FDA-Device2026-07-22Class IPROCESSING DEFECT
Argon Medical Devices General Biopsy Tray recalled for sterility concerns
What this means
Argon Medical Devices is recalling General Biopsy Trays (REF: GUTS1000) that contain Lidocaine HCL Injection ampules. The lidocaine ampules in these kits did not meet sterility release criteria, meaning they may not be safe for use. Approximately 1,800 kits were distributed nationwide and to Trinidad and Tobago.
- If you have this biopsy tray kit, do not use it.
- Contact Argon Medical Devices or your healthcare facility for instructions on returning or destroying the affected product.
- Check your inventory for lot 11649760 (expiration 3/31/2028), UDI-DI 20886333001594.
The agency's original wording
Hazard
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Intended for
Adults
Illnesses reported
None reported
Sold states
Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
Affected count
1800
Manufactured in
1445 Flat Creek Rd, Athens, TX, United States
Products
General Biospy Tray, REF: GUTS1000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2706-2026More Argon Medical Devices recalls
- FDA-Device2026-07-22Argon Medical Devices bone marrow tray kits recalled for sterility failure
- FDA-Device2026-07-22Argon Medical Devices T-Lok Bone Marrow Tray recalled for sterility failure
- FDA-Device2026-07-22Argon Medical Devices One-Piece Introducer Tray recalled for sterility failure in Lidocaine ampules
- FDA-Device2026-07-22Argon Medical Devices pacing electrode trays recalled for sterility failure in lidocaine ampules
- FDA-Device2026-07-22Argon Medical Devices Arterial Line Kit recalled for sterility test failure
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