FDA Medical devices recall ·
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2704-2026
- 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
- 950
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
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): 008416A/20886333217636:00886333217632/11656898(7/19/2027); 008566A/20886333217643:00886333217649/11654475(12/31/2026), 11654478(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-2704-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.