CLASS II ONGOING Device recall · Reported 13 May 2026 · FDA Enforcement Report
DEX Ophthalmic Tissue Forceps DEX Stiff Serrated Forceps recalled
Katalyst Surgical is recalling DEX Ophthalmic Tissue Forceps DEX Stiff Serrated 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-2072-2026
- 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 Serrated Forceps, Model/Catalog Number: DVF4016-25-S
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.
Questions about this recall
Is DEX Ophthalmic Tissue Forceps DEX Stiff Serrated Forceps recalled?
Yes. Katalyst Surgical recalled DEX Ophthalmic Tissue Forceps DEX Stiff Serrated Forceps on 25 Mar 2026. The recall is Class II and its status is Ongoing. Recall number Z-2072-2026.
Why was it recalled?
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Which lots are affected?
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
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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 Maculorhexis Forceps recalled | Katalyst Surgical | Other | Nationwide |
| Device | CLASS II | DEX Ophthalmic Tissue Forceps DEX Stiff End Grasping 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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