Device recall: Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
Class I FDA enforcement event 99069. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Argon Medical Devices, Inc started this device recall on 1 Jun 2026. The firm address in the FDA record is in Athens, TX. FDA put the recall in Class I. FDA event 99069 has 6 product records. The first FDA enforcement report date is 22 Jul 2026. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
Recalling firm
Argon Medical Devices, Inc, Athens, TX.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
6 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2704-2026 | Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A | 950 | Class I | Ongoing | 22 Jul 2026 |
| Z-2705-2026 | One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular | 200 | Class I | Ongoing | 22 Jul 2026 |
| Z-2706-2026 | General Biospy Tray, REF: GUTS1000 | 1800 | Class I | Ongoing | 22 Jul 2026 |
| Z-2707-2026 | T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL | 850 | Class I | Ongoing | 22 Jul 2026 |
| Z-2708-2026 | Arterial Line Kit 20ga x 6, REF: 400115A | 440 | Class I | Ongoing | 22 Jul 2026 |
| Z-2709-2026 | Bone Marrow Tray, REF: CB0033TL; CB0355TLA | 680 | Class I | Ongoing | 22 Jul 2026 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2026
- 572
- Share of these events in Class I
- 12%
- Product records in this event
- 6Median of the firm: 1
- Events of the firm on the register
- 23
Other events of the firm
Official channels
- FDA enforcement report Z-2704-2026The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 99069. https://recallregister.com/fda/i/99069/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
- What quantity of product is in FDA event 99069?
- The event has 6 product records. The first record gives this quantity:
950
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2026 have the same class?
- 12% of the 572 device events that started in 2026 are in Class I.