CLASS II ONGOING Device recall · Reported 13 May 2026 · FDA Enforcement Report

DEX Ophthalmic Tissue Forceps DEX NanoTapered AWH Forceps recalled

Katalyst Surgical is recalling DEX Ophthalmic Tissue Forceps DEX NanoTapered AWH 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

Lot, batch or date codesLot Code: Model No: DVF4005-23 UDI-DI: (01)10817489021658(11)250924(17)280924(10)M50529 Lot Number: M50529 Expiration Date: 09/04/2028

Quantity recalled5 units

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-2069-2026
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, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.

Nationwide

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: DVF4005-23 UDI-DI: (01)10817489021658(11)250924(17)280924(10)M50529 Lot Number: M50529 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 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 98660

This product is part of a recall event; the main page for the event is DEX Ophthalmic Tissue Forceps DEX Nano Tapered AWH Forceps recalled.

Reported	Class	Recall	Company	Reason	Where
13 May 2026	CLASS II	DEX Ophthalmic Tissue Forceps DEX Nano Tapered AWH Forceps recalled	Katalyst Surgical	Other	Nationwide
13 May 2026	CLASS II	DEX Ophthalmic Tissue Forceps DEX Maculorhexis Forceps recalled	Katalyst Surgical	Other	Nationwide
13 May 2026	CLASS II	DEX Ophthalmic Tissue Forceps DEX Stiff Asymmetrical Tano Forceps recalled	Katalyst Surgical	Other	Nationwide
13 May 2026	CLASS II	DEX Ophthalmic Tissue Forceps DEX Maculorhexis Forceps recalled	Katalyst Surgical	Other	Nationwide
13 May 2026	CLASS II	DEX Ophthalmic Tissue Forceps DEX Stiff Super Grip Forceps recalled	Katalyst Surgical	Sterility	Nationwide
13 May 2026	CLASS II	DEX Ophthalmic Tissue Forceps DEX Stiff Super Grip Forceps recalled	Katalyst Surgical	Other	Nationwide
13 May 2026	CLASS II	DEX Ophthalmic Tissue Forceps DEX Super Grip Forceps recalled	Katalyst Surgical	Other	Nationwide
13 May 2026	CLASS II	DEX Ophthalmic Tissue Forceps DEX Stiff End Grasping Forceps recalled	Katalyst Surgical	Other	Nationwide
13 May 2026	CLASS II	DEX Ophthalmic Tissue Forceps DEX Stiff Maculorhexis Forceps recalled	Katalyst Surgical	Other	Nationwide
13 May 2026	CLASS II	DEX Ophthalmic Tissue Forceps DEX Stiff Serrated Forceps recalled	Katalyst Surgical	Other	Nationwide
13 May 2026	CLASS II	DEX Ophthalmic Tissue Forceps DEX Stiff Maculorhexis Forceps recalled	Katalyst Surgical	Other	Nationwide

More recalls from Katalyst Surgical

All 12

Reported	Class	Recall	Company	Reason	Where
13 May 2026Device	CLASS II	DEX Ophthalmic Tissue Forceps DEX Stiff Maculorhexis Forceps recalled	Katalyst Surgical	Other	Nationwide
13 May 2026Device	CLASS II	DEX Ophthalmic Tissue Forceps DEX Stiff Serrated Forceps recalled	Katalyst Surgical	Other	Nationwide
13 May 2026Device	CLASS II	DEX Ophthalmic Tissue Forceps DEX Stiff Maculorhexis Forceps recalled	Katalyst Surgical	Other	Nationwide
13 May 2026Device	CLASS II	DEX Ophthalmic Tissue Forceps DEX Stiff End Grasping Forceps recalled	Katalyst Surgical	Other	Nationwide
13 May 2026Device	CLASS II	DEX Ophthalmic Tissue Forceps DEX Super Grip Forceps recalled	Katalyst Surgical	Other	Nationwide

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All 3,809

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2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Other	Nationwide