The Recall Desk
ModerateFDA (Devices)·Z-2071-2026·Announced 2026-05-13

DEX Ophthalmic Tissue Forceps instructions for use correction

Katalyst Surgical is issuing a corrective action for instructions in DEX Ophthalmic Tissue Forceps (Model DVF4014-25-S). The recall affects 80 units distributed worldwide including the US and Peru, Argentina, South Korea, Japan, and France.

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 an FDA Class II recall involving a corrective action for instructions for use. The source text does not report any injuries or illnesses, and the hazard is related to instructional documentation rather than a device defect that poses imminent risk of serious harm.

Plain-English summary

Katalyst Surgical, LLC is issuing a field safety corrective action for instructions for use (IFU) in the DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number DVF4014-25-S. This device is used in ophthalmic surgical procedures.

A total of 80 units have been distributed worldwide, including throughout the US and to Peru, Argentina, South Korea, Japan, and France. The affected lot numbers are M49277 (expiration 09/09/2028), M47588 (expiration 05/13/2028), M47364 (expiration 05/06/2028), and M47363 (expiration 05/06/2028).

The FDA has classified this as a Class II recall. Users who have received these devices should contact Katalyst Surgical, LLC regarding the corrective action for the instructions for use.

The recalled product

Product
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S
Manufacturer
Katalyst Surgical, LLC
Category
Medical Device — Surgical Instruments / Ophthalmic
Hazard
  • instruction-error

Distribution

Distributed nationwide across the United States.

Related recalls

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