Disposable forceps and cannulas recalled over voids in 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 Vortex Disposable Forceps and Cannula, covering the 23GA ACTU8 Forceps Adaptive (VS0740.23), 25GA ACTU8 Forceps Adaptive (VS0740.25), 25GA ACTU8 Forceps ILM (VS0744.25) and 25GA ACTU8 Forceps ILM-Myopic (VS0744.25-35), 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
- Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS0740.25 3. 25GA ACTU8 Forceps ILM VS0744.25 4. 25GA ACTU8 Forceps ILM -Myopic VS0744.25-35 5. 25GA ACTU8 Forceps Pro-Grip VS0713.25 6. 25GA ACTU8
- 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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