Vortex Surgical Inc.

Complete recall history across all FDA and CPSC categories — 15 total recalls

Vortex Surgical Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (15)

FDA medical device enforcement actions by Vortex Surgical Inc.

Date Product Reason Class
Dec 16, 2025 Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker There may be voids located in the seal of Tyvek pouches associated with ident... Class II
Dec 16, 2025 Rumex Disposable Diamond Dusted ILM Elevator, 12-7523 There may be voids located in the seal of Tyvek pouches associated with ident... Class II
Dec 16, 2025 Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2.... There may be voids located in the seal of Tyvek pouches associated with ident... Class II
Dec 16, 2025 Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS07... There may be voids located in the seal of Tyvek pouches associated with ident... Class II
Dec 16, 2025 25GA Subretinal Injection Cannula VS0220.25 There may be voids located in the seal of Tyvek pouches associated with ident... Class II
Dec 16, 2025 Tecfen Retractable Membrane Polisher, QTPR1267-23 There may be voids located in the seal of Tyvek pouches associated with ident... Class II
Dec 16, 2025 Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25 There may be voids located in the seal of Tyvek pouches associated with ident... Class II
Dec 16, 2025 Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 I... There may be voids located in the seal of Tyvek pouches associated with ident... Class II
Dec 16, 2025 Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS02... There may be voids located in the seal of Tyvek pouches associated with ident... Class II
Dec 16, 2025 Vortex Surgical I2 Injection Kit, VS0500 There may be voids located in the seal of Tyvek pouches associated with ident... Class II
Dec 16, 2025 Vortex Surgical TID Pharos Illuminated Depressor, VS0801B XXX Class II
Dec 16, 2025 Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA L... There may be voids located in the seal of Tyvek pouches associated with ident... Class II
Dec 16, 2025 Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA C... There may be voids located in the seal of Tyvek pouches associated with ident... Class II
Nov 19, 2025 Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25; Reason for the voluntary recall is some products in this lot are not passing ... Class II
Dec 18, 2023 Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25 Reason for the voluntary recall is residue was identified on the two forceps ... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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