FDA Medical devices recall ·
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model recall
- Recall number
- Z-2075-2026
- 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
- 645 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-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: DVF4019-25-S UDI-DI: (01)10840096205135(11)251017(17)281017(10)M50541 Lot Number: M50541 Expiration Date: 10/17/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251017(17)281017(10)M50542 Lot Number: M50542 Expiration Date: 10/17/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251023(17)281023(10)M50632 Lot Number: M50632 Expiration Date: 10/23/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251023(17)281023(10)M50633 Lot Number: M50633 Expiration Date: 10/23/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251113(17)281113(10)M50936 Lot Number: M50936 Expiration Date: 11/13/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251113(17)281113(10)M50996 Lot Number: M50996 Expiration Date: 11/13/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251125(17)281125(10)M51039 Lot Number: M51039 Expiration Date: 11/25/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251125(17)281125(10)M51040 Lot Number: M51040 Expiration Date: 11/25/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251125(17)281125(10)M51081 Lot Number: M51081 Expiration Date: 11/25/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251126(17)281126(10)M51138 Lot Number: M51138 Expiration Date: 11/26/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250422(17)280422(10)M47122 Lot Number: M47122 Expiration Date: 04/22/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250422(17)280422(10)M47123 Lot Number: M
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-2075-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.