Z-1256-2026Class II

Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker

Name: Z-1256-2026 Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
Creator: Vortex Surgical Inc.
Published: 2025-12-16
License: https://open.fda.gov/license/

Vortex Surgical, Inc. / initiated 2025-12-16 / Open, Classified / root cause: manufacturing process

FDA source

Vortex Surgical Inc. began a recall of Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker on 2025-12-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1256-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-16
Posted: 2026-02-04
Recalling firm: Vortex Surgical, Inc.
Product: Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
Product code: HMQ Marker, Sclera
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On December 16, 2025, the firm began notifying customers via "URGENT: MEDICAL DEVICE RECALL" letters. Customers were instructed to discontinue use of affected product and to return product for Vortex Surgical to evaluate the seals; use UPS account 23623Y to ship unused products to Vortex Surgical Inc for replacement or refund at: Attn: Andrew Ritts Recall Tyvek Seal, Vortex Surgical Inc., 4 Research Park Dr., Suite 124, St. Charles, MO 63304; complete and return the Acknowledgement and Receipt Form via mail or email to: [email protected]. Actions have been implemented to improve training of individuals associated with sealing and inspecting seals to prevent reoccurrence. The sealer associated with the issue is being updated to include a guard to prevent reoccurrence. If you have any questions, contact the Director of Regulatory Affairs at 635-778-4350 or email to: [email protected] from 8am to 5pm.
Quantity in commerce: 14,789 (8651 US; 6138 OUS)
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, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.
Product codes and lots: Pouch UDI 810123483655 Box UDI 810123483662 Lot 2408035

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1256-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1244-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-04
Z-1245-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-04
Z-1246-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-04
Z-1247-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-04
Z-1248-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-04
Z-1249-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-04
Z-1250-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-04
Z-1251-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-04
Z-1252-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-04
Z-1253-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-04
Z-1254-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-04
Z-1255-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-04
Z-1256-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-04

Product code HMQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)