CLASS I ONGOING Device recall · Reported 16 Apr 2025 · FDA Enforcement Report

Medline medical procedure kits recalled by MEDLINE INDUSTRIES, LP

MEDLINE INDUSTRIES, LP - Northfield is recalling Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as, distributed in 9 states. The recall was initiated on 21 Feb 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesTOL 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.

Quantity recalled468 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1457-2025
FDA event ID: 96443
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Classification: Class I
Status: Ongoing
Recall initiated: 21 Feb 2025
FDA classified: 4 Apr 2025
Reported: 16 Apr 2025
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

21 Feb 2025	Recall initiated by company
4 Apr 2025	Classified by FDA	+42 days
16 Apr 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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

California Florida Minnesota New York Ohio Oregon Pennsylvania Texas West Virginia

Questions about this recall

Is Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as recalled?

Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as on 21 Feb 2025. The recall is Class I and its status is Ongoing. Recall number Z-1457-2025.

Why was it recalled?

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.

Which lots are affected?

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.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from MEDLINE INDUSTRIES, LP - Northfield

All 792

Reported	Class	Recall	Company	Reason	Where
1 Oct 2025Device	CLASS I	Medline medical convenience kits labeled as recalled	MEDLINE INDUSTRIES, LP - Northfield	Device Malfunction	6 states
1 Oct 2025Device	CLASS I	Medline medical convenience kits labeled as recalled	MEDLINE INDUSTRIES, LP - Northfield	Device Malfunction	6 states
3 Sep 2025Device	CLASS I	Medline ReNewal Reprocessed St. Jude Medical Response recalled	MEDLINE INDUSTRIES, LP - Northfield	Particulate Matter	Nationwide
3 Sep 2025Device	CLASS II	The Medline General Surgery Tray is customized to meet recalled	MEDLINE INDUSTRIES, LP - Northfield	Sterility	Nationwide
3 Sep 2025Device	CLASS II	Medline Kits containing BD SureStep Foley Tray Systems recalled	MEDLINE INDUSTRIES, LP - Northfield	Labeling Errors	FL, IL

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