FDA Medical Device Recalls (openFDA)
Katalyst Surgical, LLC: DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S
- Recall number
- Z-2071-2026
- Recalling firm
- Katalyst Surgical, LLC
- Product
- DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S
- Status
- Open, Classified
- Initiated
- 2026-03-25
- Posted
- 2026-05-06
- Terminated
- not on file
- Reason
- Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
- Root cause
- Under Investigation by firm
- Action
- A Field Safety Notification: Field Safety Corrective Action for IFU in DEX Forceps and Scissors dated 3/19/26 was sent to customers. FIELD SAFETY ACTIONS REQUIRED As a customer identified in the receipt of one or more of the affected lots, you are requested/required to take the following steps: 1. Please confirm receipt of this Field Safety Notification by email, either by replying to the sender or using the email addresses listed in the signature at the bottom of this notice. 2. Review the Individualized List of Affected Lot Numbers by Customer provided in the email for lots that were distributed to your facility. Identify all of these lots that currently remain in your stock and place them on hold. 3. Provide information to Katalyst Surgical team identifying which lots are currently in stock and on hold at your facility. Katalyst Surgical will send a replacement correct IFU for each affected box. 4. Upon receipt of the correct IFU, remove the incorrect IFU, replace the correct IFU in the box, and destroy the incorrect IFU. Approval for Modification including instructions will accompany the replacement IFUs. 5. We recommend you reach out to your customers/users of these DEX products with this information. Katalyst Surgical will gladly provide correct replacement IFU documents to you for further distribution. Katalyst Surgical deeply regrets the inconvenience this causes. We assure you of our continuous support and commitment to safety and quality. Please do not hesitate to contact our team if you have any further questions.
- Quantity
- 80 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.
- Lot, serial or model codes
- Lot Code: Model No: DVF4014-25-S UDI-DI: (01)10840096205111(11)250909(17)280909(10)M49277 Lot Number: M49277 Expiration Date: 09/09/2028 Model No: DVF4014-25-S UDI-DI: (01)10840096205111(11)250513(17)280513(10)M47588, Lot Number: M47588 Expiration Date: 05/13/2028 Model No: DVF4014-25-S UDI-DI: (01)10840096205111(11)250506(17)280506(10)M47364, Lot Number: M47364 Expiration Date: 05/06/2028 Model No: DVF4014-25-S UDI-DI: (01)10840096205111(11)250506(17)280506(10)M47363 Lot Number: M47363 Expiration Date: 05/06/2028
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HNR
- Firm FEI
- 3007589150
- Firm city
- Chesterfield
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28