Katalyst Surgical DEX Ophthalmic Tissue Forceps Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Katalyst Surgical, LLC has initiated a Class II recall of DEX Ophthalmic Tissue Forceps due to a Field Safety Corrective Action for the Instructions for Use (IFU).
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 26, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.
What Happened
Katalyst Surgical, LLC initiated a voluntary Field Safety Corrective Action for the IFU in DEX Forceps and Scissors. The recall is classified as Class II by the FDA.
Which Products Are Affected
The affected product is DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25 (also referenced as DVF4034-35 in some lots). A total of 750 units are affected. The recall covers multiple lots with specific UDI-DI, lot numbers, and expiration dates ranging from 04/22/2028 to 02/03/2029. Distribution is worldwide, including US Nationwide and the countries of Peru, Argentina, South Korea, Japan, and France. Recall number: Z-2078-2026.
What You Should Do
Consumers should follow the Field Safety Corrective Action instructions provided by the firm regarding the IFU.
Why This Matters
This Class II recall addresses potential issues with product instructions for a medical device distributed internationally.
Source
FDA recall Z-2078-2026. https://www.fda.gov
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,023 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 26, 2026.
Frequently Asked Questions
Common questions about this FDA recall.