FDA Medical Device Recalls (openFDA)
Katalyst Surgical, LLC: DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27
- Recall number
- Z-2080-2026
- Recalling firm
- Katalyst Surgical, LLC
- Product
- DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27
- Status
- Open, Classified
- Initiated
- 2026-03-25
- Posted
- 2026-05-06
- Terminated
- not on file
- Reason
- Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding tissues during surgical procedures. These devices fall under the GMDN code 62478 entitled Ophthalmic soft-tissue surgical forceps, probe-like, single use . Double pouched in tyvek pouches, sold in boxes of 5 with an inner and outer box.
- Root 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
- 1330 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.
- Lot, serial or model codes
- Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250429(17)280429(10)M47331 Lot Number: M47331 Expiration Date: 04/29/2028 Model No: DVF4034-27 UDI-DI: (01)1081748902557(11)250527(17)280527(10)M48044 Lot Number: M48044 Expiration Date: 05/27/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250610(17)280610(10)M48163 Lot Number: M48163 Expiration Date: 06/10/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250527(17)280527(10)M47612 Lot Number: M47612 Expiration Date: 05/27/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250617(17)280617(10)M48071 Lot Number: M48071 Expiration Date: 06/17/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250610(17)280610(10)M48164 Lot Number: M48164 Expiration Date: 06/10/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250626(17)280626(10)M48470 Lot Number: M48470 Expiration Date: 06/26/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250626(17)280626(10)M48471 Lot Number: M48471 Expiration Date: 06/26/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250527(17)280527(10)M48043 Lot Number: M48043 Expiration Date: 05/27/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250527(17)280527(10)M47611 Lot Number: M47611 Expiration Date: 05/27/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250626(17)280626(10)M48472 Lot Number: M48472 Expiration Date: 06/26/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250709(17)280709(10)M48658 Lot Number: M48658 Expiration Date: 07/09/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250709(17)280709(10)M48657 Lot Number: M48657 Expiration Date: 07/09/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250807(17)280807(10)M49169 Lot Number: M49169 Expiration Date: 08/07/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250806(17)280806(10)M49170 Lot Number: M49170 Expiration Date: 08/06/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250819(17)280819(10)M49287 Lot Number: M49287 Expiration Date: 08/19/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250825(17)280825(10)M49777 Lot Number: M49777 Expiration Date: 08/25/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250825(17)280825(10)M49776 Lot Number: M49776 Expiration Date: 08/25/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250826(17)280826(10)M49830 Lot Number: M49830 Expiration Date: 08/26/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250826(17)280826(10)M49831 Lot Number: M49831 Expiration Date: 08/26/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250826(17)280826(10)M49907 Lot Number: M49907 Expiration Date: 08/26/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250904(17)280904(10)M49906 Lot Number: M49906 Expiration Date: 09/04/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250909(17)280909(10)M49925 Lot Number: M49925 Expiration Date: 09/09/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250909(17)280909(10)M49926 Lot Number: M49926 Expiration Date: 09/09/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251003(17)281003(10)M50538 Lot Number: M50538 Expiration Date: 10/03/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251003(17)281003(10)M50628 Lot Number: M50628 Expiration Date: 10/03/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251003(17)281003(10)M50629 Lot Number: M50629 Expiration Date: 10/03/2028 Model No:DVF4034-27 UDI-DI: (01)10817489025557(11)251008(17)281008(10)M50897 Lot Number: M50897 Expiration Date: 10/08/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251008(17)281008(10)M50898 Lot Number: M50898 Expiration Date: 10/08/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251007(17)281007(10)M50678 Lot Number: M50678 Expiration Date: 10/07/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251015(17)281015(10)M50917 Lot Number: M50917 Expiration Date: 10/15/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251017(17)281017(10)M50932 Lot Number: M50932 Expiration Date: 10/17/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251107(17)281107(10)M50993 Lot Number: M50993 Expiration Date: 11/07/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251113(17)281113(10)M51034 Lot Number: M51034 Expiration Date: 11/13/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251209(17)281209(10)M51076 Lot Number: M51076 Expiration Date: 12/09/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251209(17)281209(10)M51077 Lot Number: M51077 Expiration Date: 12/09/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251209(17)281209(10)M51131 Lot Number: M51131 Expiration Date: 12/09/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251212(17)281212(10)M51235 Lot Number: M51235 Expiration Date: 12/12/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251212(17)281212(10)M51236 Lot Number: M51236 Expiration Date: 12/12/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251218(17)281218(10)M51292 Lot Number: M51292 Expiration Date: 12/18/2028 Model No: DVF4034-27 UDI-DI: (01)1081748902557(11)251218(17)281218(10)M51293 Lot Number: M51293 Expiration Date: 12/18/2028 Model No: DVF4034-27 UDI-DI: (01)10718489025557(11)260107(17)290107(10)M51329 Lot Number: 51329 Expiration Date: 01/07/2029 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)260115(17)290115(10)M51630 Lot Number: M51630 Expiration Date: 01/15/2029 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)260115(17)290115(10)M51629 Lot Number: M51629 Expiration Date: 01/15/2029 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)260120(17)290120(10)M51699 Lot Number: M51699 Expiration Date: 01/20/2029 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)260120(17)290120(10)M51700 Lot Number: M51700 Expiration Date: 01/20/2029
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HNR
- Firm FEI
- 3007589150
- Firm city
- Chesterfield
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28