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Limited official informationFDA Medical Device Enforcement ReportsRecall date: Jul 22, 2026

General Biospy Tray, REF: GUTS1000

Full official product description

General Biospy Tray, REF: GUTS1000 | Arterial Line Kit 20ga x 6, REF: 400115A | Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A | One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular | T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL | Bone Marrow Tray, REF: CB0033TL; CB0355TLA

Verification delayed

The last verified facts remain visible. Last successful verification: Aug 5, 2026, 7:44 AM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

Missing: action, consumer scope. The page is public for lookup but excluded from search indexing and advertising.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

General Biospy Tray, REF: GUTS1000; Arterial Line Kit 20ga x 6, REF: 400115A; plus 4 additional official variants listed below.

6 official variants

Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
General Biospy Tray, REF: GUTS1000REF/UDI-DI Box:Unit/Lot(Expiration): GUTS1000/20886333001594:00886333001590/11649760(3/31/2028)1800Z-2706-2026
Arterial Line Kit 20ga x 6, REF: 400115AREF/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);440Z-2708-2026
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566AREF/UDI-DI Box:Unit/Lot(Expiration): 008416A/20886333217636:00886333217632/11656898(7/19/2027); 008566A/20886333217643:00886333217649/11654475(12/31/2026), 11654478(7/19/2027)950Z-2704-2026
One-Piece Introducer Tray, REF: 497455, 497434 cardiovascularREF/UDI-DI Box:Unit/Lot(Expiration): 497434/20886333214499:00886333214495/11656891(7/19/2027); 497455/20886333214635:00886333214631/11658984 (7/19/2027);200Z-2705-2026
T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATLREF/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)850Z-2707-2026
Bone Marrow Tray, REF: CB0033TL; CB0355TLAREF/UDI-DI Box:Unit/Lot(Expiration): CB0033TL/20886333217308:00886333217304/11650820(3/31/2028), 11652276(3/31/2028); CB0355TLA/20886333217698:00886333217694/11651977(3/31/2028);680Z-2709-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

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 classification: Class I

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.