25ga (0.50mm) DEX Tips™ Super Grip Forceps
Catalogue number CVF4034-25, listed by Katalyst Surgical, LLC, United States, under Forceps, Ophthalmic. 12 manufacturers in China are registered for this product code.
12manufacturers in China registered for this device type
1catalogue number
12recalls on this code
Who Else Makes It
Concentrated in Jiangsu (9), Shanghai (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
| Belle Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 20 |
| Sihong Ophsurin Co., Ltd. | Suqian | Jiangsu | Manufacturer | 17 |
| Huaian Frimen Co., Ltd. | Huaian | Jiangsu | Manufacturer | 16 |
| Huaian Wolfram Surgical Instruments | Huaian | Jiangsu | Manufacturer | 14 |
| Visuscience Meditech Co., Ltd. | Wuxi | Jiangsu | Specification developer | 9 |
Record
| Listed by | Katalyst Surgical, LLC, United States |
|---|---|
| FDA product code | HNR |
| Device type | Forceps, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-11-27 |
| Record revised | 2026-07-09 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2025-03-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| CVF4034-25 | 5 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 812 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 542 |
| Walcott Rx Products | Walcott Rx Product Inc | 365 |
| Sklar | Sklar Corporation | 346 |
| Millennium | Avalign Technologies, Inc. | 329 |
| MR Phaco | Crestpoint Management Ltd. | 322 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 313 |
| Epsilon USA | Epsilon EYE Care PVT., Ltd. | 283 |
| Stephens Instruments | Krishna Imports Inc | 275 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 256 |
| Rumex | Rumex International Co. | 248 |
| Assi | Accurate Surgical & Scientific Instruments Corp. | 195 |
Showing 12 of 1,959. All products under Forceps, Ophthalmic
Recalls
12 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-03-25 | Class II | Under Investigation by firm | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | 670 units |
| 2026-03-25 | Class II | Under Investigation by firm | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | 150 units |
| 2026-03-25 | Class II | Under Investigation by firm | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | 80 units |
| 2026-03-25 | Class II | Under Investigation by firm | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | 235 units |
| 2026-03-25 | Class II | Under Investigation by firm | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | 5 units |
| 2026-03-25 | Class II | Under Investigation by firm | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | 750 units |
| 2026-03-25 | Class II | Under Investigation by firm | 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 unde | 1330 units |
| 2026-03-25 | Class II | Under Investigation by firm | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | 50 units |
| 2026-03-25 | Class II | Under Investigation by firm | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | 645 units |
| 2026-03-25 | Class II | Under Investigation by firm | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | 90 units |
| 2026-03-25 | Class II | Under Investigation by firm | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | 10 units |
| 2026-03-25 | Class II | Under Investigation by firm | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | 50 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.