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-2074-2026
• Recall Event ID: 98660
• Product Classification: Forceps, ophthalmic - Product Code HNR
• Product: DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25
• Code Information: Lot Code: Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)250904(17)280904(10)M50065 Lot Number: M50065 Expiration Date: 09/04/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)250909(17)280909(10)M50068 Lot Number: M50068 Expiration Date: 09/09/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)250909(17)280909(10)M50069 Lot Number: M50069 Expiration Date: 09/09/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)250909(17)280909(10)M50070 Lot Number: M50070 Expiration Date: 09/09/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)250917(17)280917(10)M50071 Lot Number: M50071 Expiration Date: 09/17/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)250924(17)280924(10)M50422 Lot Number: M50422 Expiration Date: 09/24/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)250924(17)280924(10)M50423 Lot Number: M50423 Expiration Date: 09/24/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251003(17)281003(10)M50534 Lot Number: M50534 Expiration Date: 10/03/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251003(17)281003(10)M50536 Lot Number: M50536 Expiration Date: 10/03/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251003(17)281003(10)M50626 Lot Number: M50626 Expiration Date: 10/03/2028 Model No: DVF4019-25 UDI-DI: (01)10840096205135(11)251007(17)281007(10)M50625 Lot Number: M50625 Expiration Date: 10/07/2028 Model No: DVF4019-25 UDI-DI: (01)10840096205135(11)251008(17)281008(10)M50676 Lot Number: M50676 Expiration Date: 10/08/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251008(17)281008(10)M50895 Lot Number: M50895 Expiration Date: 10/08/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251008(17)281008(10)M50896 Lot Number: M50896 Expiration Date: 10/08/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251008(17)281008(10)M50675 Lot Number: M50675 Expiration Date: 10/08/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251015(17)281015(10)M50914 Lot Number: M50914 Expiration Date: 10/15/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251021(17)281021(10)M51032 Lot Number: M51032 Expiration Date: 10/21/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251029(17)281029(10)M51070 Lot Number: M51070 Expiration Date: 10/29/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251107(17)281107(10)M51129 Lot Number: M51129 Expiration Date: 11/07/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251113(17)281113(10)M51231 Lot Number: M51231 Expiration Date: 11/13/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251209(17)281209(10)M51326 Lot Number: M51326 Expiration Date: 12/09/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251212(17)281212(10)M51588 Lot Number: M51588 Expiration Date: 12/12/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250806(17)280806(10)M49164 Lot Number: M49164 Expiration Date: 08/06/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250806(17)280806(10)M49268 Lot Number: M49268 Expiration Date: 08/06/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250806(17)280806(10)M49269 Lot Number: M49269 Expiration Date: 08/06/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250819(17)280819(10)M49773 Lot Number: M49773 Expiration Date: 08/19/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250819(17)280819(10)M49772 Lot Number: M49772 Expiration Date: 08/19/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250826(17)280826(10)M49922 Lot Number: M49922 Expiration Date: 08/26/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250904(17)280904(10)M50067 Lot Number: M50067 Expiration Date: 09/04/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250904(17)280904(10)M50066 Lot Number: M50066 Expiration Date: 09/04/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250917(17)280917(10)M50072 Lot Number: M50072 Expiration Date: 09/17/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250924(17)280924(10)M50421 Lot Number: M50421 Expiration Date: 09/24/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250924(17)280924(10)M50420 Lot Number: M50420 Expiration Date: 09/24/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)251003(17)281003(10)M50533 Lot Number: M50533 Expiration Date: 10/03/2028 Model No; DVF4019-25 UDI-DI: (01)10840096202608(11)251007(17)281007(10)M50535 Lot Number: M50631 Expiration Date: 10/07/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250904(17)28094(10)M49923 Lot Number: M49923 Expiration Date: 09/04/2028
• 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: 670 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.