FDA DevicesClass II
Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
Published: February 11, 2026Recall ID: Z-1256-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
Additional Source Details
| Field | Value |
|---|---|
| City | Saint Charles |
| State | MO |
| Event id | 98255 |
| Address 1 | 4 Research Park Dr Ste 124 |
| Address 2 | N/A |
| Code info | Pouch UDI 810123483655 Box UDI 810123483662 Lot 2408035 |
| Postal code | 63304-5639 |
| Report date | 20260211 |
| Product type | Devices |
| Product quantity | 14,789 (8651 US; 6138 OUS) |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251216 |
| Initial firm notification | Letter |
| Center classification date | 20260204 |
Overview
- Recalling FirmVortex Surgical Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide 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, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.