United StatesDEX Ophthalmic Tissue Forceps sold by Katalyst Surgical (models including DVF4005‑23, DVF4005‑25, DVF4014‑25‑S, DVF4016‑25‑S, DVF4019‑23/25/27, DVF4022‑25‑S, DVF4034‑25/25‑S/27 and similar DEX forceps) are affected; units are sterile, double‑pouched and were distributed worldwide. The recall was initiated as a Field Safety Corrective Action related to the devices’ Instructions for Use (IFU).
What's being recalled
DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23
DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S
DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23
DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S
DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27
Recalling firm: Katalyst Surgical, LLC, Chesterfield, MO, United States.
How to identify it
Lot Code: Model No: DVF4005-23 UDI-DI: (01)10817489021658(11)250924(17)280924(10)M50529 Lot Number: M50529 Expiration Date: 09/04/2028 Lot Code: Model No: DVF4005-25 UDI-DI: (01)10817489021665(11)250924(17)280924(10)M50530 Lot Number: M50530 Expiration Date: 09/24/2028 Lot Code: Model No: DVF4014-25-S UDI-DI: (01)10840096205111(11)250909(17)280909(10)M49277 Lot Number: M49277 Expiration Date: 09/09/2028 Model No: DVF4014-25-S UDI-DI: (01)10840096205111(11)250513(17)280513(10)M47588, Lot Number: M47588 Expiration Date: 05/13/2028 Model No: DVF4014-25-S UDI-DI: (01)10840096205111(11)250506(17)280506(10)M47364, Lot Number: M47364 Expiration Date: 05/06/2028 Model No: DVF4014-25-S UDI-DI: (01)10840096205111(11)250506(17)280506(10)M47363 Lot Number: M47363 Expiration Date: 05/06/2028 Lot Code: Model No:DVF4016-25-S UDI-DI: (01)10840096205128(11)250709(17)280709(10)M48801 Lot Number: M48801 Expiration Date: 07/09/2028 Model No: DVF4016-25-S UDI-DI: (01)10840096205128(11)251010(17)281010(10)M49278 Lot Number: M49278 Expiration Date: 10/10/2028 Model No: DVF4016-25-S UDI-DI: (01)10840096205128(11)250429(17)280429(10)M47582 Lot Number: M47582 Expiration Date: 04/29/2028 Model No: DVF4016-25-S UDI-DI: (01)10840096205128(11)250527(17)280527(10)M48049 Lot Number: M48049 Expiration Date: 05/27/2028 Model No: DVF4016-25-S UDI-DI: (01)10840096205128(11)251125(17)281125(10)M51038 Lot Number: M451038 Expiration Date: 11/25/2028 Lot Code: Model No: DVF4019-23 UDI-DI: (01)10817489022136(11)250807(17)280807(10)M49267 Lot Number: M49267 Expiration Date: 08/07/2028 Model No: DVF4019-23 UDI-DI: (01)10817489022136(11)251017(17)281017(10)M50930 Lot Number: M50930 Expiration Date: 10/17/2028 Model No: DVF4019-23 UDI-DI: (01)10817489022136(11)251113(17)281113(10)M51230 Lot Number: M51230 Expiration Date: 11/13/2028 Model No: DVF4019-23 UDI-DI: (01)10817489022136(11)251212(17)281212(10)M51587 Lot Number: M51587 Expiration Date: 12/12/2028 Model No: DVF4019-23 UDI-DI…
The hazard
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)