Vortex Surgical 1. 23GA Laser Probe Curved Cat No. recall: Sterility Concern
Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. 25GA Laser Probe Flex-Tip Cat No.…
Why was Vortex Surgical 1. 23GA Laser Probe Curved Cat No. 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
1. 23GA Laser Probe Curved Pouch UDI 810123480036 Box UDI 810123480180 Lot 2411027 2. 25GA Laser Probe Curved Pouch UDI 810123480043 Box UDI 810123480197 Lot 2411026 3. 25GA Laser Probe Flex-Tip Pouch UDI 810123480111 Box UDI 810123480265 Lot 2411024 2411031 4. 25GA Laser Probe Illuminated Curved Pouch UDI 810123480098 Box UDI 810123480241 Lot 2411025 5. 25GA Laser Probe MaxReach Pouch UDI 810123480135 Box UDI 810123480289 Lot 2410029 2411023 6. 25GA Laser Probe Straight Pouch UDI 810123480012 Box UDI 810123480166 Lot 2411030
- Product
- Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. 25GA Laser Probe Flex-Tip Cat No.…
- Recalling firm
- Vortex Surgical Inc.
- Quantity
- 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.
- Recall date
- February 11, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)