Vortex Surgical Recalls TID Pharos Illuminated Depressor Over Potential Safety Issues
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Vortex Surgical Inc. is recalling 14,789 units of the TID Pharos Illuminated Depressor distributed worldwide due to concerns classified as Class II by the FDA.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on February 18, 2026 and geographically references Worldwide. 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, MedicalDevices) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.
What Happened
Vortex Surgical Inc., based in Saint Charles, Missouri, has initiated a voluntary recall of the TID Pharos Illuminated Depressor. The FDA has designated this as a Class II recall. While the specific reason for the recall was not detailed in the initial report (listed as "XXX"), a Class II classification indicates that the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote.
Which Products Are Affected
The recall involves the following medical device:
- Product Name: Vortex Surgical TID Pharos Illuminated Depressor
- Model Number: VS0801B
- Lot Number: 2403027R
- UDI Numbers: Pouch UDI 810123481309; Box UDI 810123481712
- Quantity: 14,789 units total (8,651 in the U.S.; 6,138 internationally)
In the United States, the product was distributed to AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, and VA. International distribution includes Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, and Vietnam.
What You Should Do
Healthcare facilities and distributors should immediately check their inventory for Lot 2403027R. Vortex Surgical Inc. notified affected customers via letter starting December 16, 2025. If you have the affected product, follow the instructions provided in the firm's notification letter regarding the return or disposition of the devices.
Why This Matters
Class II recalls are significant as they address products that could potentially cause temporary health issues. Removing these specific lots from the supply chain is a precautionary measure to ensure patient safety during surgical procedures.
Source
Data provided by the FDA under Recall Number Z-1254-2026.
Original source: FDA Official Notice ↗
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