DEX Ophthalmic Tissue Forceps 23ga Maculorhexis Forceps Recalled
Katalyst Surgical, LLC is recalling DEX Ophthalmic Tissue Forceps, Model DVF4019-23, due to a field safety corrective action for instructions for use in DEX Forceps and Scissors. The device is distributed worldwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a FDA Class II recall involving a corrective action for instructions for use. The source text does not report any illnesses, injuries, or deaths, and the hazard is related to documentation/labeling rather than a physical device defect or contamination, qualifying it as a moderate-severity recall per the rubric.
Plain-English summary
Katalyst Surgical, LLC is issuing a Field Safety Corrective Action for the DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number DVF4019-23. The recall is related to instructions for use (IFU) in DEX Forceps and Scissors.
The affected device has been distributed worldwide, including to the United States and internationally to Peru, Argentina, South Korea, Japan, and France. A total of 50 units are involved in this recall.
Affected lots include: Lot M49267 (expiration 08/07/2028), Lot M50930 (expiration 10/17/2028), Lot M51230 (expiration 11/13/2028), Lot M51587 (expiration 12/12/2028), Lot M51696 (expiration 01/15/2029), Lot M49921 (expiration 09/04/2028), and Lot M51128 (expiration 11/07/2028).
Healthcare providers and users who have received this device should contact Katalyst Surgical, LLC for further instructions regarding the corrective action for the instructions for use.
The recalled product
- Product
- DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23
- Manufacturer
- Katalyst Surgical, LLC
- Hazard
- instruction-labeling
Distribution
Distributed nationwide across the United States.
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