Katalyst Surgical, LLC recalls DEX Ophthalmic Tissue Forceps
Reason for recall
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25
Lot / code information
- Lot #
- Code:
- Model
- DVF4019-25
- UDI
- (01)10817489022143(11)250904(17)280904(10)M50065
- Lot #
- M50065 Expiration Date: 09/04/2028
- Model
- DVF4019-25
- UDI
- (01)10817489022143(11)250909(17)280909(10)M50068
- Lot #
- M50068 Expiration Date: 09/09/2028
- Model
- DVF4019-25
- UDI
- (01)10817489022143(11)250909(17)280909(10)M50069
- Lot #
- M50069 Expiration Date: 09/09/2028
- Model
- DVF4019-25
- UDI
- (01)10817489022143(11)250909(17)280909(10)M50070
- Lot #
- M50070 Expiration Date: 09/09/2028
- Model
- DVF4019-25
- UDI
- (01)10817489022143(11)250917(17)280917(10)M50071
- Lot #
- M50071 Expiration Date: 09/17/2028
- Model
- DVF4019-25
- UDI
- (01)10817489022143(11)250924(17)280924(10)M50422
- Lot #
- M50422 Expiration Date: 09/24/2028
- Model
- DVF4019-25
- UDI
- (01)10817489022143(11)250924(17)280924(10)M50423
- Lot #
- M50423 Expiration Date: 09/24/2028
- Model
- DVF4019-25
- UDI
- (01)10817489022143(11)251003(17)281003(10)M50534
- Lot #
- M50534 Expiration Date: 10/03/2028
- Model
- DVF4019-25
- UDI
- (01)10817489022143(11)251003(17)281003(10)M50536
- Lot #
- M50536 Expiration Date: 10/03/2028
- Model
- DVF4019-25
- UDI
- (01)10817489022143(11)251003(17)281003(10)M50626
- Lot #
- M50626 Expiration Date: 10/03/2028
- Model
- DVF4019-25
- UDI
- (01)10840096205135(11)251007(17)281007(10)M50625
- Lot #
- M50625 Expiration Date: 10/07/2028
- Model
- DVF4019-25
- UDI
- (01)10840096205135(11)251008(17)281008(10)M50676
- Lot #
- M50676 Expiration Date: 10/08/2028
- Model
- DVF4019-25
- UDI
- (01)10817489022143(11)251008(17)281008(10)M50895
- Lot #
- M50895 Expiration Date: 10/08/2028
- Model
- DVF4019-25
- UDI
- (01)10817489022143(11)251008(17)281008(10)M50896
- Lot #
- M50896 Expiration Date: 10/08/2028
- Model
- DVF4019-25
- UDI
- (01)10817489022143(11)251008(17)281008(10)M50675
- Lot #
- M50675 Expiration Date: 10/08/2028
- Model
- DVF4019-25
- UDI
- (01)10817489022143(11)251015(17)281015(10)M50914
- Lot #
- M50914 Expiration Date: 10/15/2028
- Model
- DVF4019-25
- UDI
- (01)10817489022143(11)251021(17)281021(10)M51032
- Lot #
- M51032 Expiration Date: 10/21/2028
- Model
- DVF4019-25
- UDI
- (01)10817489022143(11)251029(17)281029(10)M51070
- Lot #
- M51070 Expiration Date: 10/29/2028
- Model
- DVF4019-25
- UDI
- (01)10817489022143(11)251107(17)281107(10)M51129
- Lot #
- M51129 Expiration Date: 11/07/2028
- Model
- DVF4019-25
- UDI
- (01)10817489022143(11)251113(17)281113(10)M51231
- Lot #
- M51231 Expiration Date: 11/13/2028
- Model
- DVF4019-25
- UDI
- (01)10817489022143(11)251209(17)281209(10)M51326
- Lot #
- M51326 Expiration Date: 12/09/2028
- Model
- DVF4019-25
- UDI
- (01)10817489022143(11)251212(17)281212(10)M51588
- Lot #
- M51588 Expiration Date: 12/12/2028
- Model
- ; DVF4019-25
- UDI
- (01)10817489022143(11)250806(17)280806(10)M49164
- Lot #
- M49164 Expiration Date: 08/06/2028
- Model
- ; DVF4019-25
- UDI
- (01)10817489022143(11)250806(17)280806(10)M49268
- Lot #
- M49268 Expiration Date: 08/06/2028
- Model
- ; DVF4019-25
- UDI
- (01)10817489022143(11)250806(17)280806(10)M49269
- Lot #
- M49269 Expiration Date: 08/06/2028
- Model
- ; DVF4019-25
- UDI
- (01)10817489022143(11)250819(17)280819(10)M49773
- Lot #
- M49773 Expiration Date: 08/19/2028
- Model
- ; DVF4019-25
- UDI
- (01)10817489022143(11)250819(17)280819(10)M49772
- Lot #
- M49772 Expiration Date: 08/19/2028
- Model
- ; DVF4019-25
- UDI
- (01)10817489022143(11)250826(17)280826(10)M49922
- Lot #
- M49922 Expiration Date: 08/26/2028
- Model
- ; DVF4019-25
- UDI
- (01)10817489022143(11)250904(17)280904(10)M50067
- Lot #
- M50067 Expiration Date: 09/04/2028
- Model
- ; DVF4019-25
- UDI
- (01)10817489022143(11)250904(17)280904(10)M50066
- Lot #
- M50066 Expiration Date: 09/04/2028
- Model
- ; DVF4019-25
- UDI
- (01)10817489022143(11)250917(17)280917(10)M50072
- Lot #
- M50072 Expiration Date: 09/17/2028
- Model
- ; DVF4019-25
- UDI
- (01)10817489022143(11)250924(17)280924(10)M50421
- Lot #
- M50421 Expiration Date: 09/24/2028
- Model
- ; DVF4019-25
- UDI
- (01)10817489022143(11)250924(17)280924(10)M50420
- Lot #
- M50420 Expiration Date: 09/24/2028
- Model
- ; DVF4019-25
- UDI
- (01)10817489022143(11)251003(17)281003(10)M50533
- Lot #
- M50533 Expiration Date: 10/03/2028
- Model
- ; DVF4019-25
- UDI
- (01)10840096202608(11)251007(17)281007(10)M50535
- Lot #
- M50631 Expiration Date: 10/07/2028
- Model
- ; DVF4019-25
- UDI
- (01)10817489022143(11)250904(17)28094(10)M49923
- Lot #
- M49923 Expiration Date: 09/04/2028
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What the firm is doing
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.
DistributionShow detailsHide
Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2074-2026
- FDA device classification · HNROfficial FDA classification for this device type
- CFR regulation · 21 CFR 886.4350The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Katalyst Surgical, LLCSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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