CLASS II ONGOING Device recall · Reported 13 May 2026 · FDA Enforcement Report
DEX Ophthalmic Tissue Forceps DEX Maculorhexis Forceps recalled
Katalyst Surgical is recalling DEX Ophthalmic Tissue Forceps DEX Maculorhexis 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-2074-2026
- 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 Maculorhexis Forceps, Model/Catalog Number: DVF4019-25
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 Maculorhexis Forceps recalled?
Yes. Katalyst Surgical recalled DEX Ophthalmic Tissue Forceps DEX Maculorhexis Forceps on 25 Mar 2026. The recall is Class II and its status is Ongoing. Recall number Z-2074-2026.
Why was it recalled?
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Which lots are affected?
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 Date: 10/03/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251003(17)281003(10)M50536 Lot Number: M50536 Expiration Date: 10/03/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251003(17)281003(10)M50626 Lot Number: M50626 Expiration Date: 10/03/2028 Model No: DVF4019-25 UDI-DI: (01)10840096205135(11)251007(17)281007(10)M50625 Lot Number: M50625 Expiration Date: 10/07/2028 Model No: DVF4019-25 UDI-DI: (01)10840096205135(11)251008(17)281008(10)M50676 Lot Number: M50676 Expiration Date: 10/08/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251008(17)281008(10)M50895 Lot Number: M50895 Expiration Date: 10/08/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251008(17)281008(10)M50896 Lot Number: M50896 Expiration Date: 10/08/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251008(17)281008(10)M50675 Lot Number: M50675 Expiration Date: 10/08/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251015(17)281015(10)M50914 Lot Number: M50914 Expiration Date: 10/15/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251021(17)281021(10)M51032 Lot Number: M51032 Expiration Date: 10/21/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251029(17)281029(10)M51070 Lot Number: M51070 Expiration Date: 10/29/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251107(17)281107(10)M51129 Lot Number: M51129 Expiration Date: 11/07/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251113(17)281113(10)M51231 Lot Number: M51231 Expiration Date: 11/13/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251209(17)281209(10)M51326 Lot Number: M51326 Expiration Date: 12/09/2028 Model No: DVF4019-25 UDI-DI: (01)10817489022143(11)251212(17)281212(10)M51588 Lot Number: M51588 Expiration Date: 12/12/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250806(17)280806(10)M49164 Lot Number: M49164 Expiration Date: 08/06/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250806(17)280806(10)M49268 Lot Number: M49268 Expiration Date: 08/06/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250806(17)280806(10)M49269 Lot Number: M49269 Expiration Date: 08/06/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250819(17)280819(10)M49773 Lot Number: M49773 Expiration Date: 08/19/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250819(17)280819(10)M49772 Lot Number: M49772 Expiration Date: 08/19/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250826(17)280826(10)M49922 Lot Number: M49922 Expiration Date: 08/26/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250904(17)280904(10)M50067 Lot Number: M50067 Expiration Date: 09/04/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250904(17)280904(10)M50066 Lot Number: M50066 Expiration Date: 09/04/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250917(17)280917(10)M50072 Lot Number: M50072 Expiration Date: 09/17/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250924(17)280924(10)M50421 Lot Number: M50421 Expiration Date: 09/24/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250924(17)280924(10)M50420 Lot Number: M50420 Expiration Date: 09/24/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)251003(17)281003(10)M50533 Lot Number: M50533 Expiration Date: 10/03/2028 Model No; DVF4019-25 UDI-DI: (01)10840096202608(11)251007(17)281007(10)M50535 Lot Number: M50631 Expiration Date: 10/07/2028 Model No; DVF4019-25 UDI-DI: (01)10817489022143(11)250904(17)28094(10)M49923 Lot Number: M49923 Expiration Date: 09/04/2028
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.
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