FDA Device recall Z-2080-2026
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27
- FDA Device
- Class II
- ongoing
- Published 2026-05-13
On 2026-05-13 the FDA classified a Class II recall of DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27 by Katalyst Surgical, citing ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surroundin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2080-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-25 |
| Published | 2026-05-13 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Katalyst Surgical |
| Distribution | US |
Product
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27
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.
Identifiers
| code_info | Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250429(17)280429(10)M47331 Lot Number: M47331 Expiration Date: 04/29…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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2080-2026%22
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