Vortex Surgical Inc.: ACTU8 Adaptive Forceps Recalled Due to Residue on Device Tips

Agency Publication Date: February 1, 2024

Summary

Vortex Surgical Inc. is recalling 800 units of Vortex Surgical ACTU8 Adaptive Forceps, 25 GA, due to the discovery of residue on the forceps tips. This residue was identified in a small percentage of forceps tips (0.25%) across two specific production lots. Consumers should immediately stop using the affected surgical devices and contact the manufacturer to arrange for a solution.

Risk

The presence of unidentified residue on surgical forceps tips could lead to patient infection, inflammation, or other adverse tissue reactions during medical procedures. While residue was identified by a customer in Korea, the potential for contamination exists across the affected lots.

What You Should Do

Check your inventory for Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE with Reference Number VS0740.25.
Verify the Lot Numbers on the packaging; the affected products are from Lot Numbers 2212002 and 2212020.
Confirm the UDI/DI code 00810123481132 matches the affected devices.
Immediately stop using any forceps from these identified lots and quarantine them to prevent clinical use.
Contact Vortex Surgical Inc. at their Saint Charles, Missouri location or through your local distributor to report affected units and receive further instructions on returning or replacing the devices.
Contact your healthcare provider or the manufacturer for further clinical instructions or if you have questions regarding previous use of these devices.
For additional information, contact the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Contact manufacturer for instructions

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25

Model / REF:

VS0740.25

Z-0970-2024

UPC Codes:

00810123481132

Lot Numbers:

2212002

2212020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93725

Status: Resolved

Manufacturer: Vortex Surgical Inc.

Sold By: Vortex Surgical Inc.; Medical distributors

Manufactured In: United States

Units Affected: 800 devices

Distributed To: Ohio, Washington, Minnesota, Michigan, Iowa

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your inventory for Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE with Reference Number VS0740.25.

Verify the Lot Numbers on the packaging; the affected products are from Lot Numbers 2212002 and 2212020.

Confirm the UDI/DI code 00810123481132 matches the affected devices.

Immediately stop using any forceps from these identified lots and quarantine them to prevent clinical use.

Contact Vortex Surgical Inc. at their Saint Charles, Missouri location or through your local distributor to report affected units and receive further instructions on returning or replacing the devices.

Contact your healthcare provider or the manufacturer for further clinical instructions or if you have questions regarding previous use of these devices.

For additional information, contact the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.