recall: Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
• FDA Determined Cause: Under Investigation by firm
• Action: 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.
• Quantity in Commerce: 750 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.