General Biospy Tray, REF: GUTS1000
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- Agency
- FDA Device
- Recall date
- Jun 1, 2026
- Status
- Ongoing
- Company
- Argon Medical Devices, Inc
1. What product was recalled?
Arterial Line Kit 20ga x 6, REF: 400115A
Arterial Line Kit 20ga x 6, REF: 400115A
Quantity: 440
Code or lot text: 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);
- LOT
- 11655183(7/19/2027)
- LOT
- 11655185(7/19/2027)
- LOT
- 11659131(7/19/2027)
- LOT
- REF/UDI-DI Box:Unit/Lot(Expiration): 400115A/20886333212884:00886333212880/11655174(7/19/2027)
- RECALL-NUMBER
- Z-2708-2026
Bone Marrow Tray, REF: CB0033TL
Bone Marrow Tray, REF: CB0033TL; CB0355TLA
Quantity: 680
Code or lot text: 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);
- LOT
- 11652276(3/31/2028)
- LOT
- CB0355TLA/20886333217698:00886333217694/11651977(3/31/2028)
- LOT
- REF/UDI-DI Box:Unit/Lot(Expiration): CB0033TL/20886333217308:00886333217304/11650820(3/31/2028)
- RECALL-NUMBER
- Z-2709-2026
General Biospy Tray, REF: GUTS1000
General Biospy Tray, REF: GUTS1000
Quantity: 1800
Code or lot text: REF/UDI-DI Box:Unit/Lot(Expiration): GUTS1000/20886333001594:00886333001590/11649760(3/31/2028)
- LOT
- REF/UDI-DI Box:Unit/Lot(Expiration): GUTS1000/20886333001594:00886333001590/11649760(3/31/2028)
- RECALL-NUMBER
- Z-2706-2026
One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
Quantity: 200
Code or lot text: REF/UDI-DI Box:Unit/Lot(Expiration): 497434/20886333214499:00886333214495/11656891(7/19/2027); 497455/20886333214635:00886333214631/11658984 (7/19/2027);
- LOT
- 497455/20886333214635:00886333214631/11658984 (7/19/2027)
- LOT
- REF/UDI-DI Box:Unit/Lot(Expiration): 497434/20886333214499:00886333214495/11656891(7/19/2027)
- RECALL-NUMBER
- Z-2705-2026
T-Lok Bone Marrow Tray, REF: BMT1104STL
T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL
Quantity: 850
Code or lot text: 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)
- LOT
- BMET1104TL/20886333007602:00886333007608/11654764(3/31/2028)
- LOT
- BMT1104CATL/20886333007763:00886333007769/11650887(11/30/2026)
- LOT
- REF/UDI-DI Box:Unit/Lot(Expiration): BMT1104STL/20886333007862:00886333007868/11650679(11/30/2026)
- RECALL-NUMBER
- Z-2707-2026
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
Quantity: 950
Code or lot text: 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)
- LOT
- 008566A/20886333217643:00886333217649/11654475(12/31/2026)
- LOT
- 11654478(7/19/2027)
- LOT
- REF/UDI-DI Box:Unit/Lot(Expiration): 008416A/20886333217636:00886333217632/11656898(7/19/2027)
- RECALL-NUMBER
- Z-2704-2026
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
View source evidence for state distribution
- Puerto Rico: Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. Recall Index urgency is urgent, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- created
10. Where is the official source?
Open the official FDA Device source
Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.