FDA Medical devices recall ·
One-Piece Introducer Tray recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2705-2026
- Date
- (initiated June 1, 2026)
- Company / brand
- Argon Medical Devices, Inc
1445 Flat Creek Rd, Athens, TX, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 200
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
Why was it recalled?
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
REF/UDI-DI Box:Unit/Lot(Expiration): 497434/20886333214499:00886333214495/11656891(7/19/2027); 497455/20886333214635:00886333214631/11658984 (7/19/2027);
Distribution
Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
States: Puerto Rico
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-2705-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.