CLASS II ONGOING Device recall · Reported 11 Feb 2026 · FDA Enforcement Report
Convenience Kits recalled by Vortex Surgical
Vortex Surgical is recalling Convenience Kits 1, distributed nationwide in the US. The recall was initiated on 16 Dec 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1249-2026
- FDA event ID
- 98255
- Recalling firm
- Vortex Surgical, Saint Charles, MO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Dec 2025
- FDA classified
- 4 Feb 2026
- Reported
- 11 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 16 Dec 2025 | Recall initiated by company | |
| 4 Feb 2026 | Classified by FDA | +50 days |
| 11 Feb 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaConnecticutFloridaHawaiiIowaIllinoisIndianaKentuckyMassachusettsMichiganMinnesotaMississippiNorth CarolinaNebraskaNew JerseyNew MexicoNew York
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
1. 25GA Convenience Kit - FNX Pouch UDI 810123482917 Box UDI 810123482924 Lot 2410055 2. 25GA Convenience Kit - FXX Pouch UDI 810123482429 Box UDI 810123482443 Lot 2411028 3. 25GA Convenience Kit - XES Pouch UDI 810123482412 Box UDI 810123482436 Lot 2410057
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
12 other products · FDA event 98255More recalls from Vortex Surgical
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Lindsell Sutured IOL Marker, VS0390 - Scleral Marker recalled | Vortex Surgical | Sterility | Nationwide |
| Device | CLASS II | Rumex Disposable Diamond Dusted ILM Elevator recalled by Vortex Surgical | Vortex Surgical | Sterility | Nationwide |
| Device | CLASS II | Volk Single Use Vitrectomy Lenses Flat Vitrectomy Lens recalled | Vortex Surgical | Sterility | Nationwide |
| Device | CLASS II | Vortex Disposable Forceps and Cannula recalled by Vortex Surgical | Vortex Surgical | Sterility | Nationwide |
| Device | CLASS II | Subretinal Injection Cannula VS0220.25 recalled by Vortex Surgical | Vortex Surgical | Sterility | Nationwide |
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