FDA Medical devices recall ·
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model recall
- Recall number
- Z-2077-2026
- Date
- (initiated March 25, 2026)
- Company / brand
- Katalyst Surgical, LLC
722 Goddard Ave, Chesterfield, MO, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 235 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S
Why was it recalled?
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2077-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.