Argon Medical Devices General Biospy Tray Recall: Sterility Risk
Argon Medical Devices recalls General Biospy Tray REF GUTS1000 due to potential sterility issues in lidocaine kits. Affected units have specific lot numbers and expiration dates.
Lower-risk 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.
Contact the company
What happened, in plain English
Argon Medical Devices is recalling General Biospy Trays with reference number GUTS1000 because the lidocaine injection kits inside may not meet sterility standards. This could pose a risk of infection during medical procedures if the kits are used without proper sterility. Read more at govinfonow.com/recall/49048-argon-medical-devices-general-biospy-tray-recall-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/49048-argon-medical-devices-general-biospy-tray-recall-sterility-risk · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2706-2026
Cite this page
“Argon Medical Devices General Biospy Tray Recall: Sterility Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49048-argon-medical-devices-general-biospy-tray-recall-sterility-risk. Based on FDA recall #Z-2706-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2706-2026%22&limit=1).
Why it’s dangerous
The lidocaine injection kits inside the trays may not meet sterility standards as required by regulatory agencies. This could lead to infections if the kits are used during medical procedures without proper sterility checks.
Who’s affected
Healthcare professionals using the General Biospy Tray with specific lot numbers and expiration dates are likely affected. Patients receiving procedures using these trays may be at risk if the lidocaine kits are not sterile.
How to tell if you have this one
Check for the reference number GUTS1000 on the tray. The lot number is 20886333001594 with an expiration date of March 31, 2028. The product is sold in specific packaging with the expiration date and lot number.
- Brand
Argon Medical Devices- Category
Medical device
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Ongoing- Distribution
Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2704-2026 | Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A; REF/UDI-DI Box:Unit/Lot(Expiration): 008416A/20886333217636:00886333217632/11656898(7/19/2027); 008566A/20886333217643:00886333217649/11654475(12/31/2026), 11654478(7/19/2027) | 950 |
| Z-2705-2026 | One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular; REF/UDI-DI Box:Unit/Lot(Expiration): 497434/20886333214499:00886333214495/11656891(7/19/2027); 497455/20886333214635:00886333214631/11658984 (7/19/2027); | 200 |
| Z-2706-2026 | General Biospy Tray, REF: GUTS1000; REF/UDI-DI Box:Unit/Lot(Expiration): GUTS1000/20886333001594:00886333001590/11649760(3/31/2028) | 1800 |
| Z-2707-2026 | T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL; REF/UDI-DI Box:Unit/Lot(Expiration): BMT1104STL/20886333007862:00886333007868/11650679(11/30/2026); BMET1104TL/20886333007602:00886333007608/11654764(3/31/2028); BMT1104CATL/20886333007763:00886333007769/11650887(11/30/2026) | 850 |
| Z-2708-2026 | Arterial Line Kit 20ga x 6, REF: 400115A; REF/UDI-DI Box:Unit/Lot(Expiration): 400115A/20886333212884:00886333212880/11655174(7/19/2027), 11655183(7/19/2027), 11655185(7/19/2027), 11659131(7/19/2027); | 440 |
| Z-2709-2026 | Bone Marrow Tray, REF: CB0033TL; CB0355TLA; 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); | 680 |
What to do — step by step
Check Product Details
Verify the reference number GUTS1000 and lot number 20886333001594 on the tray packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 51 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2706-2026 (June 1, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2706-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.