Exact FDA event identifier

Event 96443

4 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: February 21, 2025
Product types: Device
Classifications: Class I
Statuses: Ongoing
Recalling firm wording: MEDLINE INDUSTRIES, LP - Northfield

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D AC PACK, HEART BASIN PACK-LF, K OH COMPONENT PACK, OPEN HEART ADULT PART 1 CDS, OPEN HEART B PACK-LF, OPEN HEART PACK, Z OPEN HEART.

Z-1456-2025

Recall number: Z-1456-2025
Initiated: February 21, 2025
Classification: Class I
Status: Ongoing
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Quantity: 1310 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Medline medical procedure kits, containing Medtronic Aortic Root Cannula

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline medical procedure kits, containing Medtronic Aortic Root Cannula

Code information

CABG OPNHRT S HSP, UDI/DI 10195327449650 (EA) 40195327449651 (case), Lot Numbers 23IBH906, 24EBC446, 24FMC989, 24GME639; CABG OPNHRT S HSP, UDI/DI 10198459089503 (EA) 40198459089504 (case), Lot Numbers 24KMB217, 25AMG162; CARDIAC CABG, UDI/DI 10195327490362 (EA) 40195327490363 (case), Lot Numbers 23LBV500, 24DBS178, 24EBK724, 24FBL825; CARDIAC PACK, UDI/DI 10195327490355 (EA) 40195327490356 (case), Lot Numbers 24CBN830, 24DBS177; DR D AC PACK, UDI/DI 10195327298258 (EA) 40195327298259 (case), Lot Numbers 23HBD834, 23IBF066; HEART BASIN PACK-LF, UDI/DI 10195327047573 (EA) 40195327047574 (case), Lot Numbers 22GMD767, 22JMD290, 23GMC713, 23IMA561, 23KMC902; K OH COMPONENT PACK, UDI/DI 10195327659684 (EA) 40195327659685 (case), Lot Numbers 24EBT996, 24IBR766, 24KBJ595, 24LBQ493; OPEN HEART ADULT PART 1 CDS, UDI/DI 10195327034726 (EA) 40195327034727 (case), Lot Number 24CBG813; OPEN HEART B PACK-LF, UDI/DI 10195327206383 (EA) 40195327206384 (case), Lot Numbers 22IMH938, 22KMC295, 23AMD800, 23DME198, 23GMD603, 23GMI093, 23HMG457, 23IMG457, 23KMJ484, 24AMG704, 24AMI684, 24BMG042, 24GMA506, 24GMA897; OPEN HEART PACK, UDI/DI 10889942934164 (EA) 40889942934165 (case), Lot Number 23JBD049; Z OPEN HEART, UDI/DI 10195327659882 (EA) 40195327659883 (case), Lot Numbers 24EBT606, 24IBE093, 24JBV568, 24KBR945.

Distribution pattern

US: CA, FL, MN, NY, OH, OR, PA, TX, WV

device · product 2 of 4

Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK

Z-1457-2025

Recall number: Z-1457-2025
Initiated: February 21, 2025
Classification: Class I
Status: Ongoing
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Quantity: 468 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.

Code information

TOL DR R PACK, UDI/DI 10195327166304 (ea) 40195327166305 (case), Lot Numbers 22GBL197, 22JBG283; TOL DR R PACK, UDI/DI 10195327273484 (ea) 40195327273485 (case), Lot Numbers 23ABO787, 23EBT153, 23HBB950; TOL DR R PACK, UDI/DI 10195327503390 (ea) 40195327503391 (case), Lot Numbers 24CBL126, 24EBV315, 24EBW136.

Distribution pattern

US: CA, FL, MN, NY, OH, OR, PA, TX, WV

device · product 3 of 4

Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: HEART BASIN PACK-LF

Z-1458-2025

Recall number: Z-1458-2025
Initiated: February 21, 2025
Classification: Class I
Status: Ongoing
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Quantity: 320 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.

Code information

HEART BASIN PACK-LF, UDI/DI 10195327563561 (ea) 40195327563562 (case), Lot Numbers 24BMB798, 24DMH381, 24EMF949, 24GMF161, 24IMB237.

Distribution pattern

US: CA, FL, MN, NY, OH, OR, PA, TX, WV

device · product 4 of 4

Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CPB ADJUNCT PACK, DR. C PACK, PK CUST CV A&B C CO, TOL DR R PACK, TOL DR. C PACK, TOL DR. M PACK.

Z-1459-2025

Recall number: Z-1459-2025
Initiated: February 21, 2025
Classification: Class I
Status: Ongoing
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Quantity: 1247 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.

Code information

TOL DR R PACK, UDI/DI 10198459054242 (ea) 40198459054243 (case), Lot Number 24IBV027; TOL DR. C PACK, UDI/DI 10195327176914 (ea) 40195327176915 (case), Lot Number 22HBX339; TOL DR. CRESCENZO PACK, UDI/DI 10195327273750 (ea) 40195327273751 (case), Lot Numbers 22LBC389, 23EBQ439, 23HBG138; TOL DR. C PACK, UDI/DI 10195327513818 (ea) 40195327513819 (case), Lot Numbers 23KBS878, 24CBB191, 24EBD828; TOL DR. C PACK, UDI/DI 10198459054259 (ea) 40198459054250 (case), Lot Numbers 24FBO426, 24HBP282, 24JBL545, 24LBR173; TOL DR. M PACK, UDI/DI 10195327513825 (ea) 40195327513826 (case), Lot Numbers 23KBC932, 24CBP602, 24EBV519; TOL DR. M PACK, UDI/DI 10198459054266 (ea) 40198459054267 (case), Lot Numbers 24GBI558, 24GBX898, 24IBE173, 24IBE173A, 25ABG352.

Distribution pattern

US: CA, FL, MN, NY, OH, OR, PA, TX, WV