Oertli laser probes recalled over voids in sterile pouch seals
Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states a compromised sterile barrier could lead to infection, and no injuries are reported.
Plain-English summary
This recall by Vortex Surgical Inc. covers Oertli laser probes, covering the 23G Laser Probe OS4 Flex-Tip (VK401113), 23G Laser Probe OS4 Illuminated Flex-Tip (VK401213), 23G Laser Probe OS4 Intuitive Extendable (VK401323) and 25G Laser Probe OS4 Flex-Tip (VK401115), among the catalog numbers listed in the enforcement record.
The record states there may be voids located in the seal of Tyvek pouches associated with the identified catalog numbers and lots, and that a compromised sterile barrier has the potential of bioburden contamination which could lead to infection.
The record lists 14,789 units, of which 8,651 are in the US and 6,138 outside it, with pouch and box UDI codes and lot numbers recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States across the states listed in the record. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities should quarantine affected stock and follow Vortex Surgical's instructions.
The recalled product
- Product
- Oertli 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
- Manufacturer
- Vortex Surgical Inc.
Distribution
Part of a larger recall action
This product is one of 13 recalled by Vortex Surgical Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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