Summary
The FDA issued a Class II for Vortex Surgical I2 Injection Kit, VS0500 by Vortex Surgical Inc.. Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potenti.
Details
Source
Device Recall
External ID
Z-1252-2026
Action Date
2026-02-11
Status
Ongoing
Category
device
Product Description
Vortex Surgical I2 Injection Kit, VS0500
Lot/Code Info: Pouch UDI 810123480920 Box UDI 810123481330 Lot 2411012
Quantity Affected: 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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-16
Company
Saint Charles, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 207 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Vortex Surgical Inc. has 16 FDA actions in our database, including 15 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Vortex Surgical Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Vortex Surgical Inc. have FDA actions?
Vortex Surgical Inc. has 16 FDA actions in our database, including 15 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1252-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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