- Recalling firm
- Argon Medical Devices, Inc
- Reason for recall
- Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- Affected products (lot / model / serial)
- REF/UDI-DI Box:Unit/Lot(Expiration): CB0033TL/20886333217308:00886333217304/11650820(3/31/2028), 11652276(3/31/2028); CB0355TLA/20886333217698:00886333217694/11651977(3/31/2028);
- Units affected
- 680
- Distribution pattern
- Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
- Firm location
- Athens, TX, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2709-2026
- Recall initiated
- June 1, 2026
- FDA classification date
- July 10, 2026
- FDA report date
- July 22, 2026
- FDA event ID
- 99069
- Last updated on HTM Vibe
- July 28, 2026