CLASS II ONGOING Device recall · Reported 13 May 2026 · FDA Enforcement Report
DEX Ophthalmic Tissue Forceps DEX Stiff End Grasping Forceps recalled
Katalyst Surgical is recalling DEX Ophthalmic Tissue Forceps DEX Stiff End Grasping Forceps, distributed nationwide in the US. The recall was initiated on 25 Mar 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2077-2026
- FDA event ID
- 98660
- Recalling firm
- Katalyst Surgical, Chesterfield, MO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Mar 2026
- FDA classified
- 6 May 2026
- Reported
- 13 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 25 Mar 2026 | Recall initiated by company | |
| 6 May 2026 | Classified by FDA | +42 days |
| 13 May 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Product as listed by the FDA
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.
Questions about this recall
Why was it recalled?
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Which lots are affected?
Lot Code: Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)251125(17)281125(10)M51041 Lot Number: M51041 Expiration Date: 11/25/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)250819(17)280819(10)M50093 Lot Number: M50093 Expiration Date: 08/19/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)250924(17)280924(10)M50293 Lot Number: M50293 Expiration Date: 09/24/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)250924(17)280924(10)M50216 Lot Number: M50216 Expiration Date: 09/24/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)251021(17)281021(10)M50431 Lot Number: M50431 Expiration Date: 10/21/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)251017(17)281017(10)M50543 Lot Number: M50543 Expiration Date: 10/17/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)251023(17)281023(10)M50634 Lot Number: M50634 Expiration Date: 10/23/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)251103(17)281103(10)M50903 Lot Number: M50903 Expiration Date: 11/03/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)251113(17)281113(10)M50937 Lot Number: M50937 Expiration Date: 11/13/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)251125(17)281125(10)M50997 Lot Number: M50997 Expiration Date: 11/25/2028
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
11 other products · FDA event 98660This product is part of a recall event; the main page for the event is DEX Ophthalmic Tissue Forceps DEX Nano Tapered AWH Forceps recalled.
More recalls from Katalyst Surgical
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DEX Ophthalmic Tissue Forceps DEX Stiff Maculorhexis Forceps recalled | Katalyst Surgical | Other | Nationwide |
| Device | CLASS II | DEX Ophthalmic Tissue Forceps DEX Stiff Serrated Forceps recalled | Katalyst Surgical | Other | Nationwide |
| Device | CLASS II | DEX Ophthalmic Tissue Forceps DEX Stiff Maculorhexis Forceps recalled | Katalyst Surgical | Other | Nationwide |
| Device | CLASS II | DEX Ophthalmic Tissue Forceps DEX Super Grip Forceps recalled | Katalyst Surgical | Other | Nationwide |
| Device | CLASS II | DEX Ophthalmic Tissue Forceps DEX Stiff Super Grip Forceps recalled | Katalyst Surgical | Other | Nationwide |
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