This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.

Affected Product

Example Kit with Lidocaine and Saline Solution-both circled

The FDA is aware that Arrow International has issued a letter to affected customers recommending certain convenience kits be corrected prior to continued use. Affected devices:

  • Arrow Kits and Sets that contain 0.9% sodium chloride (10mL saline solution ampule) and Lidocaine 
  • Arrow Kits and Sets containing Lidocaine and Bupivacaine
  • Full list of affected products

What to Do

Do not use the affected saline ampule and lidocaine included in affected Arrow kits.

On April 2026, Arrow International sent all affected customers a letter recommending the following actions:

  • Do not use the affected 0.9% sodium chloride (10mL saline ampule) and lidocaine included in affected Arrow kits. Do not use the Lidocaine and Bupivacaine in the kits.
  • At the point of use, discard the affected saline, lidocaine and bupivacaine ampules upon opening the kit.
  • Obtain 0.9% sodium chloride (saline solution), bupivacaine and lidocaine separately through your facility pharmacy and prepare / administer it per institutional protocols prior to the procedure.
  • Ensure all relevant personnel in your organization are informed of this notice.

Reason for Correction

Arrow International, a Teleflex subsidiary, is removing saline, bupivacaine and lidocaine ampules manufactured by Huons Co. Ltd from certain convenience kits. Huons Co., Ltd. initiated a recall of saline, bupivacaine and lidocaine.

Risks of using compromised injectables include infection, inflammatory response and/or reduced or lack of anesthetic effectiveness.  Use of Lidocaine or bupivacaine with reduced or lack of anesthetic effectiveness, may result in ineffective pain control leading to varying degrees of pain, surgical complications, such as emergency conversion   and/or repeat or delayed treatment, and/or patient distress.

As of April 20, 2026, Arrow International has reported no serious injuries and no deaths associated with this issue.

Device Use

Convenience kits contain various surgical instruments, dressings and/or other materials, and pharmaceutical components that are intended to be used during various surgical procedures.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Arrow International at Recalls@teleflex.com or 1-866-396-2111.

Additional FDA Resources

Additional Company Resources

Company-provided information is posted here by the FDA as a public service.

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.