Saint Charles, MO, United States
Vortex Surgical Inc. recalls
3 recalls recorded since 2018, most recently on 16 December 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 16 December 2025
- Reason
- There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
- Distribution
- Worldwide Distribution: US (nationwide) to states of: 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, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1249-2026, Z-1245-2026, Z-1254-2026, Z-1252-2026, Z-1255-2026, Z-1246-2026, Z-1250-2026, Z-1251-2026, Z-1248-2026, Z-1247-2026, Z-1244-2026, Z-1253-2026 and 1 more
- Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES
- Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. 25GA Laser Probe Flex-Tip Cat No. VS0130.25 4. 25GA Laser Probe Illuminated Curved Cat No. VS01
- Vortex Surgical TID Pharos Illuminated Depressor, VS0801B
- Vortex Surgical I2 Injection Kit, VS0500
- Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27
- Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe OS4 Intuitive Exendable VK401323 4. 25G Laser Probe OS4 Flex-Tip VK401115 5. 25G La
- Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
- Tecfen Retractable Membrane Polisher, QTPR1267-23
- and 5 more product lines
Ongoing Class II Medical devices
- Recall started
- 19 November 2025
- Reason
- Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
- Distribution
- US and Japan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1004-2026
- Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
Terminated Class II Medical devices
- Recall started
- 18 December 2023
- Terminated
- 4 April 2024
- Reason
- Reason for the voluntary recall is residue was identified on the two forceps tips of a customer in Korea. The residue is associated with one lot of forceps tips which were utilized in two lots of ACTU8 Adaptive Forceps Tips occurring in 0.25% of those lots.
- Distribution
- Worldwide - US Nationwide distribution in the states of OH, WA, MN, MI, IA and the country of Republic of Korea
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0970-2024
- Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.