Medline Medical Procedure Kits Recall: Excess Material Risk in Aortic Cannula
Medline recalls medical procedure kits with Medtronic Aortic Root Cannula due to potential excess material in male lures. Affected kits have specific labels and lot numbers. Consumers should contact Medline for details.
Recall notice
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.
Contact the company
What happened, in plain English
Medline is recalling medical procedure kits that include Medtronic Aortic Root Cannula because of a potential excess material in the male lures. This could cause issues during medical procedures if not properly managed. Read more at govinfonow.com/recall/52782-medline-medical-procedure-kits-recall-excess-material-risk-in-aortic.
Source Summary by GovInfoNow · govinfonow.com/recall/52782-medline-medical-procedure-kits-recall-excess-material-risk-in-aortic · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1457-2025
Cite this page
“Medline Medical Procedure Kits Recall: Excess Material Risk in Aortic Cannula.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52782-medline-medical-procedure-kits-recall-excess-material-risk-in-aortic. Based on FDA recall #Z-1457-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1457-2025%22&limit=1).
Why it’s dangerous
The recall is due to potential excess material in the male lures of the aortic cannula. This could lead to complications during medical procedures if the material causes improper function or blockage.
Who’s affected
Medical professionals using these kits are most at risk. Patients undergoing procedures with these kits may also be affected.
How to tell if you have this one
Check for the label 'TOL DR R PACK' on the kit. Lot numbers include 22GBL197, 22JBG283, 23ABO787, 23EBT153, 23HBB950, 24CBL126, 24EBV315, 24EBW136.
- Brand
Medline- Category
Medical device
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Ongoing- Distribution
US: CA, FL, MN, NY, OH, OR, PA, TX, WV
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1456-2025 | 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.; 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. | 1310 units |
| Z-1457-2025 | Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK; 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. | 468 units |
| Z-1458-2025 | Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: HEART BASIN PACK-LF; HEART BASIN PACK-LF, UDI/DI 10195327563561 (ea) 40195327563562 (case), Lot Numbers 24BMB798, 24DMH381, 24EMF949, 24GMF161, 24IMB237. | 320 units |
| Z-1459-2025 | 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.; 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. | 1247 units |
What to do — step by step
Check Kit Label
Look for the label 'TOL DR R PACK' on the medical procedure kit.
Where it went and when
Where it was distributed
Distributed in 9 states.
FDA distribution: “US: CA, FL, MN, NY, OH, OR, PA, TX, WV” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, Minnesota, New York, Ohio, Oregon, Pennsylvania, Texas, West Virginia.
Recall timeline
FDA published this recall 54 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1457-2025 (February 21, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1457-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.