FDA DevicesClass II
DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Numb...
Published: May 13, 2026Recall ID: Z-2074-2026Category: devicesCountry: US
Reason for Recall / Hazard
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Product Description & Identification
DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25
Additional Source Details
| Field | Value |
|---|---|
| City | Chesterfield |
| State | MO |
| Event id | 98660 |
| Address 1 | 722 Goddard Ave |
| Code info | 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 ... [TRUNCATED] |
| Postal code | 63005-1100 |
| Report date | 20260513 |
| Product type | Devices |
| Product quantity | 670 units |
| Reason for recall | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260325 |
| Initial firm notification | Letter |
| Center classification date | 20260506 |
Overview
- Recalling FirmKatalyst Surgical, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.