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U.S. Department of Health and Human Services

Class 2 Device Recall DEX Ophthalmic Tissue Forceps

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 Class 2 Device Recall DEX Ophthalmic Tissue Forcepssee related information
Date Initiated by FirmMarch 25, 2026
Date PostedMay 06, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2076-2026
Recall Event ID 98660
Product Classification Forceps, ophthalmic - Product Code HNR
ProductDEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27
Code Information Lot Code: Model No: DVF4019-27 UDI-DI: (01)10817489022150(11)251017(17)281017(10)M50931 Lot Number: M50931 Expiration Date: 10/17/2028 Model No: DVF4019-27 UDI-DI: (01)10817489022150(11)251209(17)281209(10)M51130 Lot Number: M51130 Expiration Date: 12/09/2028 Model No: DVF4019-27 UDI-DI: (01)10817489022150(11)260115(17)290115(10)M51589 Lot Number: M51589 Expiration Date: 01/15/2029 Model No: DVF4019-27 UDI-DI: (01)10817489022150(11)260205(17)290205(10)M52018 Lot Number: M52018 Expiration Date: 02/05/2029 Model No: DVF4019-27 UDI-DI: (01)10817489022150(11)260220(17)290220(10)M52195 Lot Number: M52195 Expiration Date: 2/20/2029 Model No: DVF4019-27 UDI-DI: (01)10817489022150(11)250909(17)280909(10)M50073 Lot Number: M50073 Expiration Date: 09/09/2028 Model No: DVF4019-27 UDI-DI: (01)10817489022150(11)250909(17)280909(10)M50287 Lot Number: M50287 Expiration Date: 09/09/2028 Model No: DVF4019-27 UDI-DI: (01)10817489022150(11)251007(17)281007(10)M50677 Lot Number: M50677 Expiration Date: 10/07/2028 Model No: DVF4019-27 UDI-DI: (01)10817489022150(11)251103(17)281103(0)M50991 Lot Number: M50991 Expiration Date: 11/03/2028 Model No: DVF4019-27 UDI-DI: (01)10817489022150(11)251113(17)281113(10)M51071 Lot Number: M51071 Expiration Date: 11/13/2028
FEI Number 3007589150
Recalling Firm/
Manufacturer		 Katalyst Surgical, LLC
722 Goddard Ave
Chesterfield MO 63005-1100
For Additional Information ContactAlex Bergoudian
+1-636-5365950
Manufacturer Reason
for Recall		Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
FDA Determined
Cause 2		Under Investigation by firm
ActionA 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 in Commerce150 units
DistributionWorldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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