FDA Device recall Z-2706-2026
General Biospy Tray, REF: GUTS1000
- FDA Device
- Class I
- ongoing
- Published 2026-07-22
On 2026-07-22 the FDA classified a Class I recall of General Biospy Tray, REF: GUTS1000 by Argon Medical Devices, citing kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2706-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-06-01 |
| Published | 2026-07-22 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Argon Medical Devices |
| Distribution | US |
Product
General Biospy Tray, REF: GUTS1000
Reason
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Identifiers
| code_info | REF/UDI-DI Box:Unit/Lot(Expiration): GUTS1000/20886333001594:00886333001590/11649760(3/31/2028) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2706-2026%22
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