Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode… — Class I medical device recall Z-2704-2026
Ongoing recall by Argon Medical Devices, Inc, reported 2026-07-22, distributed nationwide. Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to n
| Recall number | Z-2704-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Argon Medical Devices, Inc, Athens, TX, United States |
| Recall initiated | 2026-06-01 |
| Classified | 2026-07-10 |
| Reported by FDA | 2026-07-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | TT |
| Quantity | 950 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00886333217632, 00886333217649, 20886333217636, 20886333217643 |
| Model numbers | 008416A, 008566A |
Product
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2704-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.