The affected products and recommendations for what to do with the devices below have not changed. 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

The FDA is aware that AVID Medical has issued a letter to affected customers recommending certain convenience kit be corrected prior to continued use by removing components affected by the Huons Co., Ltd. recall.

Affected devices: 

Model/Item Number (Kit) Description (Tray Name) Kit Lot Number UDI
BMCN001-05 CONTINUOUS NERVE BLOCK TRAY 1703122 10809160455128
BMCN001-05 CONTINUOUS NERVE BLOCK TRAY 1707656 10809160455128
BMCN001-05 CONTINUOUS NERVE BLOCK TRAY 1708053 10809160455128
DPGE002-02 18G SINGLE SHOT EPI TRAY 1641713 10809160410325
DPGE002-02 18G SINGLE SHOT EPI TRAY 1641714 10809160410325
DPGE002-02 18G SINGLE SHOT EPI TRAY 1659697 10809160410325
DPGE002-02 18G SINGLE SHOT EPI TRAY 1668209 10809160410325
PM415 BASIC BIOPSY TRAY 1652485 10809160322154
PM415 BASIC BIOPSY TRAY 1656642 10809160322154
PM415 BASIC BIOPSY TRAY 1667835 10809160322154
PM415 BASIC BIOPSY TRAY 1676219 10809160322154
PM415 BASIC BIOPSY TRAY 1682251 10809160322154
PM415 BASIC BIOPSY TRAY 1691940 10809160322154
VARV042-03 UNIV IMAGING BIOPSY TRUCUSTOM 1668365 10809160490822
VARV042-03 UNIV IMAGING BIOPSY TRUCUSTOM 1668366 10809160490822
VARV042-03 UNIV IMAGING BIOPSY TRUCUSTOM 1688166 10809160490822
VARV042-03 UNIV IMAGING BIOPSY TRUCUSTOM 1692637 10809160490822
VARV042-03 UNIV IMAGING BIOPSY TRUCUSTOM 1696930 10809160490822

What to Do

Do not use sodium chloride ampules included in affected kits. Check your stock for convenience kits containing sodium chloride ampules. Quarantine kits until new labels can be printed and affixed to all kits. All remaining components within the kits may continue to be used.

On August 10, AVID Medical sent all affected customers a letter recommending the following actions:

  • Identify, Segregate, and Quarantine all impacted kits. 
  • Add warning labels to affected convenience kits to ensure all users are aware of the actions to take prior to use. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory.
  • This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. If pre-printed labels are needed, please contact your sales representative. 
  • REMOVE AND DISCARD the Sodium Chloride, 0.9%, USP 10 mL Flush ampules prior to use.

Reason for Correction

AVID Medical stated that epidural kits may contain sodium chloride ampules manufactured by Huons Co., Ltd. and recalled by Spectra Medical Devices, LLC, due to concerns of product quality and sterility assurance in the Sodium Chloride Injection 0.9%, USP 10ml. The use of sodium chloride ampules may expose patients to viable microorganisms, endotoxins, and foreign matter that may trigger inflammatory responses and infections. This consideration is of particular importance in critically ill patients and when treatment is administered in close proximity to organs highly susceptible to injury — such as the spinal cord — where it may predispose to abscess formation and subsequent paralysis.

As of August 10, AVID Medical 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 issue should contact AVID Medical at complaints@owens-minor.com.

Additional FDA Resources

  1. FDA Enforcement Report
  2. CDRH Medical Device Recall Database
  3. Related Recalls 

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.

Timeline of Communication Updates

Date Action
09/21/2026 The FDA updated this communication to inform the public that this issue has been classified as a Class I Recall. 
09/02/2026 The FDA issued an Early Alert communication to notify the public of a potentially high-risk device issue.