Reported Feb 11, 2026 · Ongoing
Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe…
Vortex Surgical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Vortex Surgical Inc. · 4 Research Park Dr Ste 124 · Saint Charles, MO · 63304-5639
Is this the product you have?
7 of 7 products
| # | Product as published |
|---|---|
| 1 | 23G Laser Probe OS4 Flex-Tip VK401113 |
| 2 | 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 |
| 3 | 23G Laser Probe OS4 Intuitive Exendable VK401323 |
| 4 | 25G Laser Probe OS4 Flex-Tip VK401115 |
| 5 | 25G Laser Probe OS4 Illuminated Flex-Tip VK401215 |
| 6 | 25G Laser Probe OS4 Intuitive Exendable VK401325 |
| 7 | 27G Laser Probe OS4 Intuitive Exendable VK401327 |
- Lot codes and dates
7 of 7 products
Products covered by this recall # Barcodes Product as published 1 81012348371681012348379223G Laser Probe OS4 Flex-Tip Pouch UDI 810123483716 Box UDI 810123483792 Lot 2410031 2 81012348373081012348381523G Laser Probe OS4 Illuminated Flex-Tip Pouch UDI 810123483730 Box UDI 810123483815 Lot 2410034 3 81012348376181012348384623G Laser Probe OS4 Intuitive Exendable Pouch UDI 810123483761 Box UDI 810123483846 Lot 2410033 4 81012348372381012348380825G Laser Probe OS4 Flex-Tip Pouch UDI 810123483723 Box UDI 810123483808 Lot 2410032 2410058 2411022 5 81012348374781012348382225G Laser Probe OS4 Illuminated Flex-Tip Pouch UDI 810123483747 Box UDI 810123483822 Lot 2410035 6 81012348377881012348385325G Laser Probe OS4 Intuitive Exendable Pouch UDI 810123483778 Box UDI 810123483853 Lot 2412025 7 81012348378581012348386027G Laser Probe OS4 Intuitive Exendable Pouch UDI 810123483785 Box UDI 810123483860 Lot 2411021 - Amount recalled
- 14,789 (8651 US; 6138 OUS)
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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