TDC VELOCE 27G Cutter Recall Issued

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

D.O.R.C. Dutch Opthalmic Research Center is recalling TDC VELOCE 27G Two Dimensional Cutters due to loose outer knife complaints.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on July 28, 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, Devices.

What Happened

D.O.R.C. Dutch Opthalmic Research Center Intl B.V. initiated a voluntary recall of certain TDC VELOCE 27G Two Dimensional Cutters after an increase in complaints of a loose outer knife and reports of the outer knife becoming loose during use.

Which Products Are Affected

The recall covers the TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM with the following article numbers: 9268.VIT27, 9311.27G01, 9311.27G02, 9311.27K01, 9311.27K02, 9311.27K03, 9627.G0101, 9627.G0201, 9311.27G01-00. Affected lot numbers include 202511001, 202601070, 51682---1, 51683---1, 54025---1, 54995---1, 56258---1, 56259---1, 64307---1, 64310---1, 69018---1, 75718---1, 76781---1, 76810---1, 77842---1, 79461---1, 80339---1, 80964---1, 81336---1, 82214---1, 82743---1, 83585---1, 84581---1, 85452001, 86070001, 87206001, 90383001, 97231001. A total of 261 boxes (1566 units) are affected. Distribution includes US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Czechia, Finland, France, Germany, Great Britain, Hong Kong, Ireland, Italy, Japan, Netherlands, New Zealand, Poland, Slovenia, South Africa, Spain, Sweden, Taiwan, and Turkey. Recall number Z-2324-2026. Classification: Class II.

What You Should Do

Consumers should contact the recalling firm for further information regarding the recalled devices.

Why This Matters

The recall addresses reports of the outer knife becoming loose during use of these ophthalmic surgical devices distributed worldwide.

Source

FDA recall number Z-2324-2026; FDA enforcement report dated 20260617.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
D.O.R.C. Dutch Opthalmic Research Center is recalling TDC VELOCE 27G Two Dimensional Cutters due to loose outer knife complaints.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.