Recall Z-2709-2026
Argon Medical Devices, Inc · initiated June 1, 2026
Class I – dangerous or defective products that could cause serious health problems or death
Product
Bone Marrow Tray, REF: CB0033TL; CB0355TLA
Codes / lots: 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);
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.
FDA-determined cause: Material/Component Contamination
Action taken
On 6/1/2026, correction notices were sent to customers who were asked to do the following: 1) Do not use the affected Lidocaine vials included in affected Kits and Sets in scope of this notice 2) Review your inventory for any product covered by this Medical Device Notification. If any items from the affected lot are identified: - Place a copy of this notice with the affected product - Apply the enclosed stickers to the packaging (kit) to clearly identify the item and remind users to discard affected lidocaine. 3) At the point of use, upon opening the kit, discard the affected Lidocaine vials in accordance with your facility's procedures. 4) Obtain Lidocaine separately through your facility pharmacy and prepare / administer it per institutional protocols prior to the procedure. 5) Complete and return the response form via email Arbee.cummings@argonmedical.com
Details
- Recall number
- Z-2709-2026
- Initiated
- June 1, 2026
- Posted by FDA
- July 10, 2026
- Product code
- KNW – Instrument, Biopsy
- Quantity
- 680
- Distribution
- Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
- Recalling firm
- Argon Medical Devices, Inc, Athens, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2704-2026 Class I | Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A…Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to… | 06/01/2026Open, Classified |
| Z-2705-2026 Class I | One-Piece Introducer Tray, REF: 497455, 497434 cardiovascularKits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to… | 06/01/2026Open, Classified |
| Z-2706-2026 Class I | General Biospy Tray, REF: GUTS1000Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to… | 06/01/2026Open, Classified |
| Z-2707-2026 Class I | T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATLKits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to… | 06/01/2026Open, Classified |
| Z-2708-2026 Class I | Arterial Line Kit 20ga x 6, REF: 400115AKits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to… | 06/01/2026Open, Classified |