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 April 6, 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 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, MedicalDevices.
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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