| 2025-12-16 |
Class II
|
Ongoing |
Z-1256-2026 |
Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker |
— |
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 biob… |
| 2025-12-16 |
Class II
|
Ongoing |
Z-1255-2026 |
Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27 |
— |
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 biob… |
| 2025-12-16 |
Class II
|
Ongoing |
Z-1254-2026 |
Vortex Surgical TID Pharos Illuminated Depressor, VS0801B |
— |
XXX |
| 2025-12-16 |
Class II
|
Ongoing |
Z-1253-2026 |
Rumex Disposable Diamond Dusted ILM Elevator, 12-7523 |
— |
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 biob… |
| 2025-12-16 |
Class II
|
Ongoing |
Z-1252-2026 |
Vortex Surgical I2 Injection Kit, VS0500 |
— |
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 biob… |
| 2025-12-16 |
Class II
|
Ongoing |
Z-1251-2026 |
Tecfen Retractable Membrane Polisher, QTPR1267-23 |
— |
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 biob… |
| 2025-12-16 |
Class II
|
Ongoing |
Z-1250-2026 |
Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25 |
— |
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 biob… |
| 2025-12-16 |
Class II
|
Ongoing |
Z-1249-2026 |
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25… |
— |
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 biob… |
| 2025-12-16 |
Class II
|
Ongoing |
Z-1249-2026 |
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25… |
— |
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 biob… |
| 2025-12-16 |
Class II
|
Ongoing |
Z-1248-2026 |
25GA Subretinal Injection Cannula VS0220.25 |
— |
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 biob… |
| 2025-12-16 |
Class II
|
Ongoing |
Z-1247-2026 |
Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS… |
— |
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 biob… |
| 2025-12-16 |
Class II
|
Ongoing |
Z-1246-2026 |
Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Las… |
— |
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 biob… |
| 2025-12-16 |
Class II
|
Ongoing |
Z-1245-2026 |
Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. … |
— |
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 biob… |
| 2025-12-16 |
Class II
|
Ongoing |
Z-1244-2026 |
Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD |
— |
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 biob… |
| 2025-11-19 |
Class II
|
Ongoing |
Z-1004-2026 |
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 through a 25ga cannula smoothly. |
| 2023-12-18 |
Class II
|
Terminated |
Z-0970-2024 |
Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25 |
— |
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… |