Illuminated depressors recalled with no reason given in the record
Vortex Surgical is recalling the TID Pharos Illuminated Depressor, VS0801B. The reason field in the enforcement record reads only "XXX", so no hazard is stated.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: Scored 2 as a voluntary precautionary action: the record's reason field reads "XXX" and names no hazard, defect or consequence to assess against the rubric.
Plain-English summary
The Vortex Surgical TID Pharos Illuminated Depressor, VS0801B, is being recalled by Vortex Surgical Inc.
The reason for recall field in the enforcement record reads "XXX". No hazard, defect or consequence is stated in the record, so none is given here.
The record lists 14,789 units, of which 8,651 are in the US and 6,138 outside it, under pouch UDI 810123481309 and box UDI 810123481712, lot 2403027R. Distribution was worldwide, including nationwide in the United States across the states listed in the record and to the countries listed. The record states the action was voluntary and firm initiated, and the FDA has classified it as Class II.
Facilities should quarantine the affected lot and contact Vortex Surgical for the recall instructions, which are not set out in this record.
The recalled product
- Product
- Vortex Surgical TID Pharos Illuminated Depressor, VS0801B
- Manufacturer
- Vortex Surgical Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Pouch UDI 810123481309 Box UDI 810123481712 Lot 2403027R
Distribution
Part of a larger recall action
This product is one of 13 recalled by Vortex Surgical Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 13 products in this recall →Related recalls
Same manufacturer · Vortex Surgical Inc.
See all →- HighInjection kits recalled over voids in sterile Tyvek pouch seals
FDA (Devices) · 2026-02-11
- HighBackflush instruments recalled over voids in sterile pouch seals
FDA (Devices) · 2026-02-11
- HighOertli laser probes recalled over voids in sterile pouch seals
FDA (Devices) · 2026-02-11
- HighScleral IOL markers recalled over voids in sterile pouch seals
FDA (Devices) · 2026-02-11
- HighSubretinal injection cannulas recalled over voids in pouch seals
FDA (Devices) · 2026-02-11
Same hazard · reason not stated
See all →- ModerateVitrectomy probe packs recalled with no reason stated in the record
FDA (Devices) · 2025-12-03
- ModerateSuture retention devices recalled with no reason stated in FDA record
FDA (Devices) · 2025-08-27
Similar recalls
- ModerateLaser probes recalled because they may not pass smoothly through a cannula
FDA (Devices) · 2026-01-07
- ModerateInsight Instruments Recalls MLS Torpedo Mini-Light Ophthalmic Illuminator
FDA (Devices) · 2013-11-13
- ModerateSteris Recalls Harmony vLED Surgical Lighting Systems Due to Inconsistent Illumination
FDA (Devices) · 2015-01-14
- ModerateSuture retention devices recalled with no reason stated in FDA record
FDA (Devices) · 2025-08-27
- ModerateSiemens RAD Fluoro Uro System Recalled for Image Malfunction
FDA (Devices) · 2014-07-02
- ModerateMedical device recall: VS3 Iridium infrared fluorescence microscope
FDA (Devices) · 2022-11-30