- Recalling firm
- Katalyst Surgical, LLC
- Reason for recall
- 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.
- Affected products (lot / model / serial)
- 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
- Units affected
- 1330 units
- Distribution pattern
- Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.
- Firm location
- Chesterfield, MO, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2080-2026
- Recall initiated
- March 25, 2026
- FDA classification date
- May 6, 2026
- FDA report date
- May 13, 2026
- FDA event ID
- 98660
- Last updated on HTM Vibe
- July 24, 2026